SPL v2
SPL
SPL Set ID 2279fd5c-fc79-bda7-e063-6394a90a23f8
Route
DENTAL
Published
Effective Date 2024-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.243 g)
Inactive Ingredients
Sodium Lauroyl Sarcosinate 1,2-hexanediol Ferrous Oxide Hydrated Silica Lauryl Glucoside Sucralose Sodium Gluconate Methyl Diisopropyl Propionamide Sodium Phosphate Potassium Pyrophosphate Zinc Lactate Xanthan Gum Xylitol Glycerin Carboxymethylcellulose Sodium, Unspecified Form Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-23

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Purpose

Anticavity


Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (0.14 w/v fluoride ion)

Use

Aids in the prevention of dental cavities

Label

Warnings

Warnings

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal of at least twice a day, or use as directed by a dentist of 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.

Active Ingredient

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Inactive Ingredients

Water, Sorbitol, Glycerin, Hydrated Silica, Xylitol, Sodium Phosphate, Xanthan Gum, Sodium Lauroyl Sarcosinate, Tetrapotassium Pyrophosphate, 1,2-Hexanediol, Cellulose Gum, Sucralose, Lauryl Glucoside, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Iron Oxides

When Using This Product

Do not swallow

Do not use in eye area

Keep Out of the Reach of Children Under 6 Years of Age

If more than used for brushing is accidentally swallowed, get medical help of contact Poison Control Center right away.


Structured Label Content

Use

Aids in the prevention of dental cavities

Label (label)

Purpose

Anticavity

Warnings

Warnings

Directions

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal of at least twice a day, or use as directed by a dentist of 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.

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(0.14 w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Water, Sorbitol, Glycerin, Hydrated Silica, Xylitol, Sodium Phosphate, Xanthan Gum, Sodium Lauroyl Sarcosinate, Tetrapotassium Pyrophosphate, 1,2-Hexanediol, Cellulose Gum, Sucralose, Lauryl Glucoside, Methyl Diisopropyl Propionamide, Sodium Gluconate, Zinc Lactate, Iron Oxides

When Using This Product (When using this product)

Do not swallow

Do not use in eye area

Keep Out of the Reach of Children Under 6 Years of Age (Keep out of the reach of children under 6 years of age)

If more than used for brushing is accidentally swallowed, get medical help of contact Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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