ACNEFREE CLEAR SKIN TREATMENTS ADVANCED DEEP CLEANSING DUO- benzoyl peroxide   
Valeant Pharmaceuticals North America LLC

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.

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Purifying Cleanser

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 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

Preparing the Advanced Cleansing Brush for Use

Installing brush head: Press the brush head onto unit until it locks into position with a click.

Installing batteries: Remove battery cover. Insert 2 AA batteries, aligning +/- symbols. Replace batteries as needed. Do not mix old and new batteries as unit may become damaged.

Directions

Use once a day. Dampen skin, rinse brush head and pat dry to remove excess water before attaching to brush unit. Apply any AcneFree cleanser to brush head, spreading a dime-size amount evenly over brush surface; this will avoid product from splattering onto clothing while brush is in motion. (Cleansers with Benzoyl Peroxide may bleach clothing/towels.) Gently massage over face for approximately 60 seconds, concentrating on troubled areas. Avoid the eye and mouth area. Be careful not to press too hard; this will limit the motion of the brush and reduce its effectiveness. Rinse face, remove brush head, and rinse thoroughly. Recommended: For sensitive skin, use 2-3 times a week on low speed. If any slight redness occurs after use, it should fade within half an hour.

How to Care for Your Advanced Cleansing Brush

To keep your Advanced Cleansing Brush in good condition, do not use abrasive cleansers or chemicals to clean any part of the brush. Do not put any part of the Advanced Cleansing Brush unit in a dishwasher. Do not submerge the Advanced Cleansing Brush in water.

For best results: After use, remove the brush head from handle and rinse with warm soapy water to remove any residue.

Warnings

Avoid direct contact with eyes and hairline/hair. If skin irritation or redness occurs, reduce frequency of use. As this product increases exfoliation of the skin, it may also increase your skin’s sensitivity to the sun. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL – AcneFree Advanced Deep Cleansing Duo

AcneFree Advanced Deep Cleansing Duo

AcneFree®

CLEAR SKIN TREATMENTS

CLEANS 15X BETTER

Advanced

Deep Cleansing Duo

2-SPEED FACIAL CLEANSING BRUSH + OIL-FREE PURIFYING CLEANSER

Gently Deep-Cleans Pores
Clears Blackheads + Breakouts
Ultra-Soft Bristles
Waterproof

CONTAINS: 1 CLEANSING BRUSH, 2 BRUSH HEADS, 2 AA BATTERIES, CLEANSER 4 FL. OZ. (118 mL)

*then leading cleanser alone

ACNEFREE CLEAR SKIN TREATMENTS  ADVANCED DEEP CLEANSING DUO
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0187-5012
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5012-021 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 1 of 1
ACNEFREE CLEAR SKIN TREATMENTS 
benzoyl peroxide liquid
Product Information
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 DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/25/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/25/2014
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135MANUFACTURE(0187-5012)

Revised: 7/2014
 
Valeant Pharmaceuticals North America LLC