ACNE CLEANSER   - benzoyl peroxide lotion 
University Medical Pharmaceutical Corp

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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DO NOT USE

WHEN USING THIS PRODUCT

Water, Disodium Laureth Sulfosuccinate, Glyceryl Stearate, PEG-100 Stearate, Stearic Acid, Glycerin, Cocamidopropyl Betaine, Bakuchiol, Panthenyl Triacetate, Bisabolol, Benzalkonium Chloride, Chamomilla Recutita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Polyrthylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Capric Triglycerides, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

USE FOR THE TREATMENT OF ACNE.

ACTIVE INGREDIENT
BENZOYL PEROXIDE 2.5% W/V

PURPOSE

ACNE TREATMENT

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

WARNINGS
FOR EXTERNAL USE ONLY.

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.

STOP USE AND ASK A DOCTOR IF EXCESSIVE IRRITATION OCCURS.

ASK A DOCTOR OR PHARMACIST BEFORE USE

AcneFree
Clear Skin Treatments
Oil-Free
Acne Cleanser

Advanced
Micro-Benzoyl Peroxide

Step 1
AF CS Cleanser ART 2011-03-29 LBL_C10444-8oz


ACNE CLEANSER  
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-1014
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DISODIUM LAURETH SULFOSUCCINATE 
STEARIC ACID 
GLYCERYL MONOSTEARATE 
POLYOXYL 100 STEARATE 
GLYCERIN 
CETYL ALCOHOL 
COCAMIDOPROPYL BETAINE 
PANTHENOL 
MATRICARIA RECUTITA 
LEVOMENOL 
BENZALKONIUM CHLORIDE 
NARINGIN 
PSEUDOPTEROGORGIA ELISABETHAE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
MAGNESIUM ALUMINUM SILICATE 
SODIUM BENZOATE 
MEDIUM-CHAIN TRIGLYCERIDES 
XANTHAN GUM 
METHYLISOTHIAZOLINONE 
HIGH DENSITY POLYETHYLENE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:50544-1014-1118 mL in 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/28/201008/18/2011

Labeler - University Medical Pharmaceutical Corp (809706252)
Registrant - University Medical Pharmaceutical Corp (809706252)
Establishment
NameAddressID/FEIOperations
Universal Packaging Systems, Inc177711082manufacture
Establishment
NameAddressID/FEIOperations
Micro Quality Labs Inc149592615analysis

Revised: 08/2011 University Medical Pharmaceutical Corp