OTC Medication Information: J1003005 Jason Dandruff Relief

J1003005 JASON DANDRUFF RELIEF- sulfur and salicylic acid 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.

Sulfur 2.4%

Salicylic Acid 2.2%

Sulfur Controls Dandruff

Salicylic Acid Controls Seborrheic Dermatitis

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

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. If swallowed get medical help or contact Poison Center right away.

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

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

bottle labels
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULFUR (SULFUR) SULFUR 2.4 g in 100 g
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2.2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CHENOPODIUM QUINOA SEED
WATER
SODIUM COCOYL ISETHIONATE
DISODIUM COCOAMPHODIACETATE
STEARIC ACID
GLYCERIN
CETYL ALCOHOL
COCAMIDOPROPYL BETAINE
OLIVE OIL
ROSEMARY OIL
JOJOBA OIL
CAMPHOR (NATURAL)
MENTHOL
METHYL SALICYLATE
POTASSIUM HYDROXIDE
SODIUM PYRROLIDONE CARBOXYLATE
XANTHAN GUM
BENZYL ALCOHOL
CAPRYLOYL GLYCINE
UNDECYLENOYL GLYCINE
LINALOOL, (+/-)-
ALCOHOL
POTASSIUM COCOYL GLUTAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-0030-8 355 g in 1 BOTTLE None
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. (081512382)
Establishment
Name Address ID/FEI Operations
The Hain Celestial Group, Inc 081512382 manufacture (61995-0030)

Revised: 04/2021 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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