Label: 111 MEDCO BENZOYL PEROXIDE- benzoyl peroxide soap
- NDC Code(s): 72811-137-11
- Packager: 111 Medco
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 12, 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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
111 MEDCO BENZOYL PEROXIDE
benzoyl peroxide soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72811-137 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 CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) SODIUM CHLORIDE (UNII: 451W47IQ8X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72811-137-11 113 g in 1 CARTON; Type 0: Not a Combination Product 04/02/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 04/02/2019 Labeler - 111 Medco (065115643)
