DANDRUFF- pyrithione zinc shampoo

Dandruff by

Drug Labeling and Warnings

Dandruff by is a Otc medication manufactured, distributed, or labeled by Ecocare. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

• 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.

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

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

Ask a doctor

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

Directions

• 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 thoroughly.
• For best results use at least twice a week or as directed by a doctor.

image of label

INGREDIENTS AND APPEARANCE

DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46607-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10.0 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46607-112-01	300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/29/2017
2	NDC: 46607-112-02	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/29/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	12/29/2017

Labeler - Ecocare (785638821)