Acne vulgaris:
Children ≥7 years and Adolescents: Limited data available in ages <12 years (Ref): Topical:
Topical formulations: Apply sparingly once daily; gradually increase to 2 to 3 times daily if needed. If excessive dryness or peeling occurs, reduce dose frequency or concentration. If excessive stinging or burning occurs, remove with mild soap and water; resume use the next day.
Topical cleansers: Wash once or twice daily; control amount of drying or peeling by modifying dose frequency or concentration
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Benzoyl peroxide: Drug information")
Acne vulgaris:
Note: May be used alone or as part of an appropriate combination regimen. Avoid simultaneous application with topical tretinoin (may reduce tretinoin efficacy) (Ref). Consider starting with the lowest possible concentration to minimize skin irritation and increase potency as tolerated (Ref).
Topical:
Topical formulations: Apply sparingly once daily; gradually increase to 2 to 3 times/day if needed. If excessive dryness or peeling occurs, reduce dose frequency or concentration. If excessive stinging or burning occurs, remove with mild soap and water; resume use the next day.
Topical cleansers: Wash once or twice daily; control amount of drying or peeling by modifying dose frequency or concentration.
Rosacea: Cream (Epsolay): Topical: Apply a pea-sized amount to affected area in a thin layer once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%:
Dermatologic: Contact dermatitis (1% to 3%), desquamation (≤5%), erythema of skin (≤5%)
Local: Application-site edema (including application-site swelling: 1%), application-site erythema (2%), application-site pain (2%), application-site pruritus (1%)
Frequency not defined: Dermatologic: Skin irritation, xeroderma
Hypersensitivity to benzoyl peroxide or any other component of the formulation.
Concerns related to adverse effects:
• Bleaching effects: May bleach hair, colored fabric, or carpet.
• Hypersensitivity reaction: Rare but serious and potentially life-threatening allergic reactions or severe irritation have been reported with use of topical OTC benzoyl peroxide or salicylic acid containing products; it has not been determined if the reactions are due to the active ingredients (benzoyl peroxide or salicylic acid), the inactive ingredients, or a combination of both. Hypersensitivity reactions may occur within minutes to a day or longer after product use and differ from local skin irritation (redness, burning, dryness, itching, peeling or slight swelling) that may occur at the site of product application. Treatment should be discontinued if hives or itching develop; patients should seek emergency medical attention if reactions such as throat tightness, difficulty breathing, feeling faint, or swelling of the eyes, face, lips, or tongue develop. Before using a topical OTC acne product for the first time, consumers should apply a small amount to 1 or 2 small affected areas for 3 days to make sure hypersensitivity symptoms do not develop. (FDA Drug Safety Communication 2014).
• Photosensitivity: Use is associated with increased susceptibility/sensitivity to UV light; avoid sunlamps or excessive sunlight exposure. Daily sunscreen use and other protective measures (eg, hat) are recommended if sun exposure cannot be avoided. Discontinue use at first evidence of sunburn.
• Skin irritation: Skin irritation (eg, burning, itching, peeling, redness, swelling) may occur; discontinue use if severe irritation develops.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Concurrent drug therapy issues:
• Sulfone products: Concomitant use of benzoyl peroxide with sulfone products (eg, dapsone, sulfacetamide) may cause temporary discoloration (yellow/orange) of facial hair and skin. Application of products at separate times during the day or washing off benzoyl peroxide prior to application of other products may avoid skin discoloration (Dubina 2009).
