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  • CLASSES

    Keratolytic Agents
    Other Topical Anti-Acne Products
    Topical Antipsoriasis Products
    Topical Scalp Antipsoriasis and Seborrheic Dermatitis Agents, including Keratolytics

    DEA CLASS

    OTC, Rx

    DESCRIPTION

    Topical keratolytic agent
    Used for hyperkeratotic skin disorders such as common and plantar warts, psoriasis, seborrheic dermatitis, calluses, and corns; also used for acne
    Prolonged or repeated daily use over large areas may cause salicylism, especially in children and patients with renal or hepatic impairment

    COMMON BRAND NAMES

    Akurza, Aliclen, Bensal HP, Clear Away, Clear Away Liquid, Clear Away One Step, Clear Away Plantar, Clearasil 3-in-1, Clearasil Blackhead Clearing Scrub, Clearasil Oil Control, Clearasil Total Control, Clearasil Ultra Astringent, Clearasil Ultra Scrub, Compound W, Corn/Callus Remover, Curad Mediplast, Dermarest Psoriasis Moisturizer, Dermarest Psoriasis Scalp Treatment, Dermarest Psoriasis Shampoo plus Conditioner, Dermarest Psoriasis Skin Treatment, Dr. Scholl's Callus Removers, Dr. Scholl's Extra Thick Callus Remover, Dr. Scholl's One Step Callus Remover, DuoFilm Wart Remover, Gordofilm, Hydrisalic, Ionil, Keralyt, Keralyt Scalp Complete, MOSCO Callus & Corn Remover, MOSCO One Step Corn Remover, Neutrogena Acne Wash, Occlusal-HP, P&S, RE SA, SalAC, Salactic Film, Salacyn, Salex, Salimez, Salimez Forte, Salisol, Salisol Forte, Salitech, Salitech Forte, Salitop, Salvax, Scalpicin 2 in 1 Anti-Dandruff, Selsun Blue, Thera-Sal, UltraSal-ER, VIRASAL, Wart-Off, XALIX

    HOW SUPPLIED

    Akurza/Clearasil Total Control/Clearasil Ultra Scrub/Neutrogena Acne Wash/RE SA/Salacyn/Salex/Salicylic Acid/Salitop Topical Cream: 2%, 6%, 10%
    Akurza/Dermarest Psoriasis Moisturizer/RE SA/Salacyn/Salex/Salicylic Acid/Salitech/Salitech Forte/Salitop Topical Lotion: 2%, 5%, 6%
    Aliclen/Ionil/Keralyt/Keralyt Scalp Complete/P&S/Salex/Salicylic Acid/Selsun Blue Topical Shampoo: 2%, 3%, 5%, 6%
    Bensal HP Topical Ointment: 3%
    Clear Away Liquid/Compound W/Corn/Callus Remover/Dermarest Psoriasis Scalp Treatment/DuoFilm Wart Remover/Gordofilm/MOSCO Callus & Corn Remover/Occlusal-HP/Salactic Film/Salicylic Acid/Salisol/Salisol Forte/Scalpicin 2 in 1 Anti-Dandruff/UltraSal-ER/VIRASAL/Wart-Off/XALIX Topical Sol: 3%, 17%, 17.6%, 23%, 26%, 27.5%, 28%, 28.5%
    Clear Away/Clear Away One Step/Clear Away Plantar/Compound W/Curad Mediplast/Dr. Scholl's Callus Removers/Dr. Scholl's Extra Thick Callus Remover/Dr. Scholl's One Step Callus Remover/MOSCO One Step Corn Remover/Salicylic Acid Topical Disc: 40%
    Clearasil 3-in-1/Clearasil Blackhead Clearing Scrub/Clearasil Oil Control/Clearasil Ultra Astringent/Neutrogena Acne Wash Topical Susp: 2%
    Compound W/Dermarest Psoriasis Skin Treatment/Keralyt/Keralyt Scalp Complete/Salicylic Acid Topical Gel: 3%, 5%, 6%, 17%
    Neutrogena Acne Wash Topical Soap: 2%
    Salicylic Acid/Salvax Topical Foam: 6%

