FDA Label for Hismile Smooth Mint Flavor Anticavity

View Indications, Usage & Precautions

Hismile Smooth Mint Flavor Anticavity Product Label

The following document was submitted to the FDA by the labeler of this product Hismile Pty Ltd. 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 Ingredient



Sodium Fluoride 0.24%
(0.14% w/v fluoride ion)


Purpose



Anticavity


Use



aids in the prevention of dental cavities


Warnings



When using this product • do not swallow • do not use in eye area


Otc - Keep Out Of Reach Of Children



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 right away


Directions



• adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor. • instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). • supervise children as necessary until capable of using without supervision. • children under 2 years of age: Consult a dentist or doctor.


Other Information



store in a cool, dry place.


Inactive Ingredients



Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Calcium Glycerophosphate, Cellulose Gum, Xanthan Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid.


Questions Or Comments?



+1-302-440-3558
You may also report serious side effects to this phone number.


Packaging




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