Other warnings/precautions:
• Appropriate use: For external use only; avoid contact with eye, eyelids, lips, mouth, and mucous membranes. Inform patients to use skin protection (eg, sunscreen) and minimize prolonged exposure to sun or tanning beds.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External:
Clearskin: 10% (30 g)
Epsolay: 5% (3 g, 30 g) [contains cetyl alcohol, edetate (edta) disodium]
Foam, External:
BenzEFoam: 5.3% (100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
BenzePrO: 5.2% (60 g) [contains cetostearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
BenzePrO: 5.3% (60 g, 100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben, trolamine (triethanolamine)]
BP Foam: 5.3% (60 g [DSC], 100 g [DSC]); 9.8% (100 g [DSC]) [contains methylparaben, propylparaben]
Enzoclear: 9.8% (100 g [DSC]) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
Riax: 5.5% (100 g [DSC]); 9.5% (100 g [DSC]) [contains methylparaben, propylparaben]
Generic: 5.3% (100 g [DSC]); 9.8% (113 g)
Gel, External:
Acne Medication 2.5: 2.5% (60 g) [contains disodium edta]
Acne Medication 5: 5% (42.5 g, 60 g, 90 g [DSC]) [contains edetate (edta) disodium]
Acne Medication 10: 10% (42.5 g, 60 g) [contains edetate (edta) disodium]
Acne-Clear: 10% (42.5 g)
BP Gel: 5% (60 g [DSC]) [contains benzyl alcohol, edetate (edta) disodium, trolamine (triethanolamine)]
BP Gel: 10% (60 g [DSC]) [contains benzyl alcohol, disodium edta, trolamine (triethanolamine)]
BPO: 4% (42.5 g [DSC]); 8% (42.5 g [DSC]) [contains benzyl alcohol, cetyl alcohol]
Medpura Benzoyl Peroxide: 5% (42.5 g, 60 g, 90 g); 10% (42.5 g, 60 g, 90 g)
Generic: 2.5% (60 g); 5% (60 g, 90 g); 6.5% (113 g); 8% (113 g); 10% (56 g [DSC], 60 g, 90 g)
Kit, External:
AcneFree Acne Clearing System: Wash 2.5% and lotion 3.7% [DSC] [contains disodium edta, polysorbate 80, propylene glycol]
AcneFree Severe Clearing Syst: Wash 2.5% and lotion 10% [DSC] [contains benzalkonium chloride, butylparaben, cetyl alcohol, disodium edta, edetate (edta) sodium (tetrasodium), ethylparaben, isobutylparaben, methylisothiazolinone, methylparaben, propylene glycol, propylparaben, soybeans (glycine soja)]
Inova: Pad 4% (30s) and tocopherol 5% (28s), Pad 8% (30s) and tocopherol 5% (28s) [contains disodium edta, methylparaben]
Liquid, External:
Benzac AC Wash: 5% (226 g)
BenzePrO Creamy Wash: 7% (180 g) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Benzoyl Peroxide Cleanser: 6% (170.3 g [DSC], 340.2 g [DSC]) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Benzoyl Peroxide Wash: 5% (148 g, 237 g, 148 mL, 236 mL) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Benzoyl Peroxide Wash: 5% (142 g, 227 g) [contains edetate (edta) disodium]
Benzoyl Peroxide Wash: 10% (148 g, 237 g, 148 mL) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Benzoyl Peroxide Wash: 10% (142 g, 227 g) [contains edetate (edta) disodium]
BP Wash: 2.5% (227 g); 5% (113 g, 142 g [DSC], 227 g) [contains cetearyl alcohol, methylparaben]
BP Wash: 7% (473 mL [DSC]) [contains benzyl alcohol, cetyl alcohol, propylene glycol, trolamine (triethanolamine)]
BP Wash: 10% (142 g [DSC], 227 g) [contains cetearyl alcohol, methylparaben]
Differin Cleanser: 5% (118 mL)
Medpura Benzoyl Peroxide: 5% (148 g, 237 g); 10% (148 g, 237 g) [contains edetate (edta) disodium]
Neutrogena Clear Pore: 3.5% (125 mL) [contains disodium edta, menthol]
PanOxyl: 2.5% (156 g) [soap free; contains cetearyl alcohol]
PanOxyl Creamy Wash: 4% (170 g)
PanOxyl Foaming Wash: 10% (156 g)
PR Benzoyl Peroxide Wash: 7% (180 g, 473 mL) [contains cetyl alcohol, edetate (edta) disodium, propylene glycol]
Liquid Extended Release, External:
Advanced Acne Wash: 4.4% (104 mL)
Lotion, External:
Acne Medication 5: 5% (29.5 mL) [odorless; contains disodium edta]
Acne Medication 10: 10% (29.5 mL) [odorless; contains edetate (edta) disodium]
Zaclir Cleansing: 8% (297 g)
Miscellaneous, External:
BenzePrO Foaming Cloths: 6% (60 ea) [contains cetyl alcohol]
BPO Foaming Cloths: 6% (1 ea, 60 ea [DSC]) [contains cetostearyl alcohol, methylparaben]
May be product dependent
Cream (Clearskin External)
10% (per gram): $0.13
Cream (Epsolay External)
5% (per gram): $20.95
Foam (BenzEFoam External)
5.3% (per gram): $0.35
Foam (BenzePrO External)
5.2% (per gram): $16.69
5.3% (per gram): $13.08
Foam (Benzoyl Peroxide External)
9.8% (per gram): $9.83
Gel (Benzoyl Peroxide External)
2.5% (per gram): $0.33
5% (per gram): $0.34
6.5% (per gram): $18.00
8% (per gram): $19.95
10% (per gram): $0.35
Gel (Medpura Benzoyl Peroxide External)
5% (per gram): $0.22
10% (per gram): $0.23
Kit (Inova External)
4 & 5% (per each): $5.48
8 & 5% (per each): $5.48
Liquid (Benzac AC Wash External)
5% (per gram): $0.74
Liquid (BenzePrO Creamy Wash External)
7% (per gram): $4.60
Liquid (Differin Cleanser External)
5% (per mL): $0.07
Liquid (Medpura Benzoyl Peroxide External)
5% (per gram): $0.04
10% (per gram): $0.05
Liquid (PanOxyl Creamy Wash External)
4% (per gram): $0.05
Liquid (PanOxyl External)
2.5% (per gram): $0.05
Liquid (PanOxyl Foaming Wash External)
10% (per gram): $0.06
Liquid (PR Benzoyl Peroxide Wash External)
7% (per mL): $0.30
7% (per gram): $4.60
Misc (BenzePrO Foaming Cloths External)
6% (per each): $11.14
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Benzac W Wash10 Nettoyant: 10% (20 mL, 225 mL)
Granulation may indicate effectiveness; gels are more penetrating than creams and last longer than creams or lotions
Topical: For external use only. Avoid contact with eyes, eyelids, lips, and mucous membranes; rinse with water if accidental contact occurs. Some products may bleach or discolor hair, dyed fabrics, or carpeting; avoid contact with hair, clothing, furniture, or carpeting. Avoid unnecessary sun exposure; apply sunscreen if going outside.
