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AcneFree Oil-Free Acne Cleanser

Dosage form: liquid
Ingredients: BENZOYL PEROXIDE 25mg in 1mL
Labeler: Valeant Pharmaceuticals North America LLC
NDC Code: 0187-1613

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 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
have very sensitive skin
are sensitive to benzoyl peroxide

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 this product less frequently or in a lower concentration.

Stop use and ask a doctor if

irritation becomes severe

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
if bothersome dryness or peeling occurs, reduce application 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 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

PRINCIPAL DISPLAY PANEL – 8 FL. OZ. Bottle Label

NEW

LOOK

AcneFree®

CLEAR SKIN TREATMENTS

Oil-Free

Acne

Cleanser

Advanced

Micro-Benzoyl Peroxide

8 FL. OZ. (237 mL)

ACNEFREE  OIL-FREE ACNE CLEANSER
benzoyl peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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/FEIOperations
Ei LLC105803274MANUFACTURE(0187-1613)
Establishment
NameAddressID/FEIOperations
Universal Packaging Systems, Inc.790530976MANUFACTURE(0187-1613)

Revised: 02/2017
 
Valeant Pharmaceuticals North America LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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