Label: DERMAHARMONY BAR PEPPERMINT- salicylic acid, sulfur shampoo

  • 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 October 26, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic Acid 2%

    Sulfur 5%

  • PURPOSE

    Purpose

    Dandruff / sebhorreic dermatitis / psoriasis shampoo

  • INDICATIONS & USAGE

    Uses

    ​Helps stop the symptoms of dandruff, sebhorreic dermatitis, and psoriasis.

  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have a condition that covers a large area of the body.

  • WHEN USING

    When using this product, avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Use on affected areas in place of your regular shampoo
    • For best results use at least twice a week or as directed by a doctor
    • Rub between hands to create a lather, or apply bar directly onto hair
    • Massage into the hair and scalp for 60-90 seconds; then rinse well
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium cocoyl isethionate (SCI), stearic acid, coconut fatty acid, sodium isethionate, peppermint (Mentha Piperita) oil, coco glucoside, water, sodium methyl 2 sulfolaurate & disodium-2-sulfolaurate, cetearyl alcohol & ceteareth-20, tetrasodium glutamate diacetate, argan oil, oat (Avena Sativa) flour, sucrose cocoate, sodium isostearoyl lactylate

  • 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 71819-009-04

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    PEPPERMINT

    Shampoo Bar with Sulfur & Salicylic Acid

    FOR DANDRUFF, SEBORRHEIC DERMATITIS & PSORIASIS

    NET WT 4 OZ (113 G)

    71819-009-04

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY BAR  PEPPERMINT
    salicylic acid, sulfur shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR5 g  in 100 g
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    COCONUT ACID (UNII: 40U37V505D)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-009-04113 g in 1 CARTON; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H10/26/2020
    Labeler - D3 Development, Inc. (043195877)
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