ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE 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® Severe

24 HOUR Severe Acne Clearing System ANTI-ACNE CLEANSING WASH

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 aresensitive 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 a dime-size amount to damp skin and gently massage, avoiding the eye area. If bothersome peeling occurs, reduce application use. Rinse well. 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 Severe Acne Clearing System CORRECTIVE TONER

Drug Facts

Directions

Use every morning and evening. After cleansing, apply to entire face, 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

24 HOUR Acne Clearing System RETINOL COMPLEX

Warnings

Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

Directions

Apply only at night. Wait at least 10 minutes after applying Step 2 (until skin is dry), then use fingertips to massage into acne affected areas. Do not rinse off. For best results, do not use Retinol Complex at the same time as Step 3. Some mild tingling may occur and should be temporary until skin adjusts. Discontinue use if skin irritation develops or worsens.

Ingredients

Water, Mineral Oil, Cetearyl Alcohol, Glycerin, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Caprylic/Capric Triglyceride, Cetyl Alcohol, Phenoxyethanol, Bisabolol, Retinol, Xanthan Gum, Polysorbate 20, Allantoin, C12-15 Alkyl Benzoate, Disodium EDTA, Methylparaben, Cetyl Palmitate, Famesol, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Ceramide 3, Triethanolamine, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Cetyl Triethylmonium Dimethicone PEG-8 Succinate, Glycine Sola (Soybean) Sterols, Tridecyl Trimetlitate, Sodium Hyaluronate, Methylisothiazolinone

Questions/Comments:

1-800-321-4576

24 HOUR Acne Clearing System MAXIMUM STRENGTH REPAIR LOTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 10% 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 after Step 2. 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. IMPORTANT: For best results, do not apply Steps 3 & 4 at the same time.

Inactive Ingredients

Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Phenoxyethanol, Hydroxypropyl Starch Phosphate, Polysorbate 60, Dimethicone, Xanthan Gum, Cetyl Alcohol, Bisabolol, Tetrasodium EDTA, Ethylhexylglycerin, Methylisothiazolinone, Benzalkonium Chloride, Sea Whip Extract, Zingiber Officinale (Ginger) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Alcohol, Leuconostoc/Radish Root Ferment Filtrate, Methylparaben, Disodium EDTA, Ethylparaben, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer

Questions/Comments:

1-800-321-4576

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

acnefree.comMade in USA ©2014 Rev. 03/14 9381700

PRINCIPAL DISPLAY PANEL - Kit Carton Label

ADVANCED

FORMULA

ELIMINATES ACNE BACTERIA

AcneFree®

SEVERE

24 HOUR

Severe Acne Clearing System


PRESCRIPTION GRADE

MAXIMUM STRENGTH

Acne Medicine

ADVANCED 10% MICRO-BENZOYL PEROXIDE TREATMENT +

A RETINOL COMPLEX TO SOOTHE & RELIEVE YOUR SKIN

Visible Results in Just Days
Continuously Treats All Stages of Severe Acne 24 Hours a Day

DERMATOLOGIST RECOMMENDED ACNE MEDICATION

FROM THE MAKERS OF AMERICA’S

#1

Best-Selling Acne System In Stores†

4 PIECE SYSTEM CONTAINS: ANTI-ACNE CLEANSING WASH 4 FL OZ (118 mL), CORRECTIVE TONER 4 FL OZ (118 mL), MAXIMUM STRENGTH REPAIR LOTION 2 FL OZ (59 mL), RETINOL COMPLEX 1 OZ (28 g)

AcneFree Severe 24 HOUR Severe Acne Clearing System Carton 1

Principal Display Panel- 24 HOUR Acne Clearing System

AcneFree Severe 24 HOUR Severe Acne Clearing System Carton 2

Principal Display Panel

AcneFree®

SEVERE


Anti-Acne

Cleansing Wash

Medicated

___________________

with Advanced

Micro-Benzoyl Peroxide

STEP

1

AcneFree Severe Cleansing Wash Bottle Label

Principal Display Panel

AcneFree®

SEVERE


Maximum Strength

Repair Lotion

Continuous-Release

___________________

10% Benzoyl Peroxide

STEP

3

AcneFree Severe Max Strength Repair Lotion Bottle Label
ACNEFREE CLEAR SKIN TREATMENTS  24 HOUR SEVERE ACNE CLEARING SYSTEM
benzoyl peroxide kit
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0187-1611
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1611-041 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 59 mL
Part 1 of 2
ACNEFREE SEVERE 
benzoyl peroxide cream
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 
EDETATE DISODIUM 
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
Part 2 of 2
ACNEFREE SEVERE 
benzoyl peroxide lotion
Product Information
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETOSTEARYL ALCOHOL 
PHENOXYETHANOL 
POLYSORBATE 60 
DIMETHICONE 
XANTHAN GUM 
CETYL ALCOHOL 
LEVOMENOL 
EDETATE SODIUM 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
BENZALKONIUM CHLORIDE 
PSEUDOPTEROGORGIA ELISABETHAE 
GINGER 
CHAMOMILE 
ALCOHOL 
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE 
METHYLPARABEN 
EDETATE DISODIUM 
ETHYLPARABEN 
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
159 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(0187-1611)

Revised: 6/2014
 
Valeant Pharmaceuticals North America LLC