PDR MEMBER LOGIN:
  • PDR Search

    Required field
  • Advertisement
  • CLASSES

    Peroxide Products for Treatment of Acne

    DEA CLASS

    Rx, OTC

    DESCRIPTION

    Topical agent with antibacterial activity, drying actions, sebostatic effects; causes mild skin desquamation.
    Approved topically for the treatment of acne vulgaris; available in prescription and non-prescription products.

    COMMON BRAND NAMES

    Acne Medication, Acne-10, Acneclear, Benprox, Benzac, Benzac AC, Benzac W, Benzagel, BenzaShave, BenzEFoam, BenzEFoam Ultra, BenzePrO, Benziq, BP Cleanser, BP Cleansing Lotion, BP Foaming Wash, BP Gel, BP Topical, BP Wash, BPO, BPO Creamy Wash, BPO Foaming Cloth, Brevoxyl-4, Brevoxyl-8, Clearasil, Clearasil Ultra, Clearasil Vanishing, Clearplex, Clearplex X, Clearskin, Clinac BPO, Del Aqua, Desquam-E, Desquam-X, EFFACLAR, NeoBenz Micro, NeoBenz Micro SD, OC8, Oscion, Pacnex, PanOxyl, PanOxyl AQ, PanOxyl Aqua, Riax, SE BPO, Seba, Seba-Gel, Soluclenz Rx, Theroxide, TL BPO MX, Triaz

    HOW SUPPLIED

    Acne Medication/Acne-10/Benzoyl Peroxide/BP Cleansing Lotion/Brevoxyl-4/Theroxide Topical Lotion: 4%, 5%, 10%
    Acne Medication/Acneclear/Benzac/Benzac AC/Benzac W/Benzagel/Benzoyl Peroxide/BP Gel/BP Topical/BPO/Brevoxyl-4/Brevoxyl-8/Clearplex/Clearplex X/Clinac BPO/Desquam-E/Desquam-X/OC8/Oscion/PanOxyl/PanOxyl AQ/PanOxyl Aqua/Seba/Seba-Gel/Soluclenz Rx/Triaz Topical Gel: 2.5%, 3%, 4%, 5%, 5.5%, 6%, 7%, 8%, 9%, 10%
    Benprox/Benzac AC/Benzac W/BenzePrO/Benziq/Benzoyl Peroxide/BP Cleanser/BP Foaming Wash/BP Wash/Desquam-X/NeoBenz Micro/Pacnex/SE BPO/TL BPO MX Topical Susp: 2.5%, 4.25%, 5%, 5.25%, 6.8%, 6.9%, 7%, 10%, 4-5%, 5-8%
    BenzEFoam/BenzEFoam Ultra/BenzePrO/Benzoyl Peroxide/Riax Topical Foam: 5.2%, 5.3%, 5.5%, 9.5%, 9.7%, 9.8%
    BenzePrO/Benzoyl Peroxide/BPO Foaming Cloth/Triaz Topical Swab: 5.8%, 6%
    Benzoyl Peroxide/BPO Creamy Wash/Brevoxyl-4 Topical Soap: 4-5%, 5-8%
    Benzoyl Peroxide/BPO Creamy Wash/Brevoxyl-4/Clearasil/Clearasil Ultra/Clearasil Vanishing/Clearskin/Del Aqua/EFFACLAR/NeoBenz Micro/NeoBenz Micro SD/PanOxyl Topical Cream: 3.5%, 4%, 5.5%, 8.5%, 10%, 4-5%

    DOSAGE & INDICATIONS

    For the treatment and prevention of mild or moderate acne vulgaris caused by Propionibacterium acnes.
    Topical dosage (creams, gels, solutions, or lotions)
    Adults and Adolescents

    Apply topically to affected area once daily. May gradually increase the number of applications to 4 times per day, as needed. Initiate therapy with 2.5—5% formulations and gradually increase strength to 10% after 3—4 weeks, if needed, or sooner if tolerance to the lower strengths is noted. Improvement usually is noted within 3—4 weeks. Maximum effects are usually seen within 8—12 weeks. Continued use may be required to maintain the desired therapeutic response. Patients with fair skin or patients in arid environments should initiate therapy at once daily intervals and then gradually increase applications as tolerated.

