Label: DERMAHARMONY TEA TREE BAR- pyrithione zinc 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 September 29, 2022

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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 have a condition that covers a large area of the body.

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

    Stop use and ask a doctor if condition 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 finalM03209/29/2022
    Labeler - D3 Development, Inc. (043195877)
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