JASON TOTAL PROTECTION SENSITIVE- potassium nitrate paste, dentifrice

Jason Total Protection Sensitive by

Drug Labeling and Warnings

Jason Total Protection Sensitive 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

Potassium Nitrate 5%

PURPOSE

Tooth desensitizer

WARNINGS

Sensitive teeth may indicate a seriuos problem that may need prompt care by a dentist. See your dentist if the problem persists or warsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional assistance immediately.

INDICATIONS & USAGE

Tooth desensitizer

INACTIVE INGREDIENT

Calcium Carbonate, Glycerin, Water (Aqua), Xylitol, Hydrated Silica, Sodium Cocoyl Glutamate, Flavor, Eugenia Caryophyllus (Clove) Flower Oil, Mentha Piperita (Peppermint) Oil, Curcuma Longa (Turmeric) Root Extract (1), Etlingera Elatior Flower Extract, Cellulose Gum, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfate.

(1) Certified Organic Ingredient

DOSAGE & ADMINISTRATION

Potassium Nitrate 5%.

Directions: Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Children under 12 years of age: Consult a dentist or doctor.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JASON TOTAL PROTECTION SENSITIVE 
potassium nitrate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-1562
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PEPPERMINT OIL (UNII: AV092KU4JH)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CURCUMA LONGA WHOLE (UNII: W5488JUO8U)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)
SODIUM SULFATE (UNII: 0YPR65R21J)
ETLINGERA ELATIOR WHOLE (UNII: KF7S33DH97)
CLOVE OIL (UNII: 578389D6D0)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-1562-4	1 in 1 BOX	07/01/2019
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/01/2019

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(61995-1562)