Label: DERMAHARMONY 5% BENZOYL PEROXIDE CLEANSING BAR- benzoyl peroxide soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl peroxide 5%

  • PURPOSE

    Purpose

    Acne medication

  • INDICATIONS & USAGE

    Use

    for the management of acne

  • WARNINGS

    Warnings

    For external use only

    Do not useif you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using this product

    • avoid unnecessary sun exposure and use a sunscreen
    • avoid contact with eyes, lips and mouth
    • avoid contact with hair and dyed fabrics, which may be bleached by 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.
    • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

    Stop use and ask a doctor ifirritation becomes severe.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • using warm water, wash affected area for 1-2 minutes
    • rinse thoroughly and pat dry with a clean towel
    • start with 1 application daily, then gradually increase to 2-3 times daily if needed or as directed by a doctor
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • STORAGE AND HANDLING

    Other information

    Store in a dry place between 59-86°F (15-30°C)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium cocoyl isethionate, stearic acid, coconut fatty acid, sodium isethionate, water. coco glucoside, cetearyl alcohol & ceteareth-20, iron oxides (red and yellow), lactic acid

  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in USA of U.S. and imported ingredients.

    NDC Code: 71819-013-04

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    5% Benzoyl Peroxide

    Cleansing Bar

    FOR THE TREATMENT OF ACNE

    Reduces: pimples-blemishes-whiteheads-blackheads

    NET WT 4 OZ (113G)

    71819-013 Benzoyl Peroxide Final

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY 5% BENZOYL PEROXIDE  CLEANSING BAR
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT ACID (UNII: 40U37V505D)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-013-04113 g in 1 CARTON; Type 0: Not a Combination Product07/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/29/2021
    Labeler - D3 Development, Inc. (043195877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vanguard Soap, LLC.831404954manufacture(71819-013)
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