HISMILE- banana 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

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 neceaasry 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, Benzyl Alcohol, Sucralose, Menthol, Sodium Gluconate, Pentylene Glycol, Zinc Lactate, Methyl Diisopropyl Propionamide, Benzoic Acid

label

Banana 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 
banana flavor sodium fluoride anticavity toothpaste gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-319
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
SUCRALOSE (UNII: 96K6UQ3ZD4)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SORBITOL (UNII: 506T60A25R)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
BENZYL ALCOHOL (UNII: LKG8494WBH)
MENTHOL (UNII: L7T10EIP3A)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ZINC LACTATE (UNII: 2GXR25858Y)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Product Characteristics
Color		Score
Shape		Size
Flavor	BANANA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-319-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/14/2024

Labeler - Hismile Pty Ltd (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		061595175	manufacture(83013-319)