Label: ANTI BAC ACNE CLEARING- benzoyl peroxide lotion
- NDC Code(s): 43479-105-12, 43479-105-52
- Packager: KATE SOMERVILLE SKINCARE, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 12, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
-
WHEN USING
WHEN USING THIS PRODUCT
- USING OTHER TOPICAL ACNE MEDICATION AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
- AVOID CONTACT WITH EYES, LIPS, AND MOUTH.
- AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT.
- SKIN IRRITATION MY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING, OR POSSIBLE SWELLING. IRRITATION MY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
- CLEANSE SKIN THOROUGHLY BEFORE APPLYING. COVER THE AFFECTED AREA WITH A THIN LAYER 1 TO 3 TIMES A DAY. 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. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCT 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.
- OTHER INFORMATION
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INACTIVE INGREDIENTS
WATER/AQUA/EAU, PPG-2 MYRISTYL ETHER PROPIONATE, ARGANIA SPINOSA KERNEL EXTRACT, PEG-40 STEARATE, 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, PALMITIC 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:43479-105 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H) PEG-40 STEARATE (UNII: ECU18C66Q7) SAW PALMETTO (UNII: J7WWH9M8QS) SESAME SEED (UNII: 7Y1255HVXR) ALCOHOL (UNII: 3K9958V90M) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW) (UNII: XRK36F13ZZ) CARBOMER 940 (UNII: 4Q93RCW27E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE SODIUM (UNII: MP1J8420LU) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) CHOLESTEROL (UNII: 97C5T2UQ7J) CERAMIDE 2 (UNII: C04977SRJ5) CERAMIDE 3 (UNII: 4370DF050B) OLEIC ACID (UNII: 2UMI9U37CP) PALMITIC ACID (UNII: 2V16EO95H1) SODIUM ASCORBATE (UNII: S033EH8359) SODIUM HYDROXIDE (UNII: 55X04QC32I) EDETIC ACID (UNII: 9G34HU7RV0) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43479-105-52 1 in 1 BOX 06/22/2014 1 NDC:43479-105-12 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 06/22/2014 Labeler - KATE SOMERVILLE SKINCARE, LLC (615155533)
