J1002902 JASON DANDRUFF RELIEF 2IN1 TREATMENT- pyrithione zinc shampoo
The Hain Celestial Group Inc

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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J1002902 Jason Dandruff Relief 2in1 Treatment

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

PDP

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - The Hain Celestial Group Inc (117115556)

Registrant - The Hain Celestial Group Inc (014334364)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group Inc		081512382	manufacture(61995-2439)

Revised: 10/2022

Document Id: ec0cb2ed-c09b-b37f-e053-2a95a90a64e2

Set id: 8c631014-3832-78cb-e053-2995a90a8d22

Version: 9

Effective Time: 20221027

The Hain Celestial Group Inc