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

AcneFree Clear Skin Treatments by

Drug Labeling and Warnings

AcneFree Clear Skin Treatments by is a Otc medication manufactured, distributed, or labeled by Valeant Pharmaceuticals North America LLC, Universal Packaging Systems, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• ▪ have sensitive skin
• ▪ are sensitive to Benzoyl Peroxide

When using this product

• ▪ skin irritation and dryness is likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical medication at a time.
• ▪ rinse right away with water if it gets in eyes
• ▪ avoid unnecessary sun exposure and use a sunscreen
• ▪ avoid contact with the eyes, lips and mouth
• ▪ avoid product contact with hair and dyed fabrics, which may be bleached by this product
• ▪ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

skin irritation becomes severe

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.
• ▪ Clean skin thoroughly before applying this product.
• ▪ Apply to entire face, avoiding the eye area.
• ▪ Do not rinse.
• ▪ If bothersome peeling occurs, reduce application use.
• ▪ If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• ▪ 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

• ▪ have sensitive skin
• ▪ are sensitive to Benzoyl Peroxide

When using this product

• ▪ skin irritation and dryness is likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• ▪ rinse right away with water if it gets in eyes
• ▪ avoid unnecessary sun exposure and use a sunscreen
• ▪ avoid contact with eyes, lips and mouth
• ▪ avoid contact with hair and dyed fabrics, which may be bleached by this product
• ▪ skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop use and ask a doctor if

skin irritation becomes severe

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 dryness or peeling occurs, reduce application use.
• ▪ If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
• ▪ 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

Warnings

For external use only

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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

PRINCIPAL DISPLAY PANEL - Kit Carton Label

AcneFree®

CLEAR SKIN TREATMENTS

24 hour Acne Clearing System

COMPARE

TO PROACTIV®*

AMERICA’S BEST SELLING

#1

Acne Treatment In Stores†

When used as directed treats all stages of acne 24 hours a day

Some users experienced

VISIBLE RESULTS IN AS FEW AS 3 DAYS*

Advanced Micro-Benzoyl Peroxide

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

INGREDIENTS AND APPEARANCE

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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0187-1610-03	1 in 1 CARTON; Type 0: Not a Combination Product	06/25/2014

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	37 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		59 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

Part 2 of 2

24 HOUR CLEARING SYSTEM 
benzoyl peroxide liquid

Product Information
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
GLYCOLIC ACID (UNII: 0WT12SX38S)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
CHOLESTEROL (UNII: 97C5T2UQ7J)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

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

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

Labeler - Valeant Pharmaceuticals North America LLC (042230623)

Establishment
Name	Address	ID/FEI	Business Operations
Universal Packaging Systems, Inc.		790530976	MANUFACTURE(0187-1610)