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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Cherry 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 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 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

1,2-Hexnediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

label

HISMILE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-321
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 PHOSPHATE (UNII: SE337SVY37)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ZINC LACTATE (UNII: 2GXR25858Y)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM GLUCONATE (UNII: R6Q3791S76)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-321-01	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 (071609663)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(83013-321)

Revised: 11/2024

Document Id: 2784b689-c9f3-b127-e063-6394a90ac537

34390-5

Set id: 1e7b7ac2-1945-1fb5-e063-6294a90a7387

Version: 2

Effective Time: 20241122