ACNEFREE OIL-FREE 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.

Do not use

if you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause 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.

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.

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, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Decyl Glucoside, Polyethylene, Cetyl Alcohol, Phenoxyethanol, Xanthan Gum, Magnesium Aluminum Silicate, Sodium Benzoate, Sodium Polyacrylate, Ethylhexylglycerin, DMDM Hydantoin, Bisabolol, Methylisothiazolinone, Butylene Glycol, Sea Whip Extract, Chamomilla Recutita (Matricaria) Flower Extract, Benzalkonium Chloride, Leuconostoc/Radish Root Ferment Filtrate, Zingiber Officinale (Ginger) Root Extract, Alcohol, Methylparaben, Disodium EDTA, Ethylparaben

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

©2012

Rev. 10/12

912218

PRINCIPAL DISPLAY PANEL – 8 fl. Oz. Bottle Label

AcneFree Clear Skin Treatments Oil-Free Acne Cleanser - 8 oz Bottle Label

ADVANCED FORMULA

ELIMINATES ACNE BACTERIA

AcneFree®

CLEAR SKIN TREATMENTS

Oil-Free

Acne Cleanser

Gentle Exfoliating

Microbeads

ADVANCED

MICRO-BENZOYL PEROXIDE

8 FL. OZ. (237 mL)

ACNEFREE  OIL-FREE ACNE CLEANSER
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0187-1613
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DISODIUM LAURETH SULFOSUCCINATE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
STEARIC ACID 
GLYCERIN 
DECYL GLUCOSIDE 
HIGH DENSITY POLYETHYLENE 
CETYL ALCOHOL 
PHENOXYETHANOL 
XANTHAN GUM 
MAGNESIUM ALUMINUM SILICATE 
SODIUM BENZOATE 
ETHYLHEXYLGLYCERIN 
DMDM HYDANTOIN 
LEVOMENOL 
METHYLISOTHIAZOLINONE 
BUTYLENE GLYCOL 
PSEUDOPTEROGORGIA ELISABETHAE 
CHAMOMILE 
BENZALKONIUM CHLORIDE 
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE 
GINGER 
ALCOHOL 
METHYLPARABEN 
EDETATE DISODIUM 
ETHYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1613-08237 mL in 1 BOTTLE, PLASTIC
2NDC:0187-1613-0259 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2013
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-1613)

Revised: 5/2014
 
Valeant Pharmaceuticals North America LLC