Active Ingredient
Sodium Fluoride 0.243%
(0.14 w/v fluoride ion)
Hismile Gel
FDA Label NDC 83013-327
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 83013-327). 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 active ingredient, purpose, use, warnings, when using this product, keep out of reach of children under 6 years of age, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Anticavity
Use
Aids in the prevention of dental cavities
Warnings
Warnings
When Using This Product
- Do not swallow
- Do not use in eye area
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 habtis ( 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 Ingredients
Water
Sorbitol
Hydrated Silica
Glycerin
Xylitol
Disodium Phosphate
Sucralose
Sodium Lauroyl Sarcosinate
Xanthan Gum
Cellulose Gum
Flavor
Tetrapotassium Pyrophosphate
Caprylyl Glycol
Benzyl Alcohol
Menthol
Sodium Gluconate
Pentylene Glycol
Zinc Lactate
Benzoic Acid
Methyl Diisopropyl Propionamide
Titanium Dioxide
Label
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