Active Ingredient
Sodium Fluoride 0.24% (0.14% w/v fluoride ion)
Hismile Gel
FDA Label NDC 83013-318
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 83013-318). 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, warinings, 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
Warinings
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
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 ange 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, Hydrated Silica, Xylitol, Glycerin, Disodium Phosphate, Flavor, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Caprylyl Glycol, Pentylene Glycol, Benzyl Alcohol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, D&C Red No. 33
Other Information
Strawberry Flavor Sodium Fluoride Anticavity Toothpaste
Manufactured for:
Hismile Pty Ltd, 225 Burleigh
Connection Rd, Burleigh Waters,
Queensland, Australia 4220.
Formulated in Australia.
Made in USA.
www.hismileteeth.com
© Hismile Pty Ltd, 2022
TRUSTED BY DENTISTS
sugar-free
cruelty- free
no SLS & PEGs
vegan
Hismile uses the highest quality ingredients to provide a superior clean with oral health benefits. Paired with a refreshing burst of flavor, this toothpaste creates a unique smile care experience.
Label
Label (83013 318)
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