Label: DERMAHARMONY PYRITHIONE ZINC WITH SHEA BUTTER- pyrithione zinc soap

  • 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 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

  • PURPOSE

    Purpose

    Dandruff, Seborrheic dermatitis soap

  • 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 soap
    • For best results use at least twice a week or as directed by a doctor
    • Work up a lather using warm water and massage into affected areas
    • Rinse well
  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
    • Lot number and expiration date are printed on back panel.
  • INACTIVE INGREDIENT

    Inactive ingredients

    Sodium palmate, shea butter, sodium cocoate*, sodium palm kernelate*, glycerin, water, cocoa butter, titanium dioxide, Avena Sativa (oat) kernel flour, tetrasodium glutamate diacetate, tocopheryl acetate (vitamin E), Rosmarinus officinalis (rosemary) leaf extract. *May contain this ingredient

  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in the USA

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    2% Pyrithione Zinc SOAP with Shea Butter

    For Seborrheic Dermatitis & Dandruff

    NET WT 3.7 OZ (105 G)

    71819-017 PZ with Shea Butter

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY PYRITHIONE ZINC  WITH SHEA BUTTER
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-017
    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
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOATE (UNII: R1TQH25F4I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OATMEAL (UNII: 8PI54V663Y)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-017-37105 g in 1 PACKAGE; Type 0: Not a Combination Product04/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H04/25/2022
    Labeler - D3 Development, Inc. (043195877)
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