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

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 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.

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 40

Blue 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 (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

[{"name": "BLUE 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM GLUCONATE", "unii": "R6Q3791S76", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAPRYLYL GLYCOL", "unii": "00YIU5438U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYL DIISOPROPYL PROPIONAMIDE", "unii": "6QOP5A9489", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ZINC LACTATE", "unii": "2GXR25858Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TETRAPOTASSIUM PYROPHOSPHATE", "unii": "B9W4019H5G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RED 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAUROYL SARCOSINATE", "unii": "632GS99618", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAURYL GLUCOSIDE", "unii": "76LN7P7UCU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,2-HEXANEDIOL", "unii": "TR046Y3K1G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.243", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC", "unii": "3980JIH2SW", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:51.794123 · Updated: 2026-03-14T23:13:18.140905