    DOSAGE & INDICATIONS

    For the treatment of verruca vulgaris, verruca plantaris, and hyperkeratotic lesions (e.g., corns and calluses).
    Topical dosage (17% gel and liquid)
    Adults, Adolescents, and Children

    Apply 1 drop at a time to sufficiently cover the wart, corn, or callus; avoid applying to healthy skin. Allow to dry. Repeat once or twice daily as needed (until wart, corn, or callus is removed) for up to 12 weeks. NOTE: Topical salicylic acid is recommended for the treatment of cutaneous warts in children ; however, data specific to young children is limited. A 15% topical patch is indicated for children 2 years and older, whereas the topical jelly containing 40% salicylic acid has been reported in children 4 years and older.

    Topical dosage (40% medicated topical patches)
    Adults, Adolescents, and Children

    Apply 1 patch to wart, callus, or corn. Repeat every 48 hours as needed for up to 12 weeks. NOTE: Topical salicylic acid is recommended to treat cutaneous warts in children ; however, data specific to young children is limited. A 15% topical patch is indicated for children 2 years and older, whereas the topical jelly containing 40% salicylic acid has been reported in children 4 years and older.

    Topical dosage (15% medicated topical patches)
    Adults, Adolescents, and Children 2 years and older

    Apply 1 patch at bedtime and remove in the morning after at least 8 hours. Repeat every 24 hours until wart is removed for up to 12 weeks. Patches may be trimmed to the appropriate size to cover the wart, but avoid contact with healthy skin.

    Topical dosage (23%, 26%, 27.5%, 28%, and 28.5% topical liquid)
    Adults, Adolescents, and Children

    Apply to entire wart surface using supplied brush; avoid applying to healthy skin. Allow first application to dry and repeat. Apply once or twice daily. Maximum resolution may be expected after 4 to 6 weeks. NOTE: Topical salicylic acid is recommended to treat cutaneous warts in children ; however, data specific to young children is limited. A 15% topical patch is indicated for children 2 years and older, whereas the topical jelly containing 40% salicylic acid has been reported in children 4 years and older.

    Topical dosage (6% topical gel, cream, and lotion)
    Adults, Adolescents, and Children 2 years and older

    Apply to affected area at bedtime. Cover the treated area. In those areas where occlusion is difficult or impossible, application may be made more frequently. Wash off in the morning.

    Topical dosage (6% topical foam)
    Adults, Adolescents, and Children 2 years and older

    Apply to the affected area twice daily and rub in until completely absorbed.

    Topical dosage (10% cream)
    Adults, Adolescents, and Children 2 years and older

    Apply topically to the affected area at bedtime, and wash off in the morning. Preferably, skin should be hydrated for at least 5 minutes prior to application.

    For the treatment of ichthyosis (i.e., vulgaris, sex-linked and lamellar), keratosis (i.e., palmaris, plantaris, and pilaris) and pityriasis rubra pilaris.
    Topical dosage (6% topical gel, cream and lotion)
    Adults, Adolescents, and Children 2 years and older

    Apply to affected area at bedtime. Cover the treated area. In those areas where occlusion is difficult or impossible, application may be made more frequently. Wash off in the morning. Once clearing is apparent, occasional use will usually maintain the remission.

    Topical dosage (6% topical foam)
    Adults, Adolescents, and Children 2 years and older

    Apply to the affected area twice daily and rub in until completely absorbed.

    Topical dosage (5% topical lotion)
    Adults

    Apply to affected area at bedtime. Cover the treated area. In those areas where occlusion is difficult or impossible, may be applied more frequently.

    Topical dosage (10% cream)
    Adults, Adolescents, and Children 2 years and older

    Apply topically to the affected area at bedtime, and wash off in the morning. Preferably, skin should be hydrated for at least 5 minutes prior to application.

    For the treatment of psoriasis.
    For the treatment of psoriasis involving the body.
    Topical dosage (6% topical gel, cream, and lotion)
    Adults, Adolescents, and Children 2 years and older

    Apply to affected area at bedtime. Cover the treated area. In those areas where occlusion is difficult or impossible, may be applied more frequently. Wash off in the morning.

    Topical dosage (5% topical lotion)
    Adults

    Apply to affected area at bedtime. Cover the treated area. In those areas where occlusion is difficult or impossible, may be applied more frequently.

