OIL-FREE ACNE CLEANSER - benzoyl peroxide cream 
University Medical Pharmaceuticals 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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Oil-Free Acne Cleanser

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 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 before 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:

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 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.

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

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OIL-FREE ACNE CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (benzoic acid - UNII:8SKN0B0MIM) Benzoyl Peroxide2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
glycerin (UNII: PDC6A3C0OX)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
LEVOMENOL (UNII: 24WE03BX2T)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
PSEUDOPTEROGORGIA ELISABETHAE (UNII: UDY3H1OUX5)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50544-001-06237 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/01/2011
Labeler - University Medical Pharmaceuticals Corp (809706252)
Registrant - University Medical Pharmaceuticals Corp (809706252)
Establishment
NameAddressID/FEIBusiness Operations
Universal Packaging Systems, INC177711082manufacture

Revised: 11/2011
Document Id: 038390ce-8684-4c27-98dc-9521d0e3964b
Set id: 3e284042-8054-47c3-8051-e16782bf6d8c
Version: 1
Effective Time: 20111101
 
University Medical Pharmaceuticals Corp