JASON ORAL COMFORT SENSITIVE TEETH VERY BERRY MINT- potassium nitrate gel 
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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Jason Oral Comfort Sensitive Toothpaste

Tooth desensitizer

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or a doctor.

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

Prevent plaque and tartar buildup with regular drushing. Adults and children 12 years of age or older: Apply at leasta 1-inch strip of the product onto a soft bristled toothbrush. Brush teeth throughly for at least 1 minute twice a day (morning and evevning) or as recommended by a dentist or doctor. Children under 12 years of age: consult a dentist or doctor.

Glycerin, Aqua (Water), Hydrated Silica, Sodium Cocoyl Glutamate, Xylitol, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract,Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Fragaria Vesca (Strawberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinum Angustifolium (Blueberry) Fruit Extract, Stevia Rebaudiana Leaf/Steam Extract, Eugenia Caryophyllus (Clove) Flower Oil, Mentha Pipperita (Peppermint) Oil, Menthol, Ascorbic Acid, Bambusa Arundinacea Stem Powder, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfatre, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

Use: Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets or contact.

Potassium Nitrate - 5%

carton labeltube label

JASON ORAL COMFORT SENSITIVE TEETH VERY BERRY MINT 
potassium nitrate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0535
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
RUBUS IDAEUS SUBSP. STRIGOSUS WHOLE (UNII: 68IX8867G2)  
VACCINIUM ANGUSTIFOLIUM WHOLE (UNII: R3538BZ1BW)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
CLOVE OIL (UNII: 578389D6D0)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
XYLITOL (UNII: VCQ006KQ1E)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BAMBUSA ARUNDINACEA STEM (UNII: NRA4497HC5)  
CITRUS MAXIMA SEED (UNII: 083X55C543)  
PARSLEY (UNII: 58FMD0Q0EV)  
PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
UBIDECARENONE (UNII: EJ27X76M46)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
SEA SALT (UNII: 87GE52P74G)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
THYME OIL (UNII: 2UK410MY6B)  
BEET (UNII: N487KM8COK)  
FRAGARIA VESCA WHOLE (UNII: 5J340B7H82)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0535-41 in 1 CARTON10/16/2017
1119 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/16/201710/10/2019
Labeler - The Hain Celestial Group, Inc. (117115556)
Registrant - The Hain Celestial Group, Inc. (014334364)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.081512382manufacture(61995-0535)

Revised: 2/2021
 
The Hain Celestial Group, Inc.