ICE POP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST- sodium fluoride gel

Ice Pop Flavor Sodium Fluoride Anticavity Toothpast by

Drug Labeling and Warnings

Ice Pop 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

Use

Aids in the prevention of dental cavities

Warnings

Warnings

When using this product

When using this product Do not swallow

Do not use

Do not use in eye area

Keep out of reach of children

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally seallowed, 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 seallowing).
• 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

Flavor

Sodium Phosphate

Xanthan Gum

Sodium Lauroyl Sarcosinate

Sucralose

Tetrapotassium Pyrophosphate

1,2-Hexanediol

Cellulose Gum

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1

label

INGREDIENTS AND APPEARANCE

ICE POP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPAST 
sodium fluoride gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83013-328
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
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM PHOSPHATE (UNII: SE337SVY37)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
GLYCERIN (UNII: PDC6A3C0OX)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)
XANTHAN GUM (UNII: TTV12P4NEE)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
ZINC LACTATE (UNII: 2GXR25858Y)
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)
SODIUM GLUCONATE (UNII: R6Q3791S76)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83013-328-06	60 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	08/30/2024

Labeler - HISMILE PTY LTD (758083252)

Establishment
Name	Address	ID/FEI	Business Operations
ACCUPAC LLC		061595175	manufacture(83013-328) , label(83013-328) , pack(83013-328)