Label: DERMAHARMONY 1% PYRITHIONE ZINC- 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 January 27, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 1%

  • PURPOSE

    Purpose

    Dandruff, Seborrheic dermatitis

  • 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 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, sodium cocoate*, sodium palm kernelate*, water, glycerin, titanium dioxide, table salt, olive oil, Avena Sativa (oat) kernel flour, tocopheryl acetate (vitamin E), pentasodium pentetate

    *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

    1% Pyrithione Zinc SOAP

    For Seborrheic Dermatitis & Dandruff

    NET WT 4.0 OZ (113 G)

    18197-4oz-Zinc-1Percent-Soap_V1D

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY 1% PYRITHIONE ZINC 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    SODIUM PALMATE (UNII: S0A6004K3Z)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-010-04113 g in 1 CELLO PACK; Type 0: Not a Combination Product01/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/27/2021
    Labeler - D3 Development, Inc. (043195877)
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