Label: ACNEFREE CLEAR SKIN TREATMENTS ADVANCED DEEP CLEANSING DUO- benzoyl peroxide kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0187-5012-02 - Packager: Valeant Pharmaceuticals North America 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 July 16, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Use
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Warnings
For external use only.
Do not use
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- if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation.
Ask a doctor or pharmacist before use
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- if you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness, or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.
When using this product
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- Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
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- Avoid unnecessary sun exposure and use a sunscreen.
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- Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.
Stop use and ask a doctor if excessive irritation occurs.
- Directions
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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/Comments
- Preparing the Advanced Cleansing Brush for Use
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Directions
Use once a day. Dampen skin, rinse brush head and pat dry to remove excess water before attaching to brush unit. Apply any AcneFree cleanser to brush head, spreading a dime-size amount evenly over brush surface; this will avoid product from splattering onto clothing while brush is in motion. (Cleansers with Benzoyl Peroxide may bleach clothing/towels.) Gently massage over face for approximately 60 seconds, concentrating on troubled areas. Avoid the eye and mouth area. Be careful not to press too hard; this will limit the motion of the brush and reduce its effectiveness. Rinse face, remove brush head, and rinse thoroughly. Recommended: For sensitive skin, use 2-3 times a week on low speed. If any slight redness occurs after use, it should fade within half an hour.
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How to Care for Your Advanced Cleansing Brush
To keep your Advanced Cleansing Brush in good condition, do not use abrasive cleansers or chemicals to clean any part of the brush. Do not put any part of the Advanced Cleansing Brush unit in a dishwasher. Do not submerge the Advanced Cleansing Brush in water.
For best results: After use, remove the brush head from handle and rinse with warm soapy water to remove any residue.
- Warnings
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PRINCIPAL DISPLAY PANEL – AcneFree Advanced Deep Cleansing Duo
AcneFree®
CLEAR SKIN TREATMENTS
CLEANS 15X BETTER*
Advanced
Deep Cleansing Duo
2-SPEED FACIAL CLEANSING BRUSH + OIL-FREE PURIFYING CLEANSER
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- Gently Deep-Cleans Pores
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- Clears Blackheads + Breakouts
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- Ultra-Soft Bristles
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- Waterproof
CONTAINS: 1 CLEANSING BRUSH, 2 BRUSH HEADS, 2 AA BATTERIES, CLEANSER 4 FL. OZ. (118 mL)
*then leading cleanser alone
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INGREDIENTS AND APPEARANCE
ACNEFREE CLEAR SKIN TREATMENTS ADVANCED DEEP CLEANSING DUO
benzoyl peroxide kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0187-5012 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0187-5012-02 1 in 1 CARTON; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 118 mL Part 1 of 1 ACNEFREE CLEAR SKIN TREATMENTS
benzoyl peroxide liquidProduct 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 3 (UNII: 4370DF050B) CERAMIDE 6 II (UNII: F1X8L2B00J) PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q) CHOLESTEROL (UNII: 97C5T2UQ7J) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 118 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 final part333D 06/25/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/25/2014 Labeler - Valeant Pharmaceuticals North America LLC (042230623) Establishment Name Address ID/FEI Business Operations Universal Packaging Systems, Inc. 790530976 MANUFACTURE(0187-5012)