    Topical dosage (foam)
    Adults and Adolescents

    Apply to affected area once daily. For facial acne, apply a dollop the size of a marble; for acne on the back or chest apply a dollop the size of a whole walnut. Adjust frequency of use to obtain the desired clinical response.

    Topical dosage (cleansing lotion, foaming cloths, cleansing bars, or liquid)
    Adults and Adolescents

    Wash affected areas 1 to 3 times per day. Follow recommendations of specific product label.

    Topical dosage (facial mask)
    Adults and Adolescents

    Apply to affected area once weekly to once daily.

    MAXIMUM DOSAGE

    Adults

    No maximum dosage information is available.

    Elderly

    No maximum dosage information is available.

    Adolescents

    No maximum dosage information is available.

    Children

    Safety and efficacy have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Topical Administration

    Do not use near the eyes, nose, mouth, or other mucous membranes. Do not apply to areas of raw or irritated skin.
    Wash hands after applying to remove any remaining medication.
    Instruct patients not to apply other topical products to the same area within 1 hour of applying benzoyl peroxide, unless indicated by the prescriber.

    Cream/Ointment/Lotion Formulations

    Cream or lotion: Before applying benzoyl peroxide, wash affected area with a non-medicated cleanser and pat dry. Apply enough medication to cover the area and rub in gently.

    Other Topical Formulations

    Facial mask: Before applying the mask, wash the affected area with a non-medicated cleanser and pat dry. Using a circular motion, apply a thin layer of the mask evenly over the affected area. Allow mask to dry for as long as directed on package instructions (usually for 15—25 minutes). Rinse the mask off using warm water and then pat dry.
    Foaming Cloths: Wet face and cloth with water. Work cloth into a full lather and use to cleanse face for 10 to 20 seconds. Rinse thoroughly and then pat dry. Throw away cloth; do not flush.
    Foam: Prime container prior to first use. Shake well, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times, remove cap, hold can upright over sink, and firmly depress the actuator for 1 to 3 seconds until tab breaks and foam begins to dispense. Prior to each use, shake well and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Holding can upright, dispense foam into palm of hand and apply to affected area. Rub in until completely absorbed. Wipe off any excess foam from actuator after use.
    Gel: Before applying benzoyl peroxide, wash affected area with a non-medicated cleanser and pat dry. Apply enough medication to cover the area and rub in gently.
    Shaving cream: Wet the area to be shaved. Apply a small amount of cream and gently rub over entire area. Shave, rinse area, and pat dry.
    Cleansing bar, lotion, or liquid: Use to wash affected areas.

