Label: DERMAHARMONY 10% BENZOYL PEROXIDE CLEANSING BAR- benzoyl peroxide soap

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated July 13, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzoyl peroxide 10%

  • PURPOSE

    Purpose

    Acne medication

  • INDICATIONS & USAGE

    Use

    for the management of acne

  • WARNINGS

    Warnings

    For external use only

    Do not use if 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 if irritation 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, 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: 71819-011-04

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    10% Benzoyl Peroxide

    Cleansing Bar

    FOR THE TREATMENT OF ACNE

    Reduces: pimples-blemishes-whiteheads-blackheads

    NET WT 4 OZ (113G)

    BPO=V1 Final

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY 10% BENZOYL PEROXIDE  CLEANSING BAR
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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:71819-011-04113 g in 1 CARTON; Type 0: Not a Combination Product07/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/13/2021
    Labeler - D3 Development, Inc. (043195877)
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