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SPL v2

SPL

SPL Set ID 22794069-382d-b71d-e063-6394a90aef6d

Route

DENTAL

Published

Effective Date 2024-07-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

1,2-hexanediol Sodium Gluconate Xylitol Glycerin Water Zinc Lactate Potassium Pyrophosphate Hydrated Silica Sodium Lauroyl Sarcosinate Lauryl Glucoside Sucralose Carboxymethylcellulose Sodium, Unspecified Form Xanthan Gum Methyl Diisopropyl Propionamide Sodium Phosphate Sorbitol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-15

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

Section 51945-4

Direction

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 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-Hexadediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

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

Section 51945-4 (51945-4)

Purpose

Anticavity

Direction

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 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-Hexadediol

Cellulose Gum

Sucralose

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

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", "Direction": "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 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-Hexadediol Cellulose Gum Sucralose Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate", "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: 2026-02-15T12:03:35.764427 · Updated: 2026-03-14T23:03:46.018464