hismile RED VELVET FLAVOR anticavity

hismile RED VELVET FLAVOR anticavity by

Drug Labeling and Warnings

hismile RED VELVET FLAVOR anticavity by is a Otc medication manufactured, distributed, or labeled by HISMILE PTY LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HISMILE RED VELVET FLAVOR ANTICAVITY- sodium fluoride paste, dentifrice 
HISMILE PTY LTD

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hismile RED VELVET FLAVOR anticavity

Drug Facts

Active ingredient

Sodium Fluoride 0.24%
(0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

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 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.

Other information

store in a cool, dry place.

Inactive ingredients

Water, Sorbitol, Hydrated Silica, Xylitol, Glycerin, Flavor, Disodium Phosphate, Sodium Lauroyl Sarcosinate, Xanthan Gum, Cellulose Gum, Tetrapotassium Pyrophosphate, Benzyl Alcohol, Pentylene Glycol, Caprylyl Glycol, Sucralose, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Benzoic Acid, Calcium Glycerophosphate, D&C Red No.33.

Questions or comments?

+1-302-440-3558
You may also report serious side effects to this phone number.

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.

Packaging

HISMILE RED VELVET FLAVOR ANTICAVITY 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-306
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ZINC LACTATE (UNII: 2GXR25858Y)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHOCOLATE (RED VELVET)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-306-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/13/2023	06/22/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/13/2023	06/22/2025

Labeler - HISMILE PTY LTD (758083252)

Revised: 5/2025

Document Id: 361e0069-2cda-2800-e063-6394a90a815e

34390-5

Set id: a2664194-7f59-4e6f-81b2-4fee74a1f876

Version: 3

Effective Time: 20250527