Label: DERMAHARMONY ZINC THERAPY- pyrithione zinc liquid

  • NDC Code(s): 71819-016-04, 71819-016-10, 71819-016-12, 71819-016-64, view more
    71819-016-99
  • 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 September 5, 2021

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

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

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

    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 on bottom
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Lauryl Glucoside, Cocamidopropyl Hydroxysultaine, Sodium Lauroamphoacetate, Distearyl Phthalic Acid Amide, Sodium Chloride, Lauramine Oxide, Melaleuca Alternifolia (Tea Tree) Oil, Soyethyl Morpholinium Ethosulfate, Phenoxyethanol, Aloe Barbadensis Leaf Juice

  • QUESTIONS

    Questions?

    1-800-827-3730

  • SPL UNCLASSIFIED SECTION

    Distributed by: D3 Development, Inc., Portland, ME 04101

    Made in USA from U.S. and imported ingredients

  • PRINCIPAL DISPLAY PANEL

    dermaharmony

    Zinc Therapy CLEANSER

    2% Pyrithione Zinc for Seborrheic Dermatitis & Dandruff

    HELPS STOP: FLAKING, REDNESS, IRRITATION, SCALING

    4 FL OZ (118 ml)

    71819-016 Final

  • INGREDIENTS AND APPEARANCE
    DERMAHARMONY ZINC THERAPY 
    pyrithione zinc liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71819-016
    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)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    SOYETHYL MORPHOLINIUM ETHOSULFATE (UNII: J8C5W5HH18)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71819-016-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
    2NDC:71819-016-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
    3NDC:71819-016-641893 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
    4NDC:71819-016-993785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
    5NDC:71819-016-10296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/05/2021
    Labeler - D3 Development, Inc. (043195877)
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