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, 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

1-800-321-4576

Distributed by: Valeant Consumer Products, a division of Valeant Pharmaceuticals

North America LLC, Bridgewater, NJ 08807

acnefree.com

Made in USA ©2014 Rev.02/14 9378200

PRINCIPAL DISPLAY PANEL – 8 fl. Oz. Bottle Label

ACNEFREE OIL-FREE ACNE CLEANSER (benzoyl peroxide)

ADVANCED FORMULA

ELIMINATES ACNE BACTERIA

AcneFree®

CLEAR SKIN TREATMENTS

Oil-Free

Acne

Cleanser

Gentle Exfoliating

Microbeads

NEW

CONTINOUS RELEASE

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 
GLYCERIN 
PROPYLENE GLYCOL 
COCAMIDOPROPYL HYDROXYSULTAINE 
SODIUM C14-16 OLEFIN SULFONATE 
XANTHAN GUM 
CITRIC ACID MONOHYDRATE 
POTASSIUM HYDROXIDE 
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
SODIUM LAUROYL LACTYLATE 
GLYCOLIC ACID 
CERAMIDE 3 
CERAMIDE 6 II 
PHYTOSPHINGOSINE 
CHOLESTEROL 
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: 6/2014
 
Valeant Pharmaceuticals North America LLC