JASON NUTRISMILE ANTICAVITY ORANGE CINNAMON MINT - 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 cavites

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

Keep out of reach of children.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, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Daucus Carota Sativa (Carrot) Root Extract, Perilla Ocymoides Seed Extract,  Stevia Rebaudiana Leaf/Steam Extract, Citrus Aurantium Dulcis (Orange) Peel Oil, Cinnamomum Zeylancium Bark Oil, Mentha Piperita (Peppermint) Oil, Ascorbic Acid, Calcium Ascorbate, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Menthol, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Ubiquinone (2)


(1) Certified Organic Ingredients

(2) Coenzyme Q10

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

         
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JASON NUTRISMILE ANTICAVITY ORANGE CINNAMON MINT 
sodium monofluorophosphate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61995-0102
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)  
CARROT (UNII: L56Z1JK48B)  
PERILLA FRUTESCENS SEED (UNII: 8M62PUD356)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
ORANGE OIL (UNII: AKN3KSD11B)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CALCIUM ASCORBATE (UNII: 183E4W213W)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
MENTHOL (UNII: L7T10EIP3A)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
MAGNESIUM SILICATE (UNII: 9B9691B2N9)  
UBIDECARENONE (UNII: EJ27X76M46)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61995-0102-61 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: 5/2012
Document Id: ff155c43-e5a8-4546-bbfa-2623d21fb634
Set id: 08c84332-a8af-45c4-9226-efbb3eaedea3
Version: 1
Effective Time: 20120530
 
The Hain Celestial Group, Inc.