ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR ACNE CLEARING SYSTEM- benzoyl peroxide 
Bausch Health US 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

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)

AcneFree 24 hour Acne Clearing System - Carton
ACNEFREE CLEAR SKIN TREATMENTS  24 HOUR ACNE CLEARING SYSTEM
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0187-1610
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1610-031 in 1 CARTON; Type 0: Not a Combination Product06/25/201408/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 59 mL
Part 21 BOTTLE 118 mL
Part 1 of 2
24 HOUR CLEARING SYSTEM 
benzoyl peroxide lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE37 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/25/201408/01/2017
Part 2 of 2
24 HOUR CLEARING SYSTEM 
benzoyl peroxide liquid
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
CERAMIDE NP (UNII: 4370DF050B)  
CERAMIDE AP (UNII: F1X8L2B00J)  
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/25/201408/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/25/201408/01/2017
Labeler - Bausch Health US LLC (831922468)

Revised: 2/2017
 
Bausch Health US LLC