Label: BPO- benzoyl peroxide gel
- NDC Code(s): 42192-105-16
- Packager: Acella Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 April 4, 2013
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- Active Ingredient
- INDICATIONS & USAGE
- Keep out of reach of children.
For External Use onlyDo not use if you have very sensitive skin or if you are sensitive to benzoyl peroxide
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 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.
- 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.
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 nay occur, start with one application daily, then gradually increase to two or three times dailyif needed or as directed by a doctor
if bothersome dryness or peeling ocurs, reduce application to once a day or every other day
if going outside, apply sunscreen after using this product. If irritation or sensitivity develpos, discontinue use of product and consult a doctor
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
benzoyl peroxide gel
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42192-105 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) DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) CETYL ALCOHOL (UNII: 936JST6JCN) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42192-105-16 12 in 1 PACKAGE 1 1 in 1 CARTON 1 42500 mg in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333D 01/01/2009 Labeler - Acella Pharmaceuticals, LLC (825380939) Registrant - Ei Inc. (105803274) Establishment Name Address ID/FEI Business Operations Ei Inc. 105803274 manufacture(42192-105) , label(42192-105) , pack(42192-105)