Label: DERMAHARMONY BAR PEPPERMINT- pyrithione zinc shampoo

  • NDC Code(s): 71819-005-04, 71819-005-45
  • Packager: D3 Development, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 April 2, 2020

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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 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 directly onto hair. Massage into the hair and scalp then rinse.
  • 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, soyethyl morpholinium ethosulfate, cetearyl alcohol & ceteareth-20, sodium methyl 2 sulfolaurate & disodium 2-sulfolaurate, argan oil, oat (Avena Sativa) flour, 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. (DBA DermaHarmony), Portland, ME 04101

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

    NDC Code: 71819-005-45

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    PEPPERMINT

    Shampoo Bar with 2% Pyrithione Zinc

    FOR DANDRUFF & SEBORRHEIC DERMATITIS

    NET WT 4.5 OZ (128 G)

    Dandruff-Shampoo-Bar 20-03-30

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY BAR  PEPPERMINT
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-005
    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
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    DISODIUM 2-SULFOLAURATE (UNII: 329M3829G2)  
    OATMEAL (UNII: 8PI54V663Y)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    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)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM METHYL 2-SULFOLAURATE (UNII: I39GGJ23HV)  
    SODIUM ISETHIONATE (UNII: 3R36J71C17)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-005-45128 g in 1 CARTON; Type 0: Not a Combination Product03/24/2020
    2NDC:71819-005-04113 g in 1 CARTON; Type 0: Not a Combination Product04/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/24/2020
    Labeler - D3 Development, Inc. (043195877)
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