    Topical dosage (2% and 5% topical gel or 2% and 3% topical lotion)
    Adults, Adolescents, and Children 12 years and older

    Apply to affected area 1 to 4 times daily.

    Topical dosage (10% cream)
    Adults

    Apply topically to the affected area at bedtime, and wash off in the morning. Preferably, skin should be hydrated for at least 5 minutes prior to application.

    For the treatment of scalp psoriasis.
    Topical dosage (shampoo)
    Adults, Adolescents, and Children 2 years and older

    Apply shampoo to scalp after wetting hair. Work into lather, leave on for several minutes, then rinse thoroughly. The shampoo may be used daily until the condition clears, then as needed to maintain remission. Alternatively, to use as concentrated scalp treatment before shampooing, do not wet hair and apply directly to affected areas of scalp. Leave on for 5 minutes initially, gradually increasing to up to 1 hour, then rinse thoroughly with water.

    Topical dosage (topical gel)
    Adults, Adolescents, and Children 2 years and older

    Apply directly to affected areas of the scalp. Leave on for 10 to 20 minutes initially, gradually increasing to up to an hour as treatment progresses. Rinse thoroughly with medicated shampoo or warm water.

    Topical dosage (10% cream)
    Adults, Adolescents, and Children 2 years and older

    Apply topically to the affected area at bedtime, and wash off in the morning. Preferably, skin should be hydrated for at least 5 minutes prior to application.

    For the treatment of seborrheic dermatitis.
    Topical dosage (2% and 5% shampoo)
    Adults, Adolescents, and Children 2 years and older

    Apply to scalp after wetting hair. Work into lather, leave on for several minutes, then rinse thoroughly. The shampoo may be used daily until the condition clears, then as needed to maintain remission.

    Topical dosage (2% and 3% topical preparations)
    Adults, Adolescents, and Children 2 years and older

    Apply to the affected areas 1 to 4 times daily.

    For the treatment of acne vulgaris.
    Topical dosage
    Adults, Adolescents, and Children

    Apply suitable topical preparation containing 0.5% to 2% salicylic acid 1 to 3 times per day. Because excessive drying may occur, start with 1 application daily and gradually increase to 2 to 3 times daily. May reduce application to once every other day if bothersome drying or peeling occurs. NOTE: Salicylic acid concentrations ranging up to 10% have been recommended for acne in adults and children as young as 2 years; however, 2% is the maximum strength allowed in OTC acne products in the United States.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Geriatric

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    No maximum dosage information is available.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustments are needed.

    Renal Impairment

    No dosage adjustments are needed.

