AcneFree Severe Antibacterial Cleansing Wash

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

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 Severe Antibacterial Cleansing Wash

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 after use of this product. This may increase 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 an dyed fabrics, including carpets and clothing which mat be bleached by this product.

Stop use and consult 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. If bothersome peeling occurs reduce application use. Rinse well. May also be used on chest and back.

Inactive Ingredients: 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, Polyethylene, Xanthan Gum, Cetyl Alcohol, Magnesium Aluminum Silicate, Sodium Benzoate, Caprylic/Ca[ric Triglyceride, Farnesol, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

AcneFree Severe Maximum Strength Repair Lotion Active Ingredient: Benzoyl Peroxide 10% 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 after use of this product. This mat 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 ad dyed fabrics, including carpets and clothing which may be bleached by this product.

Stop use and consult a doctor
  • If excess 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 after step 2. Apply to entire face avoiding the eye area. Do not rinse. If bothersome peeling occurs, reduce application use. May also be used on chest or back. IMPORTANT: For effective results, do not apply Steps 3 and 4 at the same time.

Inactive Ingredients: Water, Butylene Glycol, Hydroxypropyl Starch Phosphate, C12-15 Alkyl Benzoate, Glycerin, Bisabolol, Bakuchiol, Panthenyl Triacetate, Benzalkonium Chloride, Zingiber Officinale (Ginger) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Naringenin, Sea Whip Extract, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Polysorbate 60, Dimethicone, Xanthan Gum, Cetyl Alcohol, Caprylic/Capric Triglyceride, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Tetrasodium EDTA, Phenoxyethanol, Ethylhexylglycerin, Methylisothiazolinone.

AcneFree Severe Corrective Toner Directions: Use every morning and evening. After cleansing, apply to entire face, avoiding the eye area. Do not rinse. May also be used on chest or back.

Ingredients: Water/Aqua/Eau, Alcohol Denat, Hamamelis Virginiana (Witch Hazel) Water, Aloe Baradensis Leaf Juice, Sorbitol, Glycolic Acid, Glycerin, Polysorbate 20, Panthenol, Niacinamide, Lactiv Acid, Benzalkonium Chloride, Sea Whip Extract, Bisabolol, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Butylene Glycol, Propylene Glycol, Copper PCA, Sodium Hydroxide, Disodium EDTA, Methylisothiazolinone.

AcneFree Severe Retinol Renewal Complex Warnings
Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth.

Sunburn Alert
Use a sunscreen, wear protective clothing and limit sun exposure while using this product, and for a week afterwards.

Directions
 Use only at nighttime. Wait 10 minutes after applying step 2 (until skin is dry), then use fingertips to massage into acne affected areas. Do not rinse off. For effective results, do not apply Retinol Renewal Complex at the same time as step 3. Some mild tingling may occurs and should be temporary until skin adjusts. Discontinue use if skin irritation develops and lasts.

Ingredients
Water, Mineral Oil, Cetearyl Alcohol, Dimethicone, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Bisabolol, Retinol, Allantoin, Sodium Hyaluronate, Cetyl Alcohol, Allyl Methacrylates Crosspolymer,  Polysorbate 20, Xanthan Gum, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disodium EDTA, Neopentyl Glycol Dicaprylate/Dicaprate, Tridecyl Stearate, Cetyl Triethylmonium Dimethicone PEG-8 Succinate, Glycine Soja (Soybean) Sterols, Tridecyl Trimellitate, Farnesol, Phenoxyethanol, Methylparaben, Butylparaben, Ethylparaben, Propylparaben, Isobutylparaben, Methylisothiazolinone.

Severe to Clear Skin System
The ONLY TIME-RELEASED 10% Benzoyl Peroxide and Retinol System

The Most Powerful Acne-Healing Medicine Available Without A Prescription

Visible Clearing in Just Days Plus 24/7 Breakout Control
Medicine Stays in Pores to Continuously Fight Each Stage of Severe Acne
Dermatologist Tested - For All Ages and Skin Types

ACNEFREE SEVERE ANTIBACTERIAL CLEANSING WASH 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide2.5 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
DISODIUM LAURETH SULFOSUCCINATE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
STEARIC ACID 
GLYCERIN 
COCAMIDOPROPYL BETAINE 
LEVOMENOL 
BENZALKONIUM CHLORIDE 
CHAMOMILE 
PSEUDOPTEROGORGIA ELISABETHAE 
HIGH DENSITY POLYETHYLENE 
XANTHAN GUM 
CETYL ALCOHOL 
MAGNESIUM ALUMINUM SILICATE 
SODIUM BENZOATE 
MEDIUM-CHAIN TRIGLYCERIDES 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
Packaging
#Item CodePackage Description
1NDC:50544-100-941 BOTTLE (BOTTLE) in 1 KIT
1NDC:50544-100-11118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/21/2011
ACNEFREE SEVERE MAXIMUM STRENGTH REPAIR LOTION 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50544-101
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
benzoyl peroxide (benzoyl peroxide) benzoyl peroxide10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
water 
BUTYLENE GLYCOL 
ALKYL (C12-15) BENZOATE  
GLYCERIN 
LEVOMENOL 
BAKUCHIOL 
PANTHENOL TRIACETATE, (+)-  
BENZALKONIUM CHLORIDE 
GINGER 
CHAMOMILE 
NARINGENIN 
PSEUDOPTEROGORGIA ELISABETHAE 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
DIMETHICONE 
XANTHAN GUM  
CETYL ALCOHOL 
MEDIUM-CHAIN TRIGLYCERIDES  
EDETATE SODIUM 
PHENOXYETHANOL 
ETHYLHEXYLGLYCERIN 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:50544-101-941 BOTTLE (BOTTLE) in 1 KIT
1NDC:50544-101-1059 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D12/20/2011
Labeler - University Medical Pharmaceuticals Corp (809706252)
Registrant - University Medical Pharmaceuticals Corp (809706252)

Revised: 12/2011
 
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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