OTC Medication Information: Jason Nutrismile Anticavity Orange Cinnamon Mint

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.


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 Type HUMAN OTC DRUG Item Code (Source) NDC:61995-0102
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (MONOFLUOROPHOSPHATE ION ) SODIUM MONOFLUOROPHOSPHATE 0.76 g in 100 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
WATER
SILICON DIOXIDE
SODIUM COCOYL GLUTAMATE
XYLITOL
ALOE VERA LEAF
BAMBUSA ARUNDINACEA STEM
CITRUS MAXIMA SEED
CARROT
PERILLA FRUTESCENS SEED
STEVIA REBAUDIUNA LEAF
ORANGE OIL
CINNAMON BARK OIL
PEPPERMINT OIL
ASCORBIC ACID
CALCIUM ASCORBATE
CALCIUM CARBONATE
CARBOXYMETHYLCELLULOSE SODIUM
DIMETHYL SULFONE
MENTHOL
.ALPHA.-TOCOPHEROL ACETATE
SODIUM BICARBONATE
MAGNESIUM SILICATE
UBIDECARENONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61995-0102-6 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 170 g in 1 TUBE This package is contained within the CARTON (61995-0102-6)
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 Operations
The Hain Celestial Group, Inc. 858894996 manufacture

Revised: 05/2012 The Hain Celestial Group, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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