Label: WALGREENS ACNE FOAMING CLEANSER ACNE TREATMENT- benzoyl peroxide cream
- NDC Code(s): 0363-0467-01
- Packager: Walgreen Company
- 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 July 6, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
When using this product
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- skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time
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- avoid unnecessary sun exposure and use a sunscreen
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- avoid contact with the eyes, lips and mouth
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- avoid contact with hair and dyed fabrics, which may be bleached by this product
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- 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
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- apply a dime-size amount to damp skin and gently massage, avoiding the eye area
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- use wash on entire affected area
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- begin with one application daily then gradually increase to two times daily if needed or as directed by a doctor
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- if severe dryness or peeling occurs, reduce application to once a day or every other day
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- 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, cocamidopropyl hydroxysultaine, glycerin, sodium C14-16 olefin sulfonate, propylene glycol, xanthan gum, propanediol, diethylhexyl sodium sulfosuccinate, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, cholesterol, phenoxyethanol, phytosphingosine, disodium EDTA, ethylhexylglycerin.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton
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INGREDIENTS AND APPEARANCE
WALGREENS ACNE FOAMING CLEANSER ACNE TREATMENT
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0467 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cocamidopropyl Hydroxysultaine (UNII: 62V75NI93W) Glycerin (UNII: PDC6A3C0OX) Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U) Propylene Glycol (UNII: 6DC9Q167V3) Xanthan Gum (UNII: TTV12P4NEE) Propanediol (UNII: 5965N8W85T) DOCUSATE SODIUM (UNII: F05Q2T2JA0) Potassium Hydroxide (UNII: WZH3C48M4T) Ceramide NP (UNII: 4370DF050B) Ceramide AP (UNII: F1X8L2B00J) CERAMIDE 1 (UNII: 5THT33P7X7) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) Niacinamide (UNII: 25X51I8RD4) Glycolic Acid (UNII: 0WT12SX38S) Sodium Chloride (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Lauroyl Lactylate (UNII: 7243K85WFO) Cholesterol (UNII: 97C5T2UQ7J) Phenoxyethanol (UNII: HIE492ZZ3T) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) EDETATE DISODIUM (UNII: 7FLD91C86K) Ethylhexylglycerin (UNII: 147D247K3P) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-0467-01 1 in 1 CARTON 06/29/2021 1 150 mL 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 06/29/2021 Labeler - Walgreen Company (008965063) Registrant - Garcoa, Inc (036464697) Establishment Name Address ID/FEI Business Operations Sigan Industries INC. 255106239 MANUFACTURE(0363-0467)