HISMILE by HISMILE PTY LTD / Accupac LLC

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]

HISMILE- sodium fluoride gel 
HISMILE PTY LTD

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Cotton Candy Flavor Sodium Fluoride Anticavity Toothpaste

Active ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Warnings

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.

When using this product

Do not swallow

Do not use in eye area

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably 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 habtis (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

Glycerin

Hydrated Silica

Xylitol

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No. 33

Label

Cotton Candy Label.jpg

HISMILE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-323
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
GLYCERIN (UNII: PDC6A3C0OX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PHOSPHATE (UNII: SE337SVY37)
XYLITOL (UNII: VCQ006KQ1E)
SORBITOL (UNII: 506T60A25R)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)

Product Characteristics
Color		Score
Shape		Size
Flavor	COTTON CANDY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-323-01	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/15/2024	11/22/2024

Labeler - HISMILE PTY LTD (758083252)

Registrant - Accupac LLC (061595175)

Revised: 11/2024

Document Id: 2784a0aa-44c6-9316-e063-6394a90a6555

34390-5

Set id: 1def31b5-d308-2962-e063-6294a90a444f

Version: 2

Effective Time: 20241122