Brush Buddies®

SPL v1

SPL

SPL Set ID 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4

Route

DENTAL

Published

Effective Date 2025-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.243 g)

Inactive Ingredients

Sorbitol Silicon Dioxide Water Polyethylene Glycol 1600 Xylitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Benzyl Alcohol Sodium Benzoate Saccharin Sodium Sodium Phosphate, Tribasic, Anhydrous Fd&c Red No. 40

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-01-29

Description

Sodium Fluoride 0.243% (Fluoride ion content 1100 ppm)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.243% (Fluoride ion content 1100 ppm)

Uses

helps protect against cavities.

Section 42229-5

BrushBuddies^®

BUBBLe GUM FLAVOR

HeLPS PReVeNT CAViTieS

make brushing fun!^®

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS.

NOT TESTED ON ANIMALS.

MY LITTLE PONY and all related characters are trademarks of Hasbro and are used with permission.

©2025 Hasbro. All Rights Reserved. Licensed by Hasbro

DESIGNED IN U.S.A. • MADE IN INDIA

WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Section 50565-1

Keep out of reach of children under 6 years of age. If you accidently swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Packaging

Directions

Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
Do not swallow.
Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium Fluoride 0.243%

(Fluoride ion content 1100 ppm)

Inactive Ingredients

Sorbitol, Silica, Water, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Red 40

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

Uses

helps protect against cavities.

Section 42229-5 (42229-5)

BrushBuddies^®

BUBBLe GUM FLAVOR

HeLPS PReVeNT CAViTieS

make brushing fun!^®

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS.

NOT TESTED ON ANIMALS.

DESIGNED IN U.S.A. • MADE IN INDIA

WWW.BRUSHBUDDIES.COM

QUESTIONS OR COMMENTS?

1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.

ONTARIO, CALIFORNIA 91761

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If you accidently swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Purpose

Anticavity

Packaging

Directions

Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
Do not swallow.
Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient (Active ingredient)

Sodium Fluoride 0.243%

(Fluoride ion content 1100 ppm)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Silica, Water, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Red 40

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps protect against cavities.", "42229-5": "BrushBuddies ® BUBBLe GUM FLAVOR HeLPS PReVeNT CAViTieS make brushing fun! ® CAUTION: AVOID EXCESSIVE INGESTION. NOT FOR PETS. NOT TESTED ON ANIMALS. MY LITTLE PONY and all related characters are trademarks of Hasbro and are used with permission. ©2025 Hasbro. All Rights Reserved. Licensed by Hasbro DESIGNED IN U.S.A. • MADE IN INDIA WWW.BRUSHBUDDIES.COM QUESTIONS OR COMMENTS? 1-909-434-0911 INTERNATIONAL PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE DISTRIBUTED BY ASHTEL STUDIOS INC. ONTARIO, CALIFORNIA 91761", "50565-1": "Keep out of reach of children under 6 years of age. If you accidently swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.", "Purpose": "Anticavity", "Directions": "Adults and children 2 years and older : brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. Do not swallow. Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 2 years of age: Consult a dentist or doctor.", "Active ingredient": "Sodium Fluoride 0.243% (Fluoride ion content 1100 ppm)", "Inactive ingredients": "Sorbitol, Silica, Water, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Red 40", "Questions or comments?": "Call toll free 1-877-274-8358"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:28.457931 · Updated: 2026-03-14T23:07:22.014703