Label: ACNE THERAPY- benzoyl peroxide lotion

  • NDC Code(s): 71397-822-55
  • Packager: menScience Androceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • 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 ​C (68-77 ​F) ​o​o

  • ​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:

    Label

  • INGREDIENTS AND APPEARANCE
    ACNE THERAPY 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71397-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    UREA (UNII: 8W8T17847W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PHYTONADIONE (UNII: A034SE7857)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71397-822-5545 g in 1 BOTTLE; Type 0: Not a Combination Product04/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/20/2017
    Labeler - menScience Androceuticals, LLC (017390110)
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