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

ZINC THERAPY (PYRITHIONE ZINC) LIQUID [D3 DEVELOPMENT, INC.]
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NDC 71819-007-04, 71819-007-12, 71819-007-64, 71819-007-99
Set ID 637851c6-ff4a-8bbc-e053-2991aa0a963c
Category HUMAN OTC DRUG LABEL
Packager D3 Development, Inc.
Generic Name
Product Class
Product Number
Application Number PART358H
  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

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  • PURPOSE

    Purposes

    Dandruff, Seborrheic dermatitis

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  • INDICATIONS & USAGE

    Uses

    Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.

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  • WARNINGS

    Warnings

    For external use only

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  • ASK DOCTOR

    Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.

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  • WHEN USING

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

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  • STOP USE

    Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.

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  • 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.

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  • DOSAGE & ADMINISTRATION

    Directions

    • Shake before each use
    • 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
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  • STORAGE AND HANDLING

    Other information

    • Store at room temperature
    • Lot number and expiration date can be found on the bottom of this container
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  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid

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  • QUESTIONS

    Questions?

    1-800-827-3730

    www.dermaharmony.com

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    D3 Development, Inc., Portland, ME 04101

    Made in the USA

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  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    Zinc Therapy SOAP

    2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff

    MEDICATED NATURAL CASTILE SOAP

    4 FL OZ (118 ml)

    DH ZNP 2-2-18

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  • INGREDIENTS AND APPEARANCE
    ZINC THERAPY 
    pyrithione zinc liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71819-007
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OATMEAL (UNII: 8PI54V663Y)  
    POTASSIUM OLEATE (UNII: 74WHF607EU)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71819-007-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018
    2 NDC:71819-007-12 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018
    3 NDC:71819-007-64 1893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018
    4 NDC:71819-007-99 3785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/23/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part358H 01/23/2018
    Labeler - D3 Development, Inc. (043195877)
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