Label: EQUATE ACNE WASH ACNE MEDICATION- benzoyl peroxide cream
- NDC Code(s): 79903-061-01
- Packager: Wal-Mart Stores, Inc.
- 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 February 10, 2023
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- Official Label (Printer Friendly)
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- Active ingredient
- Purpose
- Use
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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 or 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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Directions
- wet area to be cleansed
- apply acne wash and gently massage area for 1-2 minutes
- rinse thoroughly and pat dry
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 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 this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other information
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Inactive ingredients
water, Glycerin, decyl glucoside, sodium hydroxypropylsulfonate laurylglucoside crosspolymer, PEG-40 stearate, propanediol, sorbitan stearate, stearic acid, ammonium acryloyldimethyltaurate/VP copolymer, diethylhexyl sodium sulfosuccinate, carbomer, dimethicone, silica, sodium citrate, xanthan gum, sodium chloride, sodium hydroxide.
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 156 g Tube Carton
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INGREDIENTS AND APPEARANCE
EQUATE ACNE WASH ACNE MEDICATION
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79903-061 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 Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Decyl Glucoside (UNII: Z17H97EA6Y) SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3) PEG-40 Stearate (UNII: ECU18C66Q7) Propanediol (UNII: 5965N8W85T) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) Stearic Acid (UNII: 4ELV7Z65AP) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) DOCUSATE SODIUM (UNII: F05Q2T2JA0) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Dimethicone (UNII: 92RU3N3Y1O) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Xanthan Gum (UNII: TTV12P4NEE) Sodium Chloride (UNII: 451W47IQ8X) Sodium Hydroxide (UNII: 55X04QC32I) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:79903-061-01 1 in 1 CARTON 04/30/2021 1 156 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 04/30/2021 Labeler - Wal-Mart Stores, Inc. (051957769) Registrant - Garcoa, Inc. (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC. 255106239 MANUFACTURE(79903-061)