Label: DR. ZENOVIA ACNE CLEANSER- benzoyl peroxide liquid

  • NDC Code(s): 51326-803-01, 51326-803-02
  • Packager: Topiderm, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 10.0%

  • Purpose

    Acne Treatment

  • Uses

    • For the treatment and management of acne
    • Penetrates pores to eliminate most acne and blemishes
    • Helps prevent development of new acne blemishes and blackheads
  • Warnings

    For external use only

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • Avoid contact with eyes. If contact occurs, flush thoroughly with water.

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pump a small amount of cleanser into dampened hands, and gently massage over face and neck using a circular motion.
    • Rinse thoroughly with water and pat dry.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Bakuchiol, Camellia Sinensis (Green Tea) Leaf Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Fragrance, Genistein, Glycerin, Maltodextrin, Phenoxyethanol, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP, Tocopheryl Acetate.

  • Questions?

    Call (800) 445-2595 or visit drzenovia.com

  • REG-ulate360 Active Complex™

    Resveratrol, Bakuchiol, Genistein, Camellia Sinensis (Green Tea) Polyphenols, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract.

  • SPL UNCLASSIFIED SECTION

    Distributed by Dr. Zenovia Skincare
    Babylon, NY 11704

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    DR. ZENOVIA
    HORMONAL DERMATOLOGY

    CLEAR COMPLEXION

    10% BENZOYL PEROXIDE
    ACNE CLEANSER

    reg-ulate360 complex™,
    aloe vera, antioxidants

    removes excess sebum,
    impurities and buildup

    120 mL / 4.0 Fl. Oz.

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DR. ZENOVIA ACNE CLEANSER 
    benzoyl peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51326-803
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CUCUMBER JUICE (UNII: 61845009SP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)  
    WATER (UNII: 059QF0KO0R)  
    RESVERATROL (UNII: Q369O8926L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    GENISTEIN (UNII: DH2M523P0H)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51326-803-011 in 1 BOX06/11/2024
    1120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:51326-803-021 in 1 BOX07/25/2024
    250 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00606/11/2024
    Labeler - Topiderm, Inc. (049121643)
    Registrant - Topiderm, Inc. (049121643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Topiderm, Inc.049121643MANUFACTURE(51326-803)
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