ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR ACNE CLEARING SYSTEM- 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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AcneFree® Clear Skin Treatments

24 HOUR Acne Clearing System REPAIR LOTION

Drug Facts

Active ingredient

Benzoyl Peroxide 3.7% 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.

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 to entire face, avoiding the eye area. Do not rinse. If bothersome peeling occurs, reduce application use. May also be used on chest or back.

Inactive ingredients

Water, Propylene Glycol, Glycerin, Carbomer, Potassium Hydroxide, Polysorbate 80, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Disodium EDTA, Sodium Lauroyl Lactylate, Ceramide NP, Ceramide AP, Phytosphingosine, Cholesterol, Xanthan Gum, Ceramide EOP

Questions/Comments:

1-800-321-4576

24 HOUR Acne Clearing System 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

24 HOUR Acne Clearing System RENEWING TONER

Directions

Use every morning and evening. After cleansing, apply to entire face with a cotton pad, avoiding the eye area. Do not rinse. May also be used on chest or back.

Ingredients

Water, SD Alcohol, 40, Hamamelis Virginiana (Witch Hazel) Water, Sorbitol, Glycerin, Polysorbate 20, Alcohol, Glycolic Acid, Sodium Hydroxide, Aloe Barbadensis Leaf Juice, Benzalkonium Chloride, Bisabolol, Niacinamide, Panthenol, Propylene Glycol, Disodium EDTA, Chamomilla Recutita (Matricaria) Flower Extract, Copper PCA, Lactic Acid, Butylene Glycol, Methylisothiazolinone, Sea Whip Extract, Phenoxyethanol, Citric Acid, Leuconostoc/Radish Root Ferment Filtrate, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben

Questions/Comments:

1-800-321-4576

Distributed by: Valeant Consumer Products, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - Kit Carton Label

ADVANCED

FORMULA

ELIMINATES ACNE BACTERIA

AcneFree®

CLEAR SKIN TREATMENTS

24 HOUR

Acne Clearing System

Compare to

PROACTIV:

ADVANCED MICRO-BENZOYL PEROXIDE

•: Visible Results in 1-3 Days
•: Continuously Treats All Stages of Acne 24 Hours a Day

DERMATOLOGIST RECOMMENDED ACNE MEDICATION

AMERICA’S BEST SELLING

Acne Treatment In Stores†

CONTAINS: PURIFYING CLEANSER 4 FL OZ (118 mL), RENEWING TONER 4 FL OZ (118 mL), REPAIR LOTION 2FL OZ (59 mL)

AcneFree 24 HOUR Acne Clearing System Carton 1

Principal Display Panel- 24 HOUR Acne Clearing System

Principal Display Panel

AcneFree®

CLEAR SKIN TREATMENTS

Repair

Lotion

___________________

Continuous-Release

Benzoyl Peroxide

STEP

Principal Display Panel

AcneFree®

CLEAR SKIN TREATMENTS

OIL-FREE

Purifying

Cleanser

___________________

Advanced

Micro-Benzoyl Peroxide

STEP

AcneFree 24 Hour - OIL-FREE Purifying Cleanser

ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR ACNE CLEARING SYSTEM
benzoyl peroxide kit

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:0187-1610

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0187-1610-03	1 in 1 CARTON

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE	59 mL
Part 2	1 BOTTLE	118 mL

Part 1 of 2

24 HOUR CLEARING SYSTEM
benzoyl peroxide lotion

Product Information
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	5 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER
PROPYLENE GLYCOL
GLYCERIN
POTASSIUM HYDROXIDE
POLYSORBATE 80
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
EDETATE DISODIUM
SODIUM LAUROYL LACTYLATE
CERAMIDE 3
CERAMIDE 6 II
PHYTOSPHINGOSINE
CHOLESTEROL
XANTHAN GUM

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		59 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/25/2014

Part 2 of 2

24 HOUR CLEARING SYSTEM
benzoyl peroxide liquid

Product Information
Route of Administration	TOPICAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOYL PEROXIDE (BENZOYL PEROXIDE)	BENZOYL PEROXIDE	118 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		118 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/25/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	06/25/2014

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Name	Address	ID/FEI	Business Operations
Establishment
Product Quest Mfg, LLC		927768135	MANUFACTURE(0187-1610)

Revised: 6/2014

Document Id: 9e120387-6917-49a7-8080-62c63361f5c1

Set id: 9e120387-6917-49a7-8080-62c63361f5c1

Version: 1

Effective Time: 20140626

Valeant Pharmaceuticals North America LLC