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SPL v2

SPL

SPL Set ID 2279d5a8-8ee4-4e81-e063-6394a90afb9c

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

Xylitol Sodium Phosphate 1,2-hexanediol Carboxymethylcellulose Sodium, Unspecified Form Water Sucralose Zinc Lactate Methyl Diisopropyl Propionamide Sorbitol Sodium Gluconate Fd&c Blue No. 1 Xanthan Gum Glycerin Sodium Lauroyl Sarcosinate Hydrated Silica Lauryl Glucoside Potassium Pyrophosphate

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

Warnings

Warnings

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 habtis (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist of doctor.

Package Label

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-Hexadediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1.

When Using This Product

Do not swallow

Do not use in eye area

Keep Out of Reach of Children Under 6 Years of Age

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

Structured Label Content

Use

Aids in the prevention of dental cavities

Purpose

Anticavity

Warnings

Warnings

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 habtis (to minimize swallowing).

Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist of doctor.

Package Label (Package label)

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-Hexadediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

FD&C Blue No. 1.

When Using This Product (When using this product)

Do not swallow

Do not use in eye area

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

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "Aids in the prevention of dental cavities", "Purpose": "Anticavity", "Warnings": "Warnings", "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 habtis (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist of 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-Hexadediol Cellulose Gum Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate FD&C Blue No. 1.", "When using this product": "Do not swallow Do not use in eye area", "Keep out of reach of children under 6 years of age": "If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:35.766434 · Updated: 2026-03-14T23:03:46.018464