    STORAGE

    Generic:
    - 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
    Acne Medication:
    - Store at room temperature (between 59 to 86 degrees F)
    Acne-10:
    - Avoid extreme temperatures
    Acneclear:
    - Store at room temperature (between 59 to 86 degrees F)
    Benprox :
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Benzac:
    - Store at room temperature (between 59 to 86 degrees F)
    Benzac AC:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Benzac W:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Benzagel:
    - Store at room temperature (between 59 to 86 degrees F)
    BenzaShave:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    BenzEFoam:
    - Protect from freezing
    - Store between 59 to 77 degrees F
    - Store upright
    BenzEFoam Ultra :
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    BenzePrO:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Benziq:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Benziq LS:
    - Protect from freezing
    - Store between 59 to 77 degrees F
    BP Cleanser:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    BP Cleansing Lotion:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    BP Foaming Wash:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    BP Gel:
    - Store at room temperature (between 59 to 86 degrees F)
    BP Topical :
    - Store at room temperature (between 59 to 86 degrees F)
    BP Wash:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    BP Wash Kit:
    - Store between 59 to 77 degrees F
    BPO:
    - Store at room temperature (between 59 to 86 degrees F)
    BPO Creamy Wash:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    BPO Foaming Cloth:
    - Store at room temperature (between 59 to 86 degrees F)
    Brevoxyl-4:
    - Store at room temperature (between 59 to 86 degrees F)
    Brevoxyl-8:
    - Store at room temperature (between 59 to 86 degrees F)
    Clearasil:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Clearasil Ultra:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Clearasil Vanishing:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Clearplex :
    - Avoid extreme temperatures
    Clearplex X:
    - Store at room temperature (between 59 to 86 degrees F)
    Clearskin:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Clinac BPO:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Del Aqua:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Delos:
    - Store at room temperature (between 59 to 86 degrees F)
    Desquam-E:
    - Store at room temperature (between 59 to 86 degrees F)
    Desquam-X:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    EFFACLAR:
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Ethexderm BPW:
    - Store at room temperature (between 59 to 86 degrees F)
    Inova Easy Pad:
    - Store at room temperature (between 59 to 86 degrees F)
    Lavoclen-4 :
    - Store at room temperature (between 59 to 86 degrees F)
    Lavoclen-8:
    - Store at room temperature (between 59 to 86 degrees F)
    NeoBenz:
    - Store at room temperature (between 59 to 86 degrees F)
    NeoBenz Micro:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    NeoBenz Micro Cream Plus Pack:
    - Store between 59 to 77 degrees F
    NeoBenz Micro SD:
    - Store at room temperature (between 59 to 86 degrees F)
    NeoBenz Micro Wash Plus Pack:
    - Store between 59 to 77 degrees F
    OC8:
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Oscion:
    - Store at room temperature (between 59 to 86 degrees F)
    Pacnex:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Pacnex HP:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Pacnex LP:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Pacnex MX:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    PanOxyl:
    - Do not freeze
    - Store below 77 degrees F
    PanOxyl AQ:
    - Store at room temperature (between 59 to 86 degrees F)
    PanOxyl Aqua:
    - Store at room temperature (between 59 to 86 degrees F)
    Peroderm:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    RE Benzoyl Peroxide :
    - Store at room temperature (between 59 to 86 degrees F)
    Riax:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    SE BPO:
    - Protect from freezing
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Seba:
    - Avoid extreme temperatures
    Seba-Gel:
    - Store at room temperature (between 59 to 86 degrees F)
    Soluclenz Rx :
    - Avoid extreme temperatures
    Theroxide:
    - Avoid extreme temperatures
    TL BPO MX:
    - Protect from freezing
    - Store at room temperature (between 59 to 86 degrees F)
    Triaz:
    - Store at room temperature (between 59 to 86 degrees F)
    Zaclir:
    - Store at room temperature (between 59 to 86 degrees F)
    Zoderm:
    - Protect from freezing
    - Store at 77 degrees F; excursions permitted to 59-86 degrees F
    Zoderm Redi-Pads :
    - Protect from freezing
    - Store between 59 to 77 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Benzoyl peroxide is contraindicated in individuals having known sensitivity to benzoyl peroxide or any other listed ingredients.

    Skin abrasion, skin disease, sunburn, sunlight (UV) exposure

    Use of benzoyl peroxide products in patients with skin disease such as dermatitis, seborrhea, and eczema or with skin abrasion or inflammation, denuded skin, including sunburn or windburn, may increase the risk of skin irritation. The benzoyl peroxide product should be discontinued until skin sensitivity resolves. Patients should limit their sunlight (UV) exposure and use sunscreen while using benzoyl peroxide products to decrease the risk for skin irritation.

    Accidental exposure, ocular exposure

    Avoid accidental exposure of benzoyl peroxide products to the eyes, lips, mucus membranes and inflamed or raw skin due to severe irritation. If unintended mucus membrane or ocular exposure occurs, thoroughly rinse affected areas with water.

    Children

    The safety and efficacy of benzoyl peroxide products have not been established in children.

    Pregnancy

    Benzoyl peroxide products are considered FDA pregnancy risk category C agents. It is not known if benzoyl peroxide causes fetal harm or can affect reproductive capacity. However, topical application is generally considered safe during pregnancy.

    Breast-feeding

    It is not known if benzoyl peroxide is excreted in breast milk. However, very little benzoic acid is absorbed systemically with topical use of benzoyl peroxide; therefore, minimal risk to the infant would be expected. Only water-miscible cream products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. 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

    Severe

    anaphylactoid reactions / Rapid / 0-1.0

    Moderate

    contact dermatitis / Delayed / Incidence not known
    erythema / Early / Incidence not known

    Mild

    skin irritation / Early / Incidence not known
    xerosis / Delayed / Incidence not known
    pruritus / Rapid / Incidence not known
    rash / Early / Incidence not known

