Label: ACNE CLEANSING BAR- benzoyl peroxide soap
- NDC Code(s): 0363-0137-11
- Packager: Walgreens
- 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.
Drug Label Information
Updated January 24, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
For external use only
When using 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 • avoid unnecessary 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
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DOSAGE & ADMINISTRATION
Directions • using warm water, wash the affected area for 1 to 2 minutes • rinse well and pat dry with a clean towel • because too much 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, reduce application to once a day or every other day • if going outside, apply sunscreen after using the product • If irritation or sensitivity develops, stop use of both products and ask a doctor.
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients sodium cocoyl isethionate or sodium lauroyl isethionate, stearic acid, coconut acid or lauric acid, water, sodium isethionate, ethylene/VA copolymer, zea mays (corn) starch, sodium tallowate, titanium dioxide, mineral oil, cocamidopropyl betaine, tetrasodium etidronate, sodium cocoate or sodium palm kernelate, glycerin, sodium chloride, tetrasodium EDTA
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ACNE CLEANSING BAR
benzoyl peroxide soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) SODIUM LAUROYL ISETHIONATE (UNII: M590021Z02) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM TALLOWATE, BEEF (UNII: 07RIK6QMEW) COCONUT ACID (UNII: 40U37V505D) LAURIC ACID (UNII: 1160N9NU9U) WATER (UNII: 059QF0KO0R) SODIUM ISETHIONATE (UNII: 3R36J71C17) ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE) (UNII: V9BQI51YUL) STARCH, CORN (UNII: O8232NY3SJ) SODIUM COCOATE (UNII: R1TQH25F4I) SODIUM PALM KERNELATE (UNII: 6H91L1NXTW) GLYCERIN (UNII: PDC6A3C0OX) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MINERAL OIL (UNII: T5L8T28FGP) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ETIDRONATE TETRASODIUM (UNII: CZZ9T1T1X4) SODIUM CHLORIDE (UNII: 451W47IQ8X) EDETATE SODIUM (UNII: MP1J8420LU) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0137-11 113 g in 1 CARTON; Type 0: Not a Combination Product 12/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 12/01/2016 Labeler - Walgreens (008965063)
