hismile WATERMELON FLAVOR anticavity
hismile WATERMELON FLAVOR anticavity
8f5c7311-2111-4848-bdc3-9d8671b5a8d5
HUMAN OTC DRUG LABEL
May 27, 2025
HISMILE PTY LTD
DUNS: 758083252
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Packaging
INDICATIONS & USAGE SECTION
Use
aids in the prevention of dental cavities
SPL UNCLASSIFIED SECTION
Manufactured for:
Hismile Pty Ltd, 225 Burleigh
Connection Rd, Burleigh Waters,
Queensland, Australia 4220.
Formulated in Australia.
Made in Thailand.
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.
OTC - ACTIVE INGREDIENT SECTION
Active ingredient
Sodium Fluoride 0.24%
(0.14% w/v fluoride ion)
OTC - PURPOSE SECTION
Purpose
Anticavity
WARNINGS SECTION
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
DOSAGE & ADMINISTRATION SECTION
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.
STORAGE AND HANDLING SECTION
Other information
store in a cool, dry place.
INACTIVE INGREDIENT SECTION
Inactive ingredients
Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Calcium Glycerophosphate, Cellulose Gum, Xanthan Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Caprylyl Glycol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid.
OTC - QUESTIONS SECTION
Questions or comments?
+1-302-440-3558
You may also report serious side effects to this phone number.