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AcneFree Foam Severe Acne Pore Cleanser

Dosage form: aerosol, foam
Ingredients: Benzoyl Peroxide 5g in 100g
Labeler: University Medical Pharmaceuticals Corp
NDC Code: 50544-303

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.

AcneFree Foam Severe Acne Foam Cleanser

Active Ingredient: Benzoyl Peroxide 5% w/v

Purpose: Acne Treatment

Use for the treatment of acne.

Warnings
For external use only

Do not use if you have 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 AM and PM. Recommended: after Am use, follow with AcneFree All-Day Acne Control. After PM use, follow with AcneFree 3-in-1 Acne Night Repair.
Moisten skin.
Shake can before use.
Press down firmly on dispenser and apply a small amount of foam (not mroe than a dollop the size of a golf ball) into hand.
Using fingers, apply to face and gently massage to cleanse.
Rinse thoroughly with warm water and pat dry.
If bothersome peeling occurs, reduce application use.
If going outside, use a sunscreen.

Other information

Store at 60o-85o F (15o-30oC).
Pressurized container: Protect from sunlight and do not expose to temperatures exceeding 120oF (49oC). Do not puncture or burn, even after use. Use only as directed.

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

AcneFree Severe

Maximum Strength
Acne Pore Cleaner
Micro-Benzoyl Peroxide 5%

Rinse-Off Foam
Medicine Stays In Pore Even After Rinsing

ACNEFREE FOAM SEVERE ACNE PORE CLEANSER 
benzoyl peroxide aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-303
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
MEDIUM-CHAIN TRIGLYCERIDES 
CETYL ALCOHOL 
CHAMOMILE 
DECYL GLUCOSIDE 
DISODIUM LAURETH SULFOSUCCINATE 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
GLYCERYL MONOSTEARATE 
ISOBUTANE 
MAGNESIUM ALUMINUM SILICATE 
METHYLISOTHIAZOLINONE 
PEG-100 STEARATE 
PHENOXYETHANOL 
HIGH DENSITY POLYETHYLENE 
PROPANE 
PSEUDOPTEROGORGIA ELISABETHAE 
SODIUM BENZOATE 
STEARIC ACID 
WATER 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:50544-303-4085 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/30/201108/31/2014
Labeler - University Medical Pharmaceuticals Corp (809706252)

Revised: 05/2014
 
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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