HISMILE- magically delicious flavor sodium fluoride anticavity toothpaste gel, dentifrice

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

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Use

Aids in the prevention of dental cavities

WARNINGS

Warnings

When using this product

• Do not swallow
• Do not use in eye area

KEEP OUT OF REACH OF CHILDREN

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

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.

INACTIVE INGREDIENT

Water

Sorbitol

Glycerin

Hydrated Silica

Xylitol

Flavor

Sodium Methyl Cocoyl Taurate

Xanthan Gum

Cellulose Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

Sodium Phosphate

Lauryl Glucoside

Sodium Gluconate

1,2-Hexanediol

Mica

Zinc Lactate

Methyl Diisopropyl Propionamide

Titanium Dioxide

Iron Oxides

FD&C Red No.40

PRINCIPAL DISPLAY PANEL

Hismile Lucky Charms Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste Gel

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HISMILE 
magically delicious flavor sodium fluoride anticavity toothpaste gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-335
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
IRON OXIDES (UNII: 1K09F3G675)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SODIUM PHOSPHATE (UNII: SE337SVY37)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
MICA (UNII: V8A1AW0880)
CELLULOSE GUM (UNII: K679OBS311)

Product Characteristics
Color		Score
Shape		Size
Flavor	MARSHMALLOW	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-335-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/01/2025

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

Labeler - Hismile Pty Ltd (758083252)

Registrant - Hismile Pty Ltd (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(83013-335)