FDA Label for Hismile
View Indications, Usage & Precautions
Hismile 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.
Otc - Active Ingredient
Active ingredient
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Otc - Purpose
Purpose
Anticavity
Indications & Usage
Use
Aids in the prevention of dental cavities
Warnings
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.
Dosage & Administration
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.
Inactive Ingredient
Water
Sorbitol
Glycerin
Hydrated Silica
Xylitol
Flavor
Sodium Methyl Cocoyl Taurate
Xanthan Gum
Cellulose Gum
Sodium Lauroyl Sarcosinate
Sucralose
Tetrapotassium Pyrophosphate
Sodium Phosphate
Lauryl Glucoside
Sodium Gluconate
1,2-Hexanediol
Mica
Zinc Lactate
Methyl Diisopropyl Propionamide
Titanium Dioxide
Iron Oxides
FD&C Red No.40
Package Label.Principal Display Panel
Hismile Lucky Charms Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste Gel
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