DANDRUFF- pyrithione zinc shampoo 
Ecocare

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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Drug Facts

Active Ingredients                                                               Purpose

Zinc Pyrithione 0.95%..............................................................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

Other Information

For external use only

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.

Do Not Use

Ask a doctor

Directions

image of label

image of label

DANDRUFF 
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46607-112
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC10.0 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DISODIUM 1-(LAURETH-2) SULFOSUCCINATE (UNII: 0A13NT4QUI)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
AMINO ACIDS, HAIR KERATIN (UNII: G46579QK1M)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PANTOTHENIC ACID (UNII: 19F5HK2737)  
SOYBEAN OIL (UNII: 241ATL177A)  
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
COCONUT OIL (UNII: Q9L0O73W7L)  
COPPER GLUCONATE (UNII: RV823G6G67)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)  
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
MANGANESE GLUCONATE (UNII: 9YY2F980SV)  
MAGNESIUM GLUCONATE (UNII: T42NAD2KHC)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
MYRTUS COMMUNIS LEAF (UNII: U20N87188F)  
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
ORANGE PEEL (UNII: TI9T76XD44)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
BETA CAROTENE (UNII: 01YAE03M7J)  
ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
SAFFLOWER (UNII: 4VBL71TY4Y)  
PRUNUS ARMENIACA LEAF (UNII: 0X5YG5R83N)  
4-METHYLPHENETHYL ALCOHOL (UNII: GG36R9LNV8)  
CLOVE LEAF OIL (UNII: VCA5491KVF)  
ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
CLIMBAZOLE (UNII: 9N42CW7I54)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
YEAST (UNII: 3NY3SM6B8U)  
sodium hydroxide (UNII: 55X04QC32I)  
ROSMARINUS OFFICINALIS FLOWER (UNII: NR1A27F29O)  
SALVIA OFFICINALIS FLOWERING TOP (UNII: 48JCS720FN)  
SUCROSE (UNII: C151H8M554)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
TRIMETHYLENEDIAMINETETRAACETIC ACID (UNII: 3F6OA94EER)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46607-112-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/29/2017
2NDC:46607-112-021000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/29/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H12/29/2017
Labeler - Ecocare (785638821)

Revised: 4/2020
Document Id: efef6fcd-24f9-4767-905b-8aefd5b353f5
Set id: 9f3de370-1f1e-4113-bc61-e70f30b5cf20
Version: 15
Effective Time: 20200407
 
Ecocare