FDA Label for Zohar Fluoride Anti-cavity Regular Mint Flavour

View Indications, Usage & Precautions

Zohar Fluoride Anti-cavity Regular Mint Flavour Product Label

The following document was submitted to the FDA by the labeler of this product Zohar Kosher Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients



Sodium Monofluorophosphate 0.76% (0.1% w/v fluoride ion)


Purpose



Anticavity


Use



Aids in the prevention of dental cavities


Do Not Use If



irritation occurs and persists.


Keep Out Of Reach Of Children Under 6 Years Of Age.



If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Directions



 • Do not swallow • Supervise children as necessary until capable of using without supervision.

 Adults and children 2 years of age and older Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.
 Children under 6 years Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 Children under 2 years Ask a dentist or physician


Inactive Ingredients



Calcium Carbonate, Glycerin, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Spearmint Oil, Laevo Carvone, Flavor, Sodium Saccharin.


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