J1002902 JASON DANDRUFF RELIEF 2IN1 TREATMENT- pyrithione zinc shampoo

J1002902 Jason Dandruff Relief 2in1 Treatment by

Drug Labeling and Warnings

J1002902 Jason Dandruff Relief 2in1 Treatment by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Act Ingred - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Active Ingredient:

Zinc Pyrithione 1.0%

KOORC - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Warnings:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Purpose:

Controls dandruff

D&A - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Directions:

For best results use at least three times each week. Wet hair and lather, massage onto scalp. Rinse and repeat if desired.

Warnings - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Warnings.

For external use only. Avoid contact with eyes. Rinse eyes thoroughly with water in case contact occurs. Discontinue use and consult your physician if irritation develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indication & Use - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Uses:

• Controls recurrance of flaking, scaling, and itching associated with dandruff
• Helps prevent seborrheic dermatitis

Inactives - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

Inactive ingredients:

Water (Aqua), Sodium Cocoyl Isethionate, Cetyl Alcohol, Glycerin, Cocamidopropyl Hydroxysultaine, Sodium Laurylglucosides Hydroxypropylsulfonate, Sodium Cocoyl Glutamate, Sodium Chloride, Glyceryl Stearate SE, Coco-Glucoside, Glyceryl Oleate, Butyrospermum Parkii (Shea) Butter Unsaponifiables, Citrus Aurantium Dulcis (Orange) Peel Oil, Olea Europaea (Olive) Fruit Oil (1), Simmondsia Chinensis (Jojoba) Seed Oil (1), Soybean Glycerides, Chenopodium Quinoa Seed (1), Ascorbyl Palmitate, Babassu Oil Polyglyceryl-4 Esters, Benzyl Acetate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cellulose Gum, Citric Acid, Diheptyl Succinate, Guar Hydroxypropyltrimonium Chloride, Phenethyl Alcohol, Sodium Hydroxide, Sodium PCA, Terpineol, Triethyl Citrate, Xanthan Gum, Zinc Carbonate, Alcohol (1), Ethylhexylglycerin, Phenoxyethanol, Potassium Sorbate, Limonene, Linalool.

PDP - Jason Dandruff Relief Treatment 2-in-1 Shampoo & Conditioner

INGREDIENTS AND APPEARANCE

J1002902 JASON DANDRUFF RELIEF 2IN1 TREATMENT 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-2439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)	4.7 g  in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1.4 g  in 100 g
CETYL ALCOHOL (UNII: 936JST6JCN)	5 g  in 100 g
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)	5 g  in 100 g
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)	2 g  in 100 g
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)	1.2 g  in 100 g
WATER (UNII: 059QF0KO0R)	66.7 g  in 100 g
GLYCERIN (UNII: PDC6A3C0OX)	5 g  in 100 g
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)	3 g  in 100 g
DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)	1.5 g  in 100 g

Product Characteristics
Color	white	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-2439-8	355 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	06/26/2019

Labeler - The Hain Celestial Group Inc (117115556)

Registrant - The Hain Celestial Group Inc (014334364)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group Inc		117115556	manufacture(61995-2439)