Label: ZINC THERAPY- pyrithione zinc liquid

  • NDC Code(s): 71819-007-04, 71819-007-10, 71819-007-12, 71819-007-64, view more
    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 July 2, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Pyrithione zinc 2%

  • PURPOSE

    Purposes

    Dandruff, Seborrheic dermatitis

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

  • ASK DOCTOR

    Ask a doctor before use if you have seborrheic dermatitis that covers a large portion 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

    • 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
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

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

  • 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 & Anti-Dandruff

    MEDICATED NATURAL CASTILE SOAP

    4 FL OZ (118 ml)

    DH ZNP 2-2-18

  • INGREDIENTS AND APPEARANCE
    ZINC THERAPY 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-007-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    2NDC:71819-007-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    3NDC:71819-007-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    4NDC:71819-007-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/23/2018
    5NDC:71819-007-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H01/23/2018
    Labeler - D3 Development, Inc. (043195877)
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