Otc - Active Ingredient
Active ingredient
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Hismile Gel, Dentifrice
FDA Label NDC 83013-335
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hismile Pty Ltd for the product Hismile (NDC 83013-335). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Labelfront (Labelfront)
Labelback (Labelback)
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