HISMILE- sodium fluoride 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 0.243%

(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 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-Hexanediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1.

label

INGREDIENTS AND APPEARANCE

HISMILE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-326
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
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM PHOSPHATE (UNII: SE337SVY37)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM GLUCONATE (UNII: R6Q3791S76)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-326-06	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

Labeler - HISMILE PTY LTD (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(83013-326)