Indications and uses
For the treatment of acne.
For the treatment of acne.
Use once or twice daily. Morning and/or night. Apply to damp skin and Wash-In for up to 1 minute. Do not get in the eyes. For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion. Rinse off with warm water and pat dry with soft towel. If going outside, apply broad spectrum sunscreen SPF 15 or higher.
Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.
Drug Facts
Benzoyl Peroxide 3.5%
Acne Treatment
Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide, Water
Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.
Manufactured by:
Pharmco Laboratories Inc. • Titusville, FL 32780
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58400-009-01 | 2020-07-10 | C162847 | 48780-1 | 9d75b9d1-0f5d-f424-e053-dadaa90a57ce | Benzoyl Peroxide Cleanser 3.5% |
| 58400-009-02 | 2020-07-10 | C162847 | 48780-1 | 9d75b9d1-0f5d-f424-e053-dadaa90a57ce | Benzoyl Peroxide Cleanser 3.5% |
| 58400-009-01 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0f5d-f424-e053-dadaa90a57ce | Benzoyl Peroxide Cleanser 3.5% |
| 58400-009-02 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0f5d-f424-e053-dadaa90a57ce | Benzoyl Peroxide Cleanser 3.5% |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 58400-009 | 58400-009-01, 58400-009-02 |
Every source-derived ingredient row is available through these pages.
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 3dd06c63-021d-41ad-b195-4c50d65bd623 | 1a28b82b-e7da-428f-a9bf-68ef8d0db070 | 2024-12-23 | Warnings | 3dd06c63-021d-41ad-b195-4c50d65bd623 1a28b82b-e7da-428f-a9bf-68ef8d0db070 |
Adverse event summaries are temporarily unavailable. Other product information remains available.