Label: OIL FREE DEEP CLEANSING DUO CLEANSING BRUSH OIL FREE ACNE CLEANSER- benzoyl peroxide kit
- NDC Code(s): 80861-003-01, 80861-004-01
- Packager: AcneFree, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 27, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- 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 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. -
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 once daily, then gradually increase to two times daily if needed or as 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 -
Inactive ingredients
water, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium C14-16 olefin sulfonate, xanthan gum, citric acid, potassium hydroxide, methyl methacrylate/glycol dimethacrylate crosspolymer, sodium lauroyl lactylate, glycolic acid, ceramide NP, ceramide AP,
phytosphingosine, cholesterol, carbomer, ceramide EOP - Questions or comments?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
OIL FREE DEEP CLEANSING DUO CLEANSING BRUSH OIL FREE ACNE CLEANSER
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80861-003 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-003-01 1 in 1 KIT 08/16/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 1 of 1 OIL FREE ACNE CLEANSER
benzoyl peroxide gelProduct Information Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 25 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) XANTHAN GUM (UNII: TTV12P4NEE) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q) SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO) GLYCOLIC ACID (UNII: 0WT12SX38S) CERAMIDE NP (UNII: 4370DF050B) CERAMIDE AP (UNII: F1X8L2B00J) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) CERAMIDE 1 (UNII: 5THT33P7X7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80861-004-01 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/16/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M006 08/16/2017 Labeler - AcneFree, LLC (122237140)