grape bubblegum flavor sodium fluoride anticavity toothpaste

SPL v1

SPL

SPL Set ID 425b1a2e-7576-13a7-e063-6394a90aa865

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

blue 1 sodium gluconate water caprylyl glycol methyl diisopropyl propionamide hydrated silica zinc lactate tetrapotassium pyrophosphate red 40 sodium lauroyl sarcosinate sucralose lauryl glucoside sorbitol xylitol 1,2-hexanediol glycerin sodium phosphate, monobasic carboxymethylcellulose sodium, unspecified form

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2025-10-30

Purpose

Anticavity

Description

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

Medication Information

Warnings

Warnings

Purpose

Anticavity

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.

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 40

Blue 1

Description

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

Use

Aids in the prevention of dental cavities.

Label

Active Ingredient

Sodium Fluoride 0.243%

(0.14% w/v fluoride ion)

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

Warnings

Warnings

Purpose

Anticavity

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.

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 40

Blue 1

Use

Aids in the prevention of dental cavities.

Label

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(0.14% w/v fluoride ion)

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 40 Blue 1", "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: 2026-02-15T12:08:51.794123 · Updated: 2026-03-14T23:13:18.140905