    STORAGE

    Generic:
    - Avoid excessive heat (above 104 degrees F)
    - Brief exposure up to 104 degrees F does not adversely affect product
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Akurza :
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Aliclen:
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Bensal HP:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Clear Away:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Clear Away Liquid:
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    Clear Away One Step:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Clear Away Plantar:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Clearasil 3-in-1:
    - Storage information not available
    Clearasil Blackhead Clearing Scrub:
    - Storage information not available
    Clearasil Oil Control:
    - Storage information not available
    Clearasil Total Control:
    - Storage information not available
    Clearasil Ultra Astringent:
    - Storage information not available
    Clearasil Ultra Scrub:
    - Storage information not available
    Compound W:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Corn/Callus Remover:
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    Curad Mediplast:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Dermarest Psoriasis Moisturizer:
    - Store between 59 to 77 degrees F
    Dermarest Psoriasis Overnight Treatment:
    - Storage information not listed
    Dermarest Psoriasis Scalp Treatment:
    - Storage information not listed
    Dermarest Psoriasis Shampoo plus Conditioner:
    - Storage information not provided in labeling
    Dermarest Psoriasis Skin Treatment:
    - Storage information not listed
    Dr. Scholl's Callus Removers:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Dr. Scholl's Extra Thick Callus Remover:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Dr. Scholl's One Step Callus Remover:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    DuoFilm Wart Remover:
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    Gordofilm :
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    Hydrisalic:
    - Store at room temperature (between 59 to 86 degrees F)
    Ionil:
    - Store at room temperature (between 59 to 86 degrees F)
    Ionil Plus:
    - Store at room temperature (between 59 to 86 degrees F)
    Keralyt:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Keralyt Scalp Complete:
    - Store at room temperature (between 59 to 86 degrees F)
    MOSCO Callus & Corn Remover:
    - Avoid excessive heat (above 104 degrees F)
    - Store at room temperature (between 59 to 86 degrees F)
    MOSCO One Step Corn Remover:
    - Protect from extreme heat
    - Store at room temperature (between 59 to 86 degrees F)
    Neutrogena Acne Wash:
    - Storage information not available
    Occlusal-HP:
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    P&S:
    - Storage information not listed
    RE SA :
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    SalAC:
    - Flammable, keep away from heat and flame
    Salactic Film :
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    Salacyn:
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salex:
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salimez:
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salimez Forte:
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salisol :
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salisol Forte :
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salitech:
    - Do not freeze
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salitech Forte:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salitop :
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Salkera:
    - Avoid exposure to heat
    - Protect from freezing
    - Store between 59 to 77 degrees F
    - Store upright
    Salvax:
    - Avoid excessive heat (above 104 degrees F)
    - Do Not Store at Temperatures Above 120 degrees F (49 degrees C)
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    - Store upright
    Scalpicin 2 in 1 Anti-Dandruff:
    - Avoid excessive humidity
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Selsun Blue:
    - Storage information not provided in labeling
    Thera-Sal :
    - Storage information not provided in labeling
    Trans-Ver-Sal:
    - Store below 86 degrees F
    UltraSal-ER:
    - Flammable, keep away from heat and flame
    - Store at room temperature (between 59 to 86 degrees F)
    VIRASAL:
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Wart-Off:
    - Flammable, keep away from heat and flame
    - Store at room temperature not exceeding 86 degrees F
    XALIX:
    - Avoid excessive heat (above 104 degrees F)
    - Brief exposure up to 104 degrees F does not adversely affect product
    - Flammable, keep away from heat and flame
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Salicylate hypersensitivity

    Salicylic acid preparations are contraindicated in patients who have previously exhibited salicylate hypersensitivity.

    Diabetes mellitus, peripheral vascular disease

    Topical salicylic acid preparations in concentrations greater than 6% are contraindicated in patients with diabetes mellitus and other conditions of poor blood circulation such as peripheral vascular disease. Do not use these preparations on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

    Children, hepatic disease, renal impairment

    Prolonged use of salicylic acid over large areas, especially in children and patients with renal impairment or hepatic disease may increase the risk for development of salicylism. In such patients, limit the treated area and closely monitor the patient for signs of salicylate toxicity such as nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnoea, diarrhea, and psychic disturbances. When the potential for toxicity is present, advise patients not to apply occlusive dressings, clothing or other occlusive topical products such as petrolatum-based ointments to prevent excessive systemic exposure to salicylic acid. Concomitant use of other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin and other salicylate containing medications, such as sports injury creams) should be avoided. Discontinue use of salicylic acid if salicylic acid toxicity occurs and treat appropriately.

    Influenza, varicella

    The potential for Reye's syndrome should be considered with administration of salicylic acid products in children and adolescents with varicella or influenza.

    Accidental exposure, ocular exposure

    Avoid accidental exposure of salicylic acid products to the eyes, lips, mucus membranes and inflamed or broken skin as increased absorption may occur. If unintended mucus membrane or ocular exposure occurs, thoroughly rinse affected areas with water.

    Pregnancy

    There are no adequate and well-controlled studies in pregnant women. Salicylic acid products should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

    Breast-feeding

    It is not known whether topically applied salicylic acid is excreted into breast milk. According to the manufacturer, salicylic acid should not be used during breast-feeding. However, if the drug is used by nursing mothers, care should be taken to avoid application to the skin of the breast during lactation; oral ingestion by the infant could be harmful. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    ADVERSE REACTIONS

    Mild

    anaphylactoid reactions / Rapid / 0-1.0
    pruritus / Rapid / Incidence not known
    skin irritation / Early / Incidence not known

