Active ingredient

Sodium Fluoride 0.243%

(0.14% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Sucralose

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Red 40

Blue 1

Label

label

GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83013-338
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.243 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BLUE 1 (UNII: H3R47K3TBD)
SODIUM GLUCONATE (UNII: R6Q3791S76)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
ZINC LACTATE (UNII: 2GXR25858Y)
TETRAPOTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
RED 40 (UNII: WZB9127XOA)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
SUCRALOSE (UNII: 96K6UQ3ZD4)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SORBITOL (UNII: 506T60A25R)
XYLITOL (UNII: VCQ006KQ1E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:83013-338-10	100 g in 1 TUBE; Type 0: Not a Combination Product	10/30/2025

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

Labeler - HISMILE PTY LTD (758083252)

Name	Address	ID/FEI	Business Operations
Establishment
Nutrix International, LLC.		117341868	manufacture(83013-338)

Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpaste