Label: HUMANE ACNE WASH- benzoyl peroxide liquid
- NDC Code(s): 73010-900-00
- Packager: Apprendista, LLC
- 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.
Updated June 4, 2019
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- Drug Facts
- Active ingredient
For external use only.
Do not use
- If you are sensitive to Benzoyl Peroxide or have very sensitive skin.
- Using other topical acne drugs at the same time or right after use of this product may increase dryness, redness or irritation of the skin.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
When using this product
- Avoid contact with and near eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
- Avoid unnecessary sun exposure and use a sunscreen.
- Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
- Inactive ingredients
- Package Labeling:
INGREDIENTS AND APPEARANCE
HUMANE ACNE WASH
benzoyl peroxide liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73010-900 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLUCONOLACTONE (UNII: WQ29KQ9POT) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73010-900-00 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 04/01/2019 Labeler - Apprendista, LLC (116995922)