CLASSIC MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel

Classic Mint Flavor Sodium Fluoride Anticavity Toothpast by

Drug Labeling and Warnings

Classic Mint Flavor Sodium Fluoride Anticavity Toothpast by is a Otc medication manufactured, distributed, or labeled by HISMILE PTY LTD, Nutrix International, 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

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

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Cellulose Gum

Flavor

Sodium Methyl Cocoyl Taurate

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Sucralose

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Label

INGREDIENTS AND APPEARANCE

CLASSIC MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-340
Route of Administration	TOPICAL

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 METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SUCRALOSE (UNII: 96K6UQ3ZD4)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM GLUCONATE (UNII: R6Q3791S76)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
ZINC LACTATE (UNII: 2GXR25858Y)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
XYLITOL (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-340-10	100 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/30/2025

Labeler - HISMILE PTY LTD (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
Nutrix International, LLC.		117341868	manufacture(83013-340)