Jason Total Protection Sensitive Toothpaste

JASON TOTAL PROTECTION SENSITIVE- potassium nitrate paste, dentifrice
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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Potassium Nitrate 5%

Tooth desensitizer

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

Tooth desensitizer

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

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.

PDP JPG

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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	07/01/2019

Labeler - The Hain Celestial Group, Inc (117115556)

Registrant - The Hain Celestial Group, Inc. (081512382)

Name	Address	ID/FEI	Business Operations
Establishment
The Hain Celestial Group, Inc		081512382	manufacture(61995-1562)