Label: ZINC THERAPY- pyrithione zinc liquid

  • NDC Code(s): 71819-007-04, 71819-007-12, 71819-007-64, 71819-007-99
  • 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 January 29, 2018

If you are a consumer or patient please visit this version.

  • 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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