THE SIMPSONS PURPLE SQUISHEE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel

The Simpsons Purple Squishee Flavor Sodium Fluoride Anticavity Toothpast by

Drug Labeling and Warnings

The Simpsons Purple Squishee 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

Keep out of reach of children under 6 years old 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 methyl cocoyl taurate

Flavor

Sucralose

Xanthan Gum

Sodium Lauroyl Sarcosinate

Tetrapotassium Phosphate

1,2-Hexanediol

Cellulose Gum

Sodium Phosphate

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

D&C Red No. 33

FD&C Blue No. 1

Questions or comments

+1-302-440-3558

You may also report serious side effects to this phone number.

Label

INGREDIENTS AND APPEARANCE

THE SIMPSONS PURPLE SQUISHEE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-346
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)
SODIUM GLUCONATE (UNII: R6Q3791S76)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CELLULOSE GUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SUCRALOSE (UNII: 96K6UQ3ZD4)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
XANTHAN GUM (UNII: TTV12P4NEE)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM PHOSPHATE (UNII: SE337SVY37)
ZINC LACTATE (UNII: 2GXR25858Y)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-346-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/03/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/03/2025

Labeler - HISMILE PTY LTD (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
ACCUPAC LLC		061595175	pack(83013-346) , analysis(83013-346) , manufacture(83013-346) , label(83013-346)