Label: BIBA ACNE- benzoyl peroxide gel
- NDC Code(s): 83834-001-01
- Packager: Esthetic Underground, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 13, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
When using this product
Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time
- If irritation occurs, use one topical acne medication at a time
- Avoid contact with eyes, lips & 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 reduced by using the product less frequently or in a lower concentration
- Avoid unnecessary sun exposure and use sunscreen.
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Directions
Clean the skin thoroughly before applying this product
- Cover the entire affected area with a thin layer one to three times daily
- Because excessive dryness of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor
- If bothersome dryness of peeling occurs, reduce application to once a day every other day
- Inactive Ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton
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INGREDIENTS AND APPEARANCE
BIBA ACNE
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83834-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 2.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 89.162 g in 100 mL GLYCERIN (UNII: PDC6A3C0OX) 3 g in 100 mL CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) 2.8 g in 100 mL CETEARYL GLUCOSIDE (UNII: 09FUA47KNA) 0.7 g in 100 mL PENTYLENE GLYCOL (UNII: 50C1307PZG) 0.35 g in 100 mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.3 g in 100 mL PROPANEDIOL (UNII: 5965N8W85T) 0.3 g in 100 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.3 g in 100 mL CAPRYLYL GLYCOL (UNII: 00YIU5438U) 0.15 g in 100 mL CHLORPHENESIN (UNII: I670DAL4SZ) 0.15 g in 100 mL CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.1 g in 100 mL TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) 0.074 g in 100 mL SODIUM HYDROXIDE (UNII: 55X04QC32I) 0.064 g in 100 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.05 g in 100 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83834-001-01 30 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 01/02/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH DRUG M006 01/02/2024 Labeler - Esthetic Underground, Inc. (117323900) Registrant - Product Society LLC (118666329) Establishment Name Address ID/FEI Business Operations Product Society LLC 118666329 MANUFACTURE(83834-001) , PACK(83834-001) , LABEL(83834-001)
