Medication Guide App

Oil-Free Acne Cleanser

Dosage form: cream
Ingredients: Benzoyl Peroxide 2.5g in 100g
Labeler: University Medical Pharmaceuticals Corp
NDC Code: 50544-001

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.

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:
  • 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 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 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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Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (benzoic acid) Benzoyl Peroxide2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
water 
DISODIUM LAURETH SULFOSUCCINATE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
STEARIC ACID 
glycerin 
COCAMIDOPROPYL BETAINE 
MATRICARIA RECUTITA 
LEVOMENOL 
BENZALKONIUM CHLORIDE 
PSEUDOPTEROGORGIA ELISABETHAE 
HIGH DENSITY POLYETHYLENE 
MAGNESIUM ALUMINUM SILICATE 
MEDIUM-CHAIN TRIGLYCERIDES 
XANTHAN GUM 
CETYL ALCOHOL 
CETYL ESTERS WAX 
SODIUM BENZOATE 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
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/FEIOperations
Universal Packaging Systems, INC177711082manufacture

Revised: 11/2011
 
University Medical Pharmaceuticals Corp

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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