ACNEFREE ENERGIZING ACNE CLEANSER- benzoyl peroxide liquid 
Valeant Pharmaceuticals North America LLC

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.

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Drug Facts

Active ingredient

Benzoyl Peroxide 2.5% w/v

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

When using this product

Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.
Avoid unnecessary sun exposure and use a sunscreen.
Avoid product contact with hair and dyed fabrics, including carpets and clothing which may be bleached by this product.

Do not use

If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This may cause product irritation.
Ask a doctor or pharmacist before use 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.

Stop use and ask a doctor

if excessive irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use every morning and evening. Apply a dime-size amount to damp skin and gently massage, avoiding the eye area. Rinse well. If bothersome peeling occurs, reduce application use. May also be used on chest or back.

Inactive ingredients

Water, Glycerin, Propylene Glycol, Polysorbate 20, Cocamidopropyl Hydroxysultaine, Sodium C14-16 Olefin Sulfonate, Xanthan Gum, Ceramide NP, Ceramide AP, Ceramide EOP, Menthol, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Arvensis (Cornmint) Oil, Fragrance, Microcrystalline Wax, Ethylhexyl Palmitate, Petrolatum, Citric Acid, Polyethylene, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Lauroyl Lactylate, Glycolic Acid, Phytosphingosine, Cholesterol, Carbomer, Sodium Hydroxide, Chromium Hydroxide Green, FD&C Yellow No. 5 Lake, D&C Red No. 30, Talc, Iron Oxides

acnefree.com

Distributed by: Valeant Consumer Products, a division of Valeant Pharmaceuticals North America LLC, 700 Route 202/206 North, Bridgewater, NJ 08807

Made in USA
©2013
Rev. 08/13
VNT-AFCLS-33

PRINCIPAL DISPLAY PANEL - 136 g Bottle Label

NEW
ADVANCED FORMULA
ELIMINATES ACNE BACTERIA

AcneFree®
CLEAR SKIN TREATMENTS

Energizing
Acne Cleanser

Iced Orange & Mint

2.5% Advanced Micro-Benzoyl Peroxide
Oil-Free with Exfoliating Microbeads

NET WT. 6 OZ. (170 g)

Principal Display Panel – 170 g Bottle Label
ACNEFREE  ENERGIZING ACNE CLEANSER
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-5011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide4.25 g  in 170 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CERAMIDE 3 (UNII: 4370DF050B)  
CERAMIDE 6 II (UNII: F1X8L2B00J)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
MENTHOL (UNII: L7T10EIP3A)  
ORANGE OIL (UNII: AKN3KSD11B)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PETROLATUM (UNII: 4T6H12BN9U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
TALC (UNII: 7SEV7J4R1U)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5011-05170 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/15/201407/31/2016
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-5011)

Revised: 1/2014
 
Valeant Pharmaceuticals North America LLC