    DRUG INTERACTIONS

    Acetaminophen; Aspirin, ASA; Caffeine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Adapalene: (Moderate) Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided.
    Adapalene; Benzoyl Peroxide: (Moderate) Concomitant use of other potentially irritating topical products with adapalene should be done cautiously because of additive local irritation. Particular caution should be exercised in using adapalene in combination with preparations containing salicylic acid. If these preparations have been used, it is advisable not to start therapy with adapalene until the effects of such preparations in the skin have subsided. (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Aminosalicylate sodium, Aminosalicylic acid: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Butalbital; Caffeine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Butalbital; Caffeine; Codeine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Caffeine; Dihydrocodeine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Carisoprodol: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Carisoprodol; Codeine: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Dipyridamole: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Omeprazole: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Oxycodone: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Aspirin, ASA; Pravastatin: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Atropine; Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Benzoic Acid; Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Benzoyl Peroxide: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Benzoyl Peroxide; Clindamycin: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves. (Moderate) When concomitantly prescribed for acne therapy, apply salicylic acid and clindamycin topical solutions separately, at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
    Benzoyl Peroxide; Erythromycin: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Benzoyl Peroxide; Sulfur: (Moderate) Concurrent use of benzoyl peroxide and topical products containing salicylic acid on the same area of skin will cause additive irritant and drying effects. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Bismuth Subsalicylate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Bismuth Subsalicylate; Metronidazole; Tetracycline: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Choline Salicylate; Magnesium Salicylate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Clindamycin: (Moderate) When concomitantly prescribed for acne therapy, apply salicylic acid and clindamycin topical solutions separately, at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
    Clindamycin; Tretinoin: (Moderate) When concomitantly prescribed for acne therapy, apply salicylic acid and clindamycin topical solutions separately, at different times of the day to minimize skin irritation, unless directed otherwise by the prescriber. If skin irritation occurs, a decrease in dose or frequency of one or both agents may be necessary.
    Hyoscyamine; Methenamine; Methylene Blue; Phenyl Salicylate; Sodium Biphosphate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Magnesium Salicylate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Mequinol; Tretinoin: (Moderate) Mequinol; tretinoin (Solage) solution contains a high concentration of ethanol which may be very drying to the skin. The concomitant use of other medications or skin-care items with drying effects can be additive or cause irritation, including astringents, benzoyl peroxide, salicylic acid, medicated soaps/shampoos, or hair waxes.
    Retinoids: (Moderate) Dryness of the skin and mucus membranes are common side effects of retinoid therapy. Simultaneous use of retinoids and topical drying agents, such as salicylic acid, can potentiate the drying effects of retinoids on the skin. Be alert for signs of skin irritation, the offending topical agents may need to be used less often or discontinued during retinoid therapy.
    Salicylates: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.
    Salsalate: (Moderate) Concomitant use of salicylic acid with other drugs which may contribute to elevated serum salicylate levels (e.g., oral aspirin or other oral salicylates and other salicylate containing medications, such as sports injury creams) should be avoided. Concurrent use may result in excessive exposure to salicylic acid. Consider replacing aspirin therapy with an alternative non-steroidal anti-inflammatory agent that is not salicylate based where appropriate.

    PREGNANCY AND LACTATION

    Pregnancy

    There are no adequate and well-controlled studies in pregnant women. Salicylic acid products should only be used during pregnancy if the potential benefit to the mother outweighs the potential risk to the fetus.

    It is not known whether topically applied salicylic acid is excreted into breast milk. According to the manufacturer, salicylic acid should not be used during breast-feeding. However, if the drug is used by nursing mothers, care should be taken to avoid application to the skin of the breast during lactation; oral ingestion by the infant could be harmful. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Salicylic acid exhibits keratolytic action by dissolution of intercellular cement substance causing desquamation of the horny layer of skin.

    PHARMACOKINETICS

    Salicylic acid is administered topically.

    Topical Route

    Following topical application, percutaneous absorption of salicylic acid does occur; however, systemic exposure is considered negligible with normal prescription use. Roughly 10% of applied salicylates can remain in the skin after dermal application; however, acute toxicity via dermal exposure is rarely seen for salicylic acid. Salicylism has occurred using high concentrations of salicylic acid on widespread areas of hyperkeratotic skin, but cases resulting from topically applied salicylic acid cosmetic or acne products have not been reported.