Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 08c84332-a8af-45c4-9226-efbb3eaedea3
Route
ORAL
Published
Effective Date 2012-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Monofluorophosphate Ion (0.76 g)
Inactive Ingredients
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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-09-20

Description

Sodium Monofluorophosphate     0.76%


Medication Information

Warnings and Precautions

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.

Indications and Usage


Prevention of cavites

Dosage and 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.

Description

Sodium Monofluorophosphate     0.76%

Section 50565-1

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

Section 51727-6

 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

Section 51945-4
         

           
            

Section 53413-1

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

Section 55105-1

Anticavity

Section 55106-9


Sodium Monofluorophosphate     0.76%






Structured Label Content

Indications and Usage (34067-9)


Prevention of cavites

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

 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

Section 51945-4 (51945-4)
         

           
            

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Anticavity

Section 55106-9 (55106-9)


Sodium Monofluorophosphate     0.76%






Advanced Ingredient Data


Raw Label Data

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