Label: MICRONIZED BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel
- NDC Code(s): 58400-001-01, 58400-001-02
- Packager: Pharmco Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 10, 2020
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- For external use only
When using this product
- Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- Avoid unnecessary sun exposure and use a sunscreen
- Avoid contact with the eyes, lips, and mouth
- Avoid contact with hair and dyed fabrics, which may be bleached by this product
- Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be erduced by using the product less frequently or in a lower concentartion.
- If going outside, apply sunscreen after using this product.
- Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- If going outside, apply broad spectrum sunscreen SPF 15 or higher.
- Other Ingredients
- Other Information
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 59 g Tube Label
INGREDIENTS AND APPEARANCE
MICRONIZED BENZOYL PEROXIDE TREATMENT
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58400-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 25 mg in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) Edetate Disodium (UNII: 7FLD91C86K) Sodium Hydroxide (UNII: 55X04QC32I) Saccharide Isomerate (UNII: W8K377W98I) CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58400-001-01 59 g in 1 TUBE; Type 0: Not a Combination Product 06/01/2012 2 NDC:58400-001-02 3900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 06/01/2012 Labeler - Pharmco Laboratories Inc. (096270814) Establishment Name Address ID/FEI Business Operations Pharmco Laboratories Inc. 096270814 MANUFACTURE(58400-001) , LABEL(58400-001) , PACK(58400-001) , ANALYSIS(58400-001)