Label: DERMAHARMONY TEA TREE BAR- pyrithione zinc shampoo

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

  • PURPOSE

    Purpose

    Dandruff / seborrheic dermatitis shampoo

  • INDICATIONS & USAGE

    Uses

    Controls and reduces the symptoms of dandruff and seborrheic dermatitis.

  • WARNINGS

    Warnings

    For external use only

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

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

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

    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, tea tree (Melaleuca Alternifolia) leaf oil, water, soyethyl morpholinium ethosulfate, coco glucoside, cetearyl alcohol & ceteareth-20, benzyl alcohol, dehydroacetic acid, oat (Avena Sativa) flour, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, sucrose cocoate, sodium isostearoyl lactylate, iron oxides (ochre).

  • 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: 71819-018-04

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    TEA TREE Shampoo Bar

    with 2% Pyrithione Zinc

    FOR DANDRUFF & SEBORRHEIC DERMATITIS

    NET WT 4 OZ (113G)

    Dandruff Shampoo 71819-018-04

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY TEA TREE BAR 
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OATMEAL (UNII: 8PI54V663Y)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    COCONUT ACID (UNII: 40U37V505D)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-018-04113 g in 1 CARTON; Type 0: Not a Combination Product09/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03209/29/2022
    Labeler - D3 Development, Inc. (043195877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vanguard Soap, LLC.831404954manufacture(71819-018)
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