Active Ingredient
Sodium fluoride 0.24%
(0.14% w/v fluoride ion)
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast Gel
FDA Label NDC 83013-331
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 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast (NDC 83013-331). 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, keep out of reach of children under 6 years, when using this product, 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
Keep Out Of Reach Of Children Under 6 Years
Keep out of reach of children under 6 years. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison COntrol Center right away.
When Using This Product
Do not swallow
Do not use in eye area
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 Ingredients
Water
Sorbitol
Glycerin
Hydrated Silica
Xylitol
Sodium Phosphate
Xanthan Gum
Cellulose Gum
Sodium Lauroyl Sarcosinate
Tetrapotassium Pyrophosphate
1,2-Hexanediol
Sucralose
Lauryl Glucoside
Sodium Fluoride
Methyl Diisopropyl Propionamide
Sodium Gluconate
Zinc Lactate
FD&C Red No.40
FD&C Blue No.1
Label
Label (Label 331)
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Label (Label 331(2))
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