Strawberry Flavor Sodium Fluoride Anticavity Toothpaste

SPL v2

SPL

SPL Set ID 426c2aca-ca2b-5e34-e063-6294a90ae37c

Route

TOPICAL

Published

Effective Date 2025-10-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

Caprylyl Glycol Methyl Diisopropyl Propionamide 1,2-hexanediol Cellulose Gum Sodium Lauroyl Sarcosinate Red 33 Xylitol Sodium Phosphate Lauryl Glucoside Water Zinc Lactate Glycerin Hydrated Silica Sucralose Sorbitol Tetrapotassium Pyrophosphate Sodium Gluconate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-31

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 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.

Active Ingredient

Sodium Fluoride 0.243%

(0.14% w/v fluoride ion)

Inactive Ingredients

Water

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Cellulose Gum

Flavor

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Sucralose

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Red 33

When Using This Product

Do not swallow
Do not use in eye area

Keep Out of Reach of Children Under 6 Years

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.

Label

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 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

Glycerin

Hydrated Silica

Xylitol

Sorbitol

Cellulose Gum

Flavor

1,2-Hexanediol

Sodium Phosphate

Sodium Lauroyl Sarcosinate

Tetrapotassium Pyrophosphate

Sucralose

Caprylyl Glycol

Lauryl Glucoside

Methyl Diisopropyl Propionamide

Sodium Gluconate

Zinc Lactate

Red 33

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 (Keep out of reach of children under 6 years)

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 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 Glycerin Hydrated Silica Xylitol Sorbitol Cellulose Gum Flavor 1,2-Hexanediol Sodium Phosphate Sodium Lauroyl Sarcosinate Tetrapotassium Pyrophosphate Sucralose Caprylyl Glycol Lauryl Glucoside Methyl Diisopropyl Propionamide Sodium Gluconate Zinc Lactate Red 33", "When using this product": "Do not swallow Do not use in eye area", "Keep out of reach of children under 6 years": "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: 2026-02-15T12:08:54.849838 · Updated: 2026-03-14T23:13:23.763125