ACNEFREE OIL-FREE ACNE CLEANSER- benzoyl peroxide liquid

AcneFree by

Drug Labeling and Warnings

AcneFree by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Ei LLC, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ACNEFREE  OIL-FREE ACNE CLEANSER
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0187-1613
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	NDC: 0187-1613-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2013
2	NDC: 0187-1613-02	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/01/2013

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Ei LLC		105803274	MANUFACTURE(0187-1613)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(0187-1613)