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ACNE THERAPY

Medically reviewed on April 24, 2017

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 30mg in 1g
Labeler: menScience Androceuticals, LLC
NDC Code: 71397-822

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.

ACNE THERAPY LOTION

Drug Facts

​Active Ingredient

Benzoyl Peroxide 3%

​Purpose

Acne Treatment

​Uses

for the treatment and prevention of acne

​Warnings

​For external use only.

Do not use:

If you have very sensitive skin or sensitive to benzoyl peroxide.

​When using this product:

Apply to affected areas only.  Avoid unnecessary sun exposure and use a sunscreen.  Do not use in or near the eyes, lips or mouth.  This product may bleach hair or dyed fabrics.  Using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin.

Discontinue use and ask a doctor

 if skin irritation becomes severe or if you are using more than one acne medication.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

​Directions:

Shake before using.  Apply to clean skin.  Cover the affected area with a thin layer 1 to 3 times daily.  Because too much drying of the skin may occur, start with 1 application daily or every other day, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.  If bothersome dryness or peeling occurs, reduce applicaction once a day or every other day.  If going outside, allow product to dry, then use a sunscreen.  Store at 20-25 ​o​C (68-77 ​o​F)

​Inactive Ingredients

Aqua purificata (purified water), C12-15 Alkyl Benzoate, Urea, Butylene Glycol, Cyclopentasiloxane, Magnesium aluminum silicated, Steareth-20, Peg-100 stearate, Zea mays (corn) starch, Hydroxyethyl acrylate/sodium acryloydimethyl, Taurate copolymer, Squalane, Polysorbate 60, Chamomilla recutita (matricaria) extract, Camellia oleifera leaf extract, Phospholipids, Retinyl palmitate, Tocopherol, Ascorbyl palmitate, Beta-carotene, Ethylhexylglycerin, Cetearyl alcohol, Glycerin, Caprylyl glycol, Dimethicone, Acrylates/C10-30 alkyl acrylate crosspolymer, Steareth-2, Butylene Glycol, Propylene glycol, Panthenol, Disodium EDTA, Allantoin, Phytonadione.

Package Labeling:

ACNE THERAPY 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71397-822
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
ALKYL (C12-15) BENZOATE 
UREA 
BUTYLENE GLYCOL 
CYCLOMETHICONE 5 
MAGNESIUM ALUMINUM SILICATE 
STEARETH-20 
PEG-100 STEARATE 
STARCH, CORN 
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) 
SQUALANE 
POLYSORBATE 60 
MATRICARIA CHAMOMILLA 
CAMELLIA OLEIFERA LEAF 
LECITHIN, SOYBEAN 
VITAMIN A PALMITATE 
TOCOPHEROL 
ASCORBYL PALMITATE 
.BETA.-CAROTENE 
ETHYLHEXYLGLYCERIN 
CETOSTEARYL ALCOHOL 
GLYCERIN 
CAPRYLYL GLYCOL 
DIMETHICONE 
STEARETH-2 
PROPYLENE GLYCOL 
PANTHENOL 
EDETATE DISODIUM ANHYDROUS 
ALLANTOIN 
PHYTONADIONE 
Packaging
#Item CodePackage Description
1NDC:71397-822-5545 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/20/2017
Labeler - menScience Androceuticals, LLC (017390110)

 
menScience Androceuticals, LLC

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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