Label: BPO 4%- benzoyl peroxide gel
- NDC Code(s): 42192-162-15
- Packager: Acella Pharmaceuticals 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 January 7, 2021
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- Active Ingredients
- Do not use
When using this product
- avoid unnecessary sun exposure and use sunscreen
- keep away from eyes, lips and mouth
- avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
- 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.
- Stop use and ask a doctor if
- KEEP OUT OF REACH OF CHILDREN
- 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 sunscreen after using this product. If irritation or sensitivity develops, discontinue use of product and consult a doctor.
- Other Information
- Inactive Ingredients
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42192-162 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 4 mg in 100 mg Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BENZYL ALCOHOL (UNII: LKG8494WBH) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETYL ALCOHOL (UNII: 936JST6JCN) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-162-15 42500 mg in 1 TUBE; Type 0: Not a Combination Product 01/15/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/15/2019 Labeler - Acella Pharmaceuticals LLC (825380939)