ANTI-DANDRUFF- zinc pyrithione shampoo 
MEERAY COSMETICS CO., LTD.

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.

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Ecocare Dandruff Shampoo

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

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

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)

Revised: 2/2023
Document Id: f5b2d9f2-ff2a-2da1-e053-2995a90a68f3
Set id: f5b2d9f2-ff29-2da1-e053-2995a90a68f3
Version: 1
Effective Time: 20230227
 
MEERAY COSMETICS CO., LTD.