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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Wonka 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

When using this product

Do not swallow

Do not use in eye area

Keep out of the reach of children under 6 years of age

If more than used for brushing is accidentally swallowed, get medical help of contact Poison Control Center right away.

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal of at least twice a day, or use as directed by a dentist of 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, Glycerin, Hydrated Silica, Xylitol, Sodium Phosphate, Xanthan Gum, Sodium Lauroyl Sarcosinate, Tetrapotassium Pyrophosphate, 1,2-Hexanediol, Cellulose Gum, Sucralose, Lauryl Glucoside, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Iron Oxides

label

HISMILE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-325
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
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
FERROUS OXIDE (UNII: G7036X8B5H)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM GLUCONATE (UNII: R6Q3791S76)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE (UNII: SE337SVY37)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
ZINC LACTATE (UNII: 2GXR25858Y)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHOCOLATE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-325-01	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	07/23/2024	11/22/2024

Labeler - HISMILE PTY LTD (758083252)

Registrant - Accupac LLC (061595175)

Revised: 11/2024

Document Id: 2784ba3d-d3e7-1059-e063-6394a90a2ff1

34390-5

Set id: 1deefb12-616b-a1c2-e063-6294a90aed4d

Version: 2

Effective Time: 20241122