Cleansers: Wet skin areas to be treated prior to administration. Rinse thoroughly and pat dry.
Cloths: Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10 to 20 seconds. Rinse thoroughly and pat dry. Throw away cloth; do not flush.
Foam: Prime can prior to initial use; refer to manufacturer’s labeling for priming instructions. Holding can upright, dispense foam into palm of hand or applicator pad and cover entire affected area and rub in until completely absorbed. Some products can remain on skin and others should be rinsed off after a brief period of time (refer to manufacturer's labeling). Rinse applicator with water and allow to dry after use; wash hands with soap and water after use.
Other dose forms: After cleansing skin, smooth small amount over affected area. If bothersome dryness or peeling occurs, reduce dose frequency or drug concentration. If excessive stinging or burning occurs after any single application, remove with mild soap and water; resume use the next day.
Topical: All products: Avoid contact with eyes and other mucous membranes. Some products may stain certain fabrics; avoid contact with clothing or furniture. May bleach hair. If bothersome dryness or peeling occurs, reduce dose frequency or drug concentration. If excessive stinging or burning occurs after any single application, remove with mild soap and water; resume use the next day.
Cleansers: Wet skin areas to be treated prior to administration. Gently massage into skin for 10 to 20 seconds, working into a full lather. Rinse thoroughly and pat dry.
Cloths: Wet face with water. Wet cloth with a little water and work into a full lather. Cleanse face with cloth for 10 to 20 seconds. Rinse thoroughly and pat dry. Throw away cloth; do not flush.
Cream (Epsolay): Prime pump until the first drop of cream is released prior to first use. Apply to each area of the face (cheek, chin, forehead, nose); avoid eyes, lips, and mouth. Avoid contact with cuts, abrasions, and eczematous or sunburned skin. Wash hands after use.
Foam: Prime can prior to initial use (refer to manufacturer's labeling for priming instructions). Shake vigorously and tap bottom of can onto palm or solid surface 3 times prior to each use. Dispense foam into palm of hand or applicator pad and cover entire affected area and rub in until completely absorbed. Some products can remain on skin and others should be rinsed off after a brief period of time (refer to manufacturers labeling). Rinse applicator with water and allow to dry after use; wash hands with soap and water after use.
Other dose forms: After cleansing skin, smooth small amount over affected area. Shake lotion well prior to use.
Store at 15°C to 30°C (59°F to 86°F).
Cream (Epsolay): Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); do not freeze. Protect from heat. Discard any portion not used after 60 days of first use.
OTC products: Treatment of acne (FDA approved in pediatric patients [age not specified] and adults). Note: Approved ages may vary by products; see product-specific labeling.
Prescription products: Treatment of mild to moderate acne vulgaris (FDA approved in ages ≥12 years and adults); treatment of inflammatory lesions of rosacea (Epsolay; FDA approved in adults); treatment of mild to moderate acne rosacea (FDA approved in adults).
Benzoyl peroxide may be confused with benzyl alcohol
Benoxyl may be confused with Brevoxyl, Peroxyl
Benzac may be confused with Benza
Brevoxyl may be confused with Benoxyl
Fostex may be confused with pHisoHex
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination
Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy
Dapsone (Topical): Benzoyl Peroxide may enhance the adverse/toxic effect of Dapsone (Topical). Specifically, the use of these agents in combination may cause skin and facial hair to temporarily turn a tan or yellow/orange color. Risk C: Monitor therapy
Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy
Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy
Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy
Animal reproduction studies have not been conducted. Topical products are recommended as initial therapy for the treatment of acne in pregnant females; benzoyl peroxide is one of the preferred agents (Chien 2016; Kong 2013; Leechman 2006).
Releases free-radical oxygen which oxidizes bacterial proteins in the sebaceous follicles decreasing the number of anaerobic bacteria and decreasing irritating-type free fatty acids
Absorption: ~5% via skin; gel more penetrating than cream
Metabolism: Converted to benzoic acid in skin
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