HISMILE MIFFY SWEET APPLE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel

Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast by

Drug Labeling and Warnings

Hismile Miffy Sweet Apple Flavor Sodium Fluoride Anticavity Toothpast 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 0.24%

(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 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

Cellulose Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

label

INGREDIENTS AND APPEARANCE

HISMILE MIFFY SWEET APPLE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-333
Route of Administration	ORAL

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)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM GLUCONATE (UNII: R6Q3791S76)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
ZINC LACTATE (UNII: 2GXR25858Y)
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
XANTHAN GUM (UNII: TTV12P4NEE)
CELLULOSE GUM (UNII: K679OBS311)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE (Green Apple FLASN 13453)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-333-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/14/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	01/14/2025

Labeler - Hismile Pty Ltd (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac LLC		061595175	manufacture(83013-333)