Label: ANTI BAC ACNE CLEARING- benzoyl peroxide lotion
- NDC Code(s): 56152-4012-1
- Packager: Cosmetic Enterprise Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 19, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
- When using this product
- Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
- Do not use this product if you have very sensitive skin or if you are sensitive to Benzoyl Peroxide.
- Avoid unnecesary 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 possible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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DOSAGE & ADMINISTRATION
Directions
- Clease Skin thoroughly before applying. Cover the affected area with a thin layer 1 to 3 days. Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor 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, stop use of products and ask a doctor.
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INACTIVE INGREDIENT
Inactive Ingredients
Water/Aqua/Eau, PPG-2 Myristyl Ether Propionate, Argania Spinosa Kernel Extract, PEG-40 Sterate, Serenoa Serrulata Fruit Extract, Sesamum Indicum (sesame) Seed Extract, Alcohol Denat., Sorbitan Stearate, Hydrogenated Methyl Abeitate, Methyl Methacrylate Crosspolymer, Carbomer, Glyceryl Stearate, Cetyl Alcohol, Tetrasodium EDTA, Hydrogenated Lecithin, Cholesterol, Ceramide NS, Ceramide NP, Oleic Acid, Plamitic Acid, Sodium Ascorbate, Sodium Hydroxide, EDTA, Ethylhexylglycerin, Phenoxyethanol
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ANTI BAC ACNE CLEARING
benzoyl peroxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:56152-4012 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength PEG-40 STEARATE (UNII: ECU18C66Q7) WATER (UNII: 059QF0KO0R) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) SERENOA REPENS WHOLE (UNII: 487DXM62F2) SESAME SEED (UNII: 7Y1255HVXR) SODIUM ASCORBATE (UNII: S033EH8359) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETIC ACID (UNII: 9G34HU7RV0) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE SODIUM (UNII: MP1J8420LU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE NS DILAURATE (UNII: 1SL625KAAV) CERAMIDE NP (UNII: 4370DF050B) OLEIC ACID (UNII: 2UMI9U37CP) PALMITIC ACID (UNII: 2V16EO95H1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:56152-4012-1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 01/14/2019 Labeler - Cosmetic Enterprise Ltd (017701475)
