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AcneFree

Valeant Pharmaceuticals North America LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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

benzoyl peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-1613
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 25 mg

Inactive Ingredients

Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-1613-08 237 in 1 BOTTLE, PLASTIC
2 NDC:0187-1613-02 59 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2013-01-01


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Be sure to consult your doctor before taking any medication!
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