JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT  - sodium monofluorophosphate  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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Drug Facts


Sodium Monofluorophosphate     0.76%



Anticavity


Prevention of cavities

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

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.

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.

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

             
           
image of tube label
             
image of carton label
                                     
           
                        
            
JASON SEA FRESH ANTICAVITY STRENGTHENING DEEP SEA SPEARMINT  
sodium monofluorophosphate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0104-61 in 1 CARTON
1170 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35509/20/2011
Labeler - The Hain Celestial Group, Inc. (858894996)
Establishment
NameAddressID/FEIBusiness Operations
The Hain Celestial Group, Inc.858894996manufacture

Revised: 6/2012
Document Id: ea161207-146e-4910-8512-475a3135d6b6
Set id: 8ea1e3ae-2de9-4ba6-87fc-52b535831660
Version: 1
Effective Time: 20120607
 
The Hain Celestial Group, Inc.