Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Bar, External:
PanOxyl: 10% (1 ea [DSC])
Cream, External:
Clearskin: 10% (30 g)
Foam, External:
BenzEFoam: 5.3% (60 g [DSC], 100 g [DSC]) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
BenzEFoamUltra: 9.8% (100 g [DSC]) [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)]
BenzePrO Short Contact: 9.8% (100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
BP Foam: 5.3% (60 g [DSC], 100 g [DSC]); 9.8% (100 g [DSC]) [contains methylparaben, propylparaben]
Enzoclear: 9.8% (100 g) [contains cetearyl alcohol, disodium edta, methylparaben, propylene glycol, propylparaben]
Riax: 5.5% (100 g); 9.5% (100 g) [contains methylparaben, propylparaben]
Generic: 5.3% (60 g [DSC], 100 g); 9.8% (100 g [DSC], 113 g)
Gel, External:
Acne Medication 5: 5% (42.5 g) [contains edetate disodium]
Acne Medication 10: 10% (42.5 g) [contains edetate disodium]
Acne-Clear: 10% (42.5 g)
Benziq: 5.25% (50 g) [contains benzyl alcohol, disodium edta, trolamine (triethanolamine)]
Benziq LS: 2.75% (50 g) [contains trolamine (triethanolamine)]
BP Gel: 5% (60 g) [contains benzyl alcohol, edetate disodium, trolamine (triethanolamine)]
BP Gel: 5.5% (60 g [DSC]); 10% (60 g) [contains benzyl alcohol, disodium edta, trolamine (triethanolamine)]
BPO: 4% (42.5 g); 8% (42.5 g) [contains benzyl alcohol, cetyl alcohol]
Clearplex V: 5% (45 g [DSC])
Clearplex X: 10% (45 g [DSC])
OC8: 7% (45 g [DSC]) [contains disodium edta, propylene glycol]
PanOxyl: 3% (10 g [DSC]) [contains disodium edta]
Generic: 2.5% (60 g); 5% (60 g, 90 g); 6.5% (113 g); 8% (113 g); 10% (56 g, 60 g, 90 g)
Kit, External:
AcneFree Acne Clearing System: Wash 2.5% and lotion 3.7% [contains disodium edta, polysorbate 80, propylene glycol]
AcneFree Severe Clearing Syst: Wash 2.5% and lotion 10% [contains benzalkonium chloride, butylparaben, cetyl alcohol, disodium edta, edetate sodium (tetrasodium), ethylparaben, isobutylparaben, methylisothiazolinone, methylparaben, propylene glycol, propylparaben, soybeans (glycine max)]
BPO Creamy Wash: Wash 4% (170.1 g) and bar soap 5% (2 x 21 g) [DSC], Wash 8% (170.1 g) and bar soap 5% (2 x 21 g) [DSC] [contains disodium edta, methylparaben]
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 disodium, propylene glycol]
Benziq Wash: 5.25% (175 g) [contains benzyl alcohol, cetyl alcohol, disodium edta, propylene glycol]
Benzoyl Peroxide Cleanser: 6% (170.3 g, 340.2 g) [contains cetyl alcohol, edetate disodium, propylene glycol]
Benzoyl Peroxide Wash: 5% (148 g, 237 g) [contains cetyl alcohol, edetate disodium, propylene glycol]
Benzoyl Peroxide Wash: 5% (142 g, 227 g) [contains edetate disodium]
Benzoyl Peroxide Wash: 10% (148 g, 237 g) [contains cetyl alcohol, edetate disodium, propylene glycol]
Benzoyl Peroxide Wash: 10% (142 g, 227 g) [contains edetate disodium]
BP Foaming Wash: 10% (227 g [DSC]) [contains cetearyl alcohol, methylparaben]
BP Wash: 2.5% (227 g); 5% (113 g, 142 g, 227 g) [contains cetearyl alcohol, methylparaben]
BP Wash: 7% (473 mL) [contains benzyl alcohol, cetyl alcohol, propylene glycol, trolamine (triethanolamine)]
BP Wash: 10% (142 g, 227 g) [contains cetearyl alcohol, methylparaben]
BPO-10 Wash: 10% (227 g [DSC]) [contains methylparaben, propylene glycol, propylparaben]
BPO-5 Wash: 5% (227 g [DSC]) [contains methylparaben, propylene glycol, propylparaben]
Desquam-X Wash: 5% (140 g [DSC]); 10% (140 g [DSC]) [contains edetate 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)
PanOxyl Wash: 10% (156 g [DSC]) [contains alcohol, usp, methylparaben]
PanOxyl-4 Creamy Wash: 4% (170 g [DSC]) [contains cetearyl alcohol, methylparaben]
PR Benzoyl Peroxide Wash: 7% (180 g, 473 mL) [contains cetyl alcohol, edetate 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 disodium]
Benzoyl Peroxide Cleanser: 3% (340.2 g [DSC]); 9% (340.2 g [DSC]) [contains cetyl alcohol, edetate disodium, propylene glycol]
Oscion Cleanser: 6% (170.3 g [DSC], 340.2 g [DSC])
Zaclir Cleansing: 8% (297 g)
Miscellaneous, External:
BenzePrO Foaming Cloths: 6% (60 ea) [contains cetyl alcohol]
BPO Foaming Cloths: 6% (60 ea) [contains methylparaben]
Pharmacology
Mechanism of Action
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
Pharmacokinetics/Pharmacodynamics
Absorption
~5% via skin; gel more penetrating than cream
Metabolism
Converted to benzoic acid in skin
Use: Labeled Indications
Acne vulgaris, acne rosacea: Treatment of mild to moderate acne vulgaris and acne rosacea
Contraindications
Hypersensitivity to benzoyl peroxide or any other component of the formulation.
Dosage and Administration
Dosing: Adult
Acne:
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.
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Acne: Children ≥7 years and Adolescents (Eichenfield 2013): Limited data available in ages <12 years: 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
Administration
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.
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.
Storage
Store at 15°C to 30°C (59°F to 86°F).
Drug Interactions
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. Monitor therapy
Isotretinoin (Topical): Benzoyl Peroxide may diminish the therapeutic effect of Isotretinoin (Topical). Consider therapy modification
Adverse Reactions
1% to 10%: Dermatologic: Desquamation (≤5%), erythema (≤5%), contact dermatitis (1% to 3%)
Frequency not defined: Dermatologic: Skin irritation, xeroderma
Warnings/Precautions
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).
- 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.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
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).
Patient Education
What is this drug used for?
- It is used to treat pimples (acne).
Frequently reported side effects of this drug
- Dry skin
- Skin irritation
- Itching
- Peeling
- Sensation of warmth
Other side effects of this drug: Talk with your doctor right away if you have:
- Signs of a significant reaction like wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
