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

Drug Label Information

Updated December 20, 2024

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

  • 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 haveseborrheic dermatitis that covers a large portion of the body.

  • WHEN USING

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

  • STOP USE

    Stop use and ask a doctor ifcondition 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 DrugM03201/23/2018
    Labeler - D3 Development, Inc. (043195877)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vanguard Soap, LLC.831404954manufacture(71819-007)