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AcneFree

Valeant Pharmaceuticals North America LLC


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Benzoyl Peroxide 2.5% w/v

Purpose

Acne treatment

Use

For the treatment of acne.

Warnings

For external use only

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.

Do not use

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

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, Polysorbate 20, Cocamidopropyl Hydroxysultaine, Sodium C14-16 Olefin Sulfonate, Xanthan Gum, Ceramide NP, Ceramide AP, Ceramide EOP, Menthol, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Arvensis (Cornmint) Oil, Fragrance, Microcrystalline Wax, Ethylhexyl Palmitate, Petrolatum, Citric Acid, Polyethylene, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Lauroyl Lactylate, Glycolic Acid, Phytosphingosine, Cholesterol, Carbomer, Sodium Hydroxide, Chromium Hydroxide Green, FD&C Yellow No. 5 Lake, D&C Red No. 30, Talc, Iron Oxides

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
©2013
Rev. 08/13
VNT-AFCLS-33

PRINCIPAL DISPLAY PANEL - 136 g Bottle Label

NEW
ADVANCED FORMULA
ELIMINATES ACNE BACTERIA

AcneFree ®
CLEAR SKIN TREATMENTS

Energizing
Acne Cleanser

Iced Orange & Mint

2.5% Advanced Micro-Benzoyl Peroxide
Oil-Free with Exfoliating Microbeads

NET WT. 6 OZ. (170 g)

AcneFree

AcneFree

Benzoyl Peroxide LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-5011
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 4.25 g

Inactive Ingredients

Ingredient Name Strength
water
GLYCERIN
propylene glycol
POLYSORBATE 20
SODIUM C14-16 OLEFIN SULFONATE
XANTHAN GUM
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
MENTHOL
ORANGE OIL
MICROCRYSTALLINE WAX
ETHYLHEXYL PALMITATE
petrolatum
CITRIC ACID MONOHYDRATE
HIGH DENSITY POLYETHYLENE
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
SODIUM LAUROYL LACTYLATE
GLYCOLIC ACID
phytosphingosine
CHOLESTEROL
SODIUM HYDROXIDE
CHROMIUM HYDROXIDE GREEN
FD&C YELLOW NO. 5
D&C RED NO. 30
talc
ferric oxide red

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-5011-05 170 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2014-01-15


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