Label: ANTI-DANDRUFF- zinc pyrithione shampoo

  • NDC Code(s): 83080-121-01, 83080-121-02
  • Packager: MEERAY COSMETICS CO., LTD.
  • Category: HUMAN OTC DRUG LABEL

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 February 27, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Drug Facts

    Active Ingredients Purpose

    Zinc Pyrithione 1.00 %.........................................................Anti-Dandruff

  • Purpose

    Uses: Helps prevent recurrence of flaking and itching associated with dandruff.

  • Warnings

    FOR EXTERNAL USE ONLY

  • When using this product

    Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

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

  • Keep out of reach of children

    Keep out of reach of children

  • Dosage and Administration

    • Shake well.
    • Wet hair thoroughly.
    • Massage a liberal quantity of shampoo evenly onto the scalp and rinse. Repeat and allow to remain on the scalp for a few minutes.
    • Rinse throroughly.
    • For best results use at least twice a week or as directed by a doctor.
  • Ask a doctor

    Condition worsens or does not improve after regular use of this product as directed.

  • Do Not Use

    Condition worsens or does not improve after regular use of this product as directed.

  • Inactive Ingredients

    Aqua (Deionized Water), Decyl Glucoside, Lauryl Glucoside, Coco Glucoside, Hydrolyzed Soy Protein, Guar Hydroxypropyltrimonium Chloride, Hydrolyzed Keratin, Tocopherol, Pantothenic Acid, Saccharomyces/Selenium Ferment, Calcium Chloride, Copper Gluconate, Potassium Chloride, Managanese Gluconate, Magnesium Gluconate, Zinc Gluconate, Sodium Chloride, Olea Europaea Fruit Oil, Myrtus Comunis Oil, Lavandula Angustifolia Oil, Thymus Vulgaris Oil, Rosmarinus Officinalis Leaf Oil, Prunus Armeniaca Kernal Oil, Eugenia Caryophyllus Flower Oil, Oryza Sativa Powder, Tapioca Starch, Carica Papayan Fruit, Yeast Extract, Rosmarinus Officinalis Leaf Powder, Salvia Officinalis Leaf Extract, Sucrose, Phenethyl Alcohol, Caprylyl Glycol, Citric Acid, Tetrasodium EDTA, Essential Oils Blend

  • Indications

    Helps prevent recurrance of flaking and itching associated with dandruff.

  • Label Images

    Ecocare 10oz

    Ecocare 32oz

  • INGREDIENTS AND APPEARANCE
    ANTI-DANDRUFF 
    zinc pyrithione shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83080-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SOYBEAN OIL (UNII: 241ATL177A)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    YEAST (UNII: 3NY3SM6B8U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DISODIUM 1-(LAURETH-2) SULFOSUCCINATE (UNII: 0A13NT4QUI)  
    PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    4-METHYLPHENETHYL ALCOHOL (UNII: GG36R9LNV8)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SUCROSE (UNII: C151H8M554)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
    AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
    ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
    MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    BETA CAROTENE (UNII: 01YAE03M7J)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    PROPANEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    COPPER GLUCONATE (UNII: RV823G6G67)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)  
    CLOVE LEAF OIL (UNII: VCA5491KVF)  
    CLIMBAZOLE (UNII: 9N42CW7I54)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83080-121-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2023
    2NDC:83080-121-021000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM03203/01/2023
    Labeler - MEERAY COSMETICS CO., LTD. (688311376)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!