ZINC THERAPY (PYRITHIONE ZINC) SOAP [D3 DEVELOPMENT, INC.]

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ZINC THERAPY (PYRITHIONE ZINC) SOAP [D3 DEVELOPMENT, INC.]
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NDC 71819-001-01, 71819-001-04
Set ID 6b2de5ba-ad4b-5d43-e053-2991aa0ac3b2
Category HUMAN OTC DRUG LABEL
Packager D3 Development, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

  • 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, Avena Sativa (oat) kernel flour, olive oil, vitamin E, table salt, pentasodium pentetate

  • 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

    Zinc Therapy SOAP

    2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

    NET WT 4.0 OZ (113 G)

    Zinc Therapy Bar Final

  • INGREDIENTS AND APPEARANCE
    ZINC THERAPY 
    pyrithione zinc soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-001
    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
    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:71819-001-0128 g in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2018
    2NDC:71819-001-04113 g in 1 CELLO PACK; Type 0: Not a Combination Product05/01/2018
    3NDC:71819-001-44226 g in 1 CELLO PACK; Type 0: Not a Combination Product03/24/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H05/01/2018
    Labeler - D3 Development, Inc. (043195877)
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