    DRUG INTERACTIONS

    Clindamycin; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
    Dapsone: (Minor) Coadministration of topical benzoyl peroxide-containing products with topical sulfone products, such as dapsone, may cause skin and facial hair to temporarily change color to a yellow/orange color.
    Fluocinolone; Hydroquinone; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided. (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
    Halobetasol; Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used 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.
    Hydroquinone: (Minor) Keratolytic agents or products that contain keratolytic agents, such as benzoyl peroxide, can potentiate the skin irritation caused by hydroquinone and hydroquinone-containing products. Also, concurrent use of topical hydroquinone and topical peroxide (e.g., benzoyl peroxide) on the same area of skin can result in transient dark staining of the skin due to oxidation of hydroquinone. Removal of staining can be accomplished by discontinuing concurrent use and by normal soap cleansing. Concurrent application of such agents should generally be avoided.
    Isotretinoin: (Moderate) Benzoyl peroxide will cause additive irritant and drying effects with concomitant oral isotretinoin use. Reduction in the dose or temporary discontinuation of the benzoyl peroxide product may be needed until skin irritation resolves.
    Mequinol; Tretinoin: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided. (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.
    Porfimer: (Major) Avoid coadministration of porfimer with benzoyl peroxide due to the risk of increased photosensitivity. All patients treated with porfimer will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.
    Salicylic Acid: (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.
    Sodium Thiosulfate; Salicylic Acid: (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.
    Tazarotene: (Moderate) Concomitant use of tazarotene and dermatologic products containing benzoyl peroxide should be avoided. The manufacturer suggests that a patient's skin rest until the effects of such preparations subside before using tazarotene. When used together as part of acne therapy, these medications should be used 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.
    Topical Local Anesthetics: (Moderate) Concurrent use of benzoyl peroxide and topical anesthetics may decrease the efficacy of the anesthetic. In a clinical study, an estimated 75% increase in patient-reported, prick-induced pain was noted in areas treated with both 5% benzoyl peroxide and 6% benzocaine cream as compared to areas treated with 6% benzocaine cream alone. Investigators attributed the decreased anesthetic effect to a breakdown of the benzocaine molecule by either or both benzoyl peroxide or benzoyl peroxide-derived free radicals. It is recommended that the skin area that is to be topically anesthetized have no previous treatment with benzoyl peroxide or that the skin is thoroughly washed prior to the application of the anesthetic.
    Tretinoin, ATRA: (Moderate) Benzoyl peroxide can potentiate the skin irritation caused by topical tretinoin. Concurrent application of these agents on areas treated with tretinoin should be avoided.
    Trifarotene: (Moderate) Avoid concurrent use of trifarotene with other topical products that may dry or irritate the skin, such as benzoyl peroxide.
    Verteporfin: (Moderate) Use caution if coadministration of verteporfin with benzoyl peroxide is necessary due to the risk of increased photosensitivity. Verteporfin is a light-activated drug used in photodynamic therapy; all patients treated with verteporfin will be photosensitive. Concomitant use of other photosensitizing agents like benzoyl peroxide may increase the risk of a photosensitivity reaction.

    PREGNANCY AND LACTATION

    Pregnancy

    Benzoyl peroxide products are considered FDA pregnancy risk category C agents. It is not known if benzoyl peroxide causes fetal harm or can affect reproductive capacity. However, topical application is generally considered safe during pregnancy.

    It is not known if benzoyl peroxide is excreted in breast milk. However, very little benzoic acid is absorbed systemically with topical use of benzoyl peroxide; therefore, minimal risk to the infant would be expected. Only water-miscible cream products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins. 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

    Benzoyl peroxide exhibits antimicrobial effects against Propionibacterium acnes, which is the predominant organism in sebaceous follicles and comedones. The antibacterial effects of benzoyl peroxide are due to the release of free-radical oxygen species, which are capable of oxidizing bacterial proteins. Resolution of acne usually occurs within 4—6 weeks of initiation of treatment. Resolution coincides with a reduction in levels of P. acnes, lipids, and free fatty acids in the skin follicle. Benzoyl peroxide also demonstrates keratolytic activity, which produces drying and desquamative actions that contribute to its efficacy in comedone treatment. In the treatment of decubitus ulcers, benzoyl peroxide stimulates epithelial cell proliferation and the production of granulation tissue.

    PHARMACOKINETICS

    Benzoyl peroxide is applied topically. In the skin, benzoyl peroxide is metabolized to benzoic acid. Approximately 5% of the benzoic acid is systemically absorbed and excreted in the urine.

    Topical Route

    After topical application to the skin, benzoyl peroxide is absorbed through the epidermis. Approximately 5% of the benzoic acid is systemically absorbed.