J1003005 JASON DANDRUFF RELIEF- sulfur, salicylic acid shampoo

J1003005 Jason Dandruff Relief by

Drug Labeling and Warnings

J1003005 Jason Dandruff Relief by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc., The Hain Celestial Group, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sulfur 2.4%

Salicylic Acid 2.2%

PURPOSE

Sulfur Controls Dandruff

Salicylic Acid Controls Seborrheic Dermatitis

INDICATIONS & USAGE

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

WARNINGS

For external use only . Avoid contact with eyes.Rinse eyes throughly with water in case contact occurs.Discontinue use and consult your physician if irritation develops.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Aqua (Water), Potassium Cocoyl Glutamate, Sodium Cocoyl Isothionate, Disodium Cocoamphodiacetate, Stearic Acid, Glycerin, Glyceryl Stearate SE, Cetyl Alcohol, Olea Europaea (Olive) Fruit Oil (1), Chenopodium Quinoa Seed (1), Rosmarinus Officinalis (Rosemary) Leaf Oil, Simmondsia Chinensis (Jojoba) Seed Oil (1), Camphor, Menthol, Methyl Salicylate, Potassium Hydroxide, Sodium PCA, Xanthan Gum, Benzyl Alcohol, Capryloyl Glycine, Sodium Chloride, Undecylenoyl Glycine, Linalool.

(1)

Certified Organic Ingredients

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

J1003005 JASON DANDRUFF RELIEF 
sulfur, salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	2.4 g  in 100 g
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CHENOPODIUM QUINOA SEED (UNII: OO4K72NZ2X)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
STEARIC ACID (UNII: 4ELV7Z65AP)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
OLIVE OIL (UNII: 6UYK2W1W1E)
ROSEMARY OIL (UNII: 8LGU7VM393)
JOJOBA OIL (UNII: 724GKU717M)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
MENTHOL (UNII: L7T10EIP3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM COCOYL GLUTAMATE (UNII: IR5T90R7LZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0030-8	355 g in 1 BOTTLE; Type 0: Not a Combination Product	11/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/27/2017

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		014334364	manufacture(61995-0030)