crayola anticavity fluoride toothpaste - bubble gum flavor

SPL v2

SPL

SPL Set ID ec66246f-06e2-4da1-b9d5-ce2a7815ffd1

Route

dental

Published

Effective Date 2023-09-14

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 2023-09-06

Purpose

Anticavity

Description

Sodium fluoride 0.243% (Fluoride ion content 1100 ppm)

Medication Information

Uses

helps protect teeth and roots against cavities.

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.

Inactive Ingredients

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

Description

Sodium fluoride 0.243% (Fluoride ion content 1100 ppm)

Section 42229-5

BrushBuddies^®

Silly Scents

HELPS PREVENT CAVITIES

BUBBLE GUM FLAVOR

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS.

NOT TESTED ON ANIMALS.

OFFICIAL LICENSED PRODUCT

DESIGNED IN U.S.A. • MADE IN INDIA

QUALITY GUARANTEE

Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST

ABOUT US

Crayola A Hallmark Company

©2023 CRAYOLA, EASTON, PA 18044-0431.

Crayola™, Silly Scents™ and Chevron Design™ are trademarks of Crayola used under license.

make brushing fun!^®

WWW.BRUSHBUDDIES.COM

• 1-909-434-0911 INTERNATIONAL

DISTRIBUTED BY ASHTEL STUDIOS INC., • ONTARIO, CALIFORNIA 91761

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Sodium fluoride 0.243%

(Fluoride ion content 1100 ppm)

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

Uses

helps protect teeth and roots against cavities.

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.

Inactive Ingredients (Inactive ingredients)

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

Section 42229-5 (42229-5)

BrushBuddies^®

Silly Scents

HELPS PREVENT CAVITIES

BUBBLE GUM FLAVOR

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS.

NOT TESTED ON ANIMALS.

OFFICIAL LICENSED PRODUCT

DESIGNED IN U.S.A. • MADE IN INDIA

QUALITY GUARANTEE

Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST

ABOUT US

Crayola A Hallmark Company

©2023 CRAYOLA, EASTON, PA 18044-0431.

Crayola™, Silly Scents™ and Chevron Design™ are trademarks of Crayola used under license.

make brushing fun!^®

WWW.BRUSHBUDDIES.COM

• 1-909-434-0911 INTERNATIONAL

DISTRIBUTED BY ASHTEL STUDIOS INC., • ONTARIO, CALIFORNIA 91761

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

Section 50565-1 (50565-1)

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

Packaging

Drug Facts

Active Ingredient (Active ingredient)

Sodium fluoride 0.243%

(Fluoride ion content 1100 ppm)

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.243", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 1600", "unii": "1212Z7S33A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS", "unii": "SX01TZO3QZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "helps protect teeth and roots against cavities.", "42229-5": "BrushBuddies ® Silly Scents HELPS PREVENT CAVITIES BUBBLE GUM FLAVOR CAUTION: AVOID EXCESSIVE INGESTION. NOT FOR PETS. NOT TESTED ON ANIMALS. OFFICIAL LICENSED PRODUCT DESIGNED IN U.S.A. • MADE IN INDIA QUALITY GUARANTEE Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST ABOUT US Crayola A Hallmark Company ©2023 CRAYOLA, EASTON, PA 18044-0431. Crayola™, Silly Scents™ and Chevron Design™ are trademarks of Crayola used under license. make brushing fun! ® WWW.BRUSHBUDDIES.COM • 1-909-434-0911 INTERNATIONAL DISTRIBUTED BY ASHTEL STUDIOS INC., • ONTARIO, CALIFORNIA 91761 PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE", "50565-1": "Keep out of reach of children under 6 years of age. If you accidentally 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, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, 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

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Source: dailymed · Ingested: 2026-02-15T12:05:46.845605 · Updated: 2026-03-14T23:08:04.646392