JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT- sodium monofluorophosphate gel

Jason Sea Fresh Anticavity Strengthening Deep Sea Spearmint by

Drug Labeling and Warnings

Jason Sea Fresh Anticavity Strengthening Deep Sea 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 Monofluorophosphate     0.76%

PURPOSE

Anticavity

INDICATIONS & USAGE

Prevention of cavities

WARNINGS

Avoid storing at high temperatures (greater than 100°F). Protect from freezing.

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

Adults and children 2 years of age or older: brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Instruct children under 6 years of age in good brushing and rinsing habits (to monomize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6: Use a pea sized  amount. Children under 2: Ask a dentist or physician.

INACTIVE INGREDIENT

 Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Viridis (Spearmint) Leaf Oil, Aloe Barbadensis Leaf Juice (1),Aphanizomenon Flos-Aquae Powder, Bambusa Arundinacea Stem Powder, Carum Petroselinum (Parsley) Extract,Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

QUESTIONS

Questions? Call Toll Free 1-877-JASON-01 or visit www.jason-natural.com

PRINCIPAL DISPLAY PANEL

             
           

             

                                     
           
                        
            

INGREDIENTS AND APPEARANCE

JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT  
sodium monofluorophosphate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61995-0104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI)	SODIUM MONOFLUOROPHOSPHATE	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
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)
SPEARMINT OIL (UNII: C3M81465G5)
APHANIZOMENON FLOS-AQUAE (UNII: 49VG1X560X)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61995-0104-6	1 in 1 CARTON
1		170 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/20/2011

Labeler - The Hain Celestial Group, Inc. (858894996)

Establishment
Name	Address	ID/FEI	Business Operations
The Hain Celestial Group, Inc.		858894996	manufacture