Overview
Benzoyl peroxide is a commonly used drug in topical treatments for acne. It has been formulated as products with either a single active ingredient, or with erythromycin, clindamycin, or adapalene. After administration, the peroxide bond is cleaved, allowing benzoyloxy radicals to nonspecifically interact with proteins. This treatment decreases keratin and sebum around follicles, as well as increasing turnover of epithelial cells. Benzoyl peroxide, in combination with erythromycin, was granted FDA approval on 26 October 1984.
Indication
Benzoyl peroxide is formulated with antibiotics such as erythromycin and clindamycin for the treatment of acne vulgaris. Benzoyl peroxide is formulated as a number of topical products for the treatment of acne. Benzoyl peroxide is also indicated in combination with tretinoin for the treatment of acne vulgaris in patients aged nine years and older. A triple-combination therapy including both clindamycin and adapalene is also available and indicated for the treatment of acne vulgaris in patients ≥12 years of age. Topical benzoyl peroxide is also indicated for the treatment of inflammatory lesions of rosacea in adults.
Associated Conditions
- Acne
- Acne Vulgaris
- Inflammatory Acne Vulgaris
- Inflammatory lesions caused by rosacea
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2008/04/22 | Phase 3 | Completed | Dow Pharmaceutical Sciences | ||
2008/04/22 | Phase 3 | Completed | Dow Pharmaceutical Sciences | ||
2008/04/14 | Phase 4 | Completed | |||
2007/11/15 | Not Applicable | Completed | |||
2007/03/12 | Phase 3 | Completed | |||
2007/01/15 | Phase 3 | Completed | |||
2007/01/15 | Phase 3 | Completed | |||
2005/09/12 | Phase 4 | Completed | Stiefel, a GSK Company |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Lifesciences Limited | 70771-1450 | TOPICAL | 50 mg in 1 g | 8/4/2022 | |
| Bausch Health US, LLC | 0187-3050 | TOPICAL | 37.5 mg in 1 g | 7/23/2025 | |
| DR. THROWER'S SKINCARE, INC. | 69299-103 | TOPICAL | 5 g in 100 g | 5/22/2015 | |
| GABAR HEALTH SCIENCES CORP | 82429-313 | TOPICAL | 25 mg in 1 g | 1/29/2024 | |
| Bryant Ranch Prepack | 63629-9322 | TOPICAL | 25 mg in 1 g | 6/2/2022 | |
| Bryant Ranch Prepack | 63629-8635 | TOPICAL | 25 mg in 1 g | 7/17/2023 | |
| Bausch Health US LLC | 0187-0006 | TOPICAL | 31 mg in 1 g | 11/7/2023 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-859 | TOPICAL | 50 mg in 1 g | 8/31/2021 | |
| Galderma Laboratories, L.P. | 0299-5890 | TOPICAL | 50 mg in 1 g | 4/20/2023 | |
| Mayne Pharma Commercial LLC | 51862-771 | TOPICAL | 30 mg in 1 g | 8/11/2025 |
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| No EMA approvals found for this drug. | |||
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| No HSA approvals found for this drug. | |||||
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Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| BENZAC W 5 GEL 5% | galderma canada inc | 01925180 | Gel - Topical | 5 % | 12/31/1980 |
| BENOXYL | 00370568 | Lotion - Topical | 10 % | 12/31/1976 | |
| STUBBORN ACNE SPOT GEL | johnson & johnson inc | 02440512 | Gel - Topical | 5 % / W/W | 1/18/2016 |
| REDNESS RELIEF NEUTRALIZING LOTION | university medical pharmaceutical corp | 02318644 | Lotion - Topical | 3 % / W/W | N/A |
| REPLENIX ACNE | TOPIX PHARMACEUTICALS INC | 02488272 | Solution - Topical | 5 % / W/W | N/A |
| PURIFYING CLEANSER | valeant canada lp / valeant canada s.e.c. | 02315211 | Solution - Topical | 2.5 % / W/W | 2/9/2009 |
| PROACTIV+ 3 PIECE SET | 02414422 | Gel
,
Kit - Topical | 2.5 % / W/W | 6/20/2014 | |
| PURE PERFECTION CLASSIC RENEWING CREME | koolatron corporation | 02247943 | Cream - Topical | 2.5 % | 10/25/2003 |
| BENZAC ACNE GEL 2.5% | galderma canada inc | 02529246 | Gel - Topical | 2.5 % / W/W | N/A |
| CLEARASIL DAILY CLEAR ACNE TREATMENT CREAM BP PLUS | reckitt benckiser (canada) inc | 00442968 | Cream - Topical | 5 % / W/W | 12/31/1982 |
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