Label: BENZOYL PEROXIDE DEEP CLEANSING FOAMING WASH- benzoyl peroxide cream
- NDC Code(s): 80861-112-01
- Packager: AcneFree, LLC
- 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 June 20, 2023
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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 sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, which may be bleached by using 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
use every morning and evening
• apply a dime-size amount to damp skin and gently massage, avoiding the eye area
• rinse well
• use wash on entire affected area one to two times daily
• because excessive drying of the skin may occur, start with washing one daily, then gradually increase to two times daily as needed, or directed by a doctor
• if bothersome dryness or peeling occurs, reduce cleansing 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.
• may be used on chest or back
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Inactive Ingredients
Water (Aqua), Glycerin, Propylene Glycol, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Sodium C14-16 Oleon Sulfonate, Xanthan Gum, Citric Acid, Potassium Hydroxide, Sodium Hyaluronate, Niacinamide, Sodium Sulfate, Avena Sativa (Oat) Kernel Extract, Sodium Lauroyl Lactylate, Glycolic Acid, Phenoxyethanol, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Carbomer, Ceramide EOP
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INGREDIENTS AND APPEARANCE
BENZOYL PEROXIDE DEEP CLEANSING FOAMING WASH
benzoyl peroxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80861-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white (cream) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-112-01 1 g in 1 TUBE; Type 0: Not a Combination Product 06/21/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M006 06/21/2023 Labeler - AcneFree, LLC (122237140) Establishment Name Address ID/FEI Business Operations Universal Packaging System, INC dba Paklab 177711082 manufacture(80861-112)
