HISMILE- strawberry flavor sodium fluoride anticavity toothpaste gel

Hismile by

Drug Labeling and Warnings

Hismile by is a Otc medication manufactured, distributed, or labeled by Hismile Pty Ltd, Accupac, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

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

INGREDIENTS AND APPEARANCE

HISMILE 
strawberry flavor sodium fluoride anticavity toothpaste gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-318
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
SORBITOL (UNII: 506T60A25R)
ZINC LACTATE (UNII: 2GXR25858Y)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM GLUCONATE (UNII: R6Q3791S76)

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-318-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/15/2024

Labeler - Hismile Pty Ltd (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		061595175	manufacture(83013-318)