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Name:Acne Cleanser
Manufacturer:University Medical Pharmaceutical Corp
Category:Over-the-counter (OTC) Marketed Drugs


ARTWORK for OIL-FREE ACNE CLEANSER 4 OZ KIT

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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ARTWORK for OIL-FREE ACNE CLEANSER 4 OZ KIT

DO NOT USE
  • IF YOU ARE SENSITIVE TO BENZOYL PEROXIDE OR HAVE VERY SENSITIVE SKIN. THIS PRODUCT MAY CAUSE IRRITATION.

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 CONTACT WITH HAIR AND DYED FABRICS, INCLUDING CARPETS AND CLOTHING WHICH MAY BE BLEACHED BY 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
  • 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.

AcneFree (R)
Clear Skin Treatments
Oil-Free
Purifying
Cleanser

Advanced
Micro-Benzoyl Peroxide

Step 1
AF 3 StepSystem Carton_C10101MECH_5-8-08-BK
AF 3 StepSystem Carton_C10101MECH_5-8-08-FR
Artwork for Purifying Cleanser Bottle



ACNE CLEANSER 
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50544-1014
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 2.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
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  
FARNESOL  
METHYLISOTHIAZOLINONE  
HIGH DENSITY POLYETHYLENE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50544-1014-3 1 BOTTLE ( BOTTLE) in 1 KIT contains a BOTTLE (50544-1014-1)
1 NDC:50544-1014-1 118 mL in 1 BOTTLE This package is contained within the KIT (50544-1014-3)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 09/28/2010

Labeler - University Medical Pharmaceutical Corp (809706252)
Registrant - University Medical Pharmaceutical Corp (809706252)
Establishment
Name Address ID/FEI Operations
Universal Packaging Systems, Inc 177711082 manufacture
Establishment
Name Address ID/FEI Operations
Micro Quality Labs Inc 149592615 analysis

Revised: 04/2011 University Medical Pharmaceutical Corp



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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