JASON SEA FRESH ANTICAVITY SPEARMINT- sodium fluoride gel

Jason Sea Fresh Anticavity Spearmint by

Drug Labeling and Warnings

Jason Sea Fresh Anticavity Spearmint by is a Otc medication manufactured, distributed, or labeled by The Hain Celestial Group, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Fluoride 0.24%

PURPOSE

Anticavity

INDICATIONS & USAGE

use: Prevention of cavities

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION

Prevent plaque and tartar buildup with regular brushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

INACTIVE INGREDIENT

Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Titanium Dioxide, Stevia Rebaudiana Leaf/Stem Extract, Chondrus Crispus (Carrageenan), Xanthan Gum, Mentha Viridis (Spearmint) Leaf Oil, Citric Acid, Sodium Chloride, Sodium Benzoate, Menthol, Sodium Bicarbonate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JASON SEA FRESH ANTICAVITY SPEARMINT 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0601
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SPEARMINT OIL (UNII: C3M81465G5)
CARRAGEENAN (UNII: 5C69YCD2YJ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
MENTHOL, (+)- (UNII: C6B1OE8P3W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0601-1	1 in 1 CARTON	02/01/2021
1		119 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 Drug	M020	02/01/2021

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.		081512382	manufacture(61995-0601)