HISMILE- sodium fluoride gel

HISMILE by

Drug Labeling and Warnings

HISMILE by is a Otc medication manufactured, distributed, or labeled by Accupac LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Pink Lemonade 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 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

D&C Red No. 33

SPL UNCLASSIFIED SECTION

label

INGREDIENTS AND APPEARANCE

HISMILE 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 44038-0324
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
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XANTHAN GUM (UNII: TTV12P4NEE)
GLYCERIN (UNII: PDC6A3C0OX)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
XYLITOL (UNII: VCQ006KQ1E)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SUCRALOSE (UNII: 96K6UQ3ZD4)
ZINC LACTATE (UNII: 2GXR25858Y)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM PHOSPHATE (UNII: SE337SVY37)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44038-0324-1	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

Labeler - Accupac LLC (071609663)

Registrant - Accupac LLC (061595175)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(44038-0324)