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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, Cetyl Alcohol, PPG-15 Stearyl Ether, Polyethylene, Ceramide NP, Ceramide AP, Ceramide EOP, Menthol, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Arvensis (Cornmint) Oil, Fragrance, Glycerin, Polysorbate 60, Steareth-21, C12-15 Alkyl Lactate, Neopentyl Glycol Dicaprylate/Dicaprate, Cocamidopropyl PG-Dimonium Chloride Phosphate, Microcrystalline Wax, Potassium Cetyl Phosphate, Xanthan Gum, Cetyl Lactate, Ethylhexyl Palmitate, Glycolic Acid, Petrolatum, Agar, Sodium Benzotriazolyl Butylphenol Sulfonate, Benzalkonium Chloride, Polyethylene, Disodium EDTA, Lactic Acid, Titanium Dioxide, Mica, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Sodium Lauroyl Lactylate, Phytosphingosine, Cholesterol, Carbomer, Chromium Hydroxide Green, FD&C Yello No. 5 Lake, D&C Red No. 30, Iron Oxides, Talc, BHT

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-AFSCB-76

PRINCIPAL DISPLAY PANEL - 136 g Bottle Label

NEW
ADVANCED FORMULA
ELIMINATES ACNE BACTERIA

AcneFree ®
CLEAR SKIN TREATMENTS

Energizing
Acne Wash & Scrub

Iced Orange & Mint

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

NET WT. 4.8 OZ. (136 g)

AcneFree

AcneFree

Benzoyl Peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0187-5018
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 3.4 g

Inactive Ingredients

Ingredient Name Strength
water
CETYL ALCOHOL
PPG-15 Stearyl Ether
HIGH DENSITY POLYETHYLENE
CERAMIDE 3
CERAMIDE 6 II
CERAMIDE 1
MENTHOL
ORANGE OIL
GLYCERIN
POLYSORBATE 60
STEARETH-21
C12-15 ALKYL LACTATE
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
MICROCRYSTALLINE WAX
potassium cetyl phosphate
XANTHAN GUM
Cetyl Lactate
ETHYLHEXYL PALMITATE
GLYCOLIC ACID
petrolatum
AGAR
sodium benzotriazolyl butylphenol sulfonate
benzalkonium chloride
EDETATE DISODIUM
LACTIC ACID
titanium dioxide
MICA
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
SODIUM LAUROYL LACTYLATE
phytosphingosine
CHOLESTEROL
CHROMIUM HYDROXIDE GREEN
FD&C YELLOW NO. 5
D&C RED NO. 30
ferric oxide red
talc
BUTYLATED HYDROXYTOLUENE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0187-5018-48 136 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2014-01-14


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