FDA.reportPublic FDA data

Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR

Manufacturer
Ashtel Studios Inc.
Effective date
2024-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:34

Label at a glance#

ProductBrush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

helps protect teeth against cavities.

Dosage and administration

Adults and children 6 years and  older: • Use daily after you brush your teeth with toothpaste. • Rinse toothpaste from mouth prior to use. • Shake well before each use. •  Twist and remove cap. • Rinse or gargle for 30 seconds with 15 ml and spit out. •  Do not swallow the rinse. •  Do not eat or drink for 30 minutes after rinsing. • Supervise children as necessary. • Children under 6 years of age, consult with a...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02%
(0.02% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect teeth against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years and older:
• Use daily after you brush your teeth with toothpaste.
• Rinse toothpaste from mouth prior to use.
• Shake well before each use.
•  Twist and remove cap.
• Rinse or gargle for 30 seconds with 15 ml and spit out.
• Do not swallow the rinse.
• Do not eat or drink for 30 minutes after rinsing.
• Supervise children as necessary.
• Children under 6 years of age, consult with a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Glycerin, Xylitol, Sodium Benzoate, Potassium Sorbate, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Saccharin, Cetylpyridinium Chloride, Methyl Diisopropyl Propionamide, Sucralose, Citric Acid, D&C Red No.33 (CI 17200)

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

Silly scents

ALCOHOL & SUGAR FREE
PARABEN FREE

HELPS PREVENT CAVITIES
make brushing fun!®

OFFICIAL LICENSED PRODUCT
DESIGNED IN U.S.A. MANUFACTURED IN CHINA

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
©2024 CRAYOLA, EASTON, PA 18044-0431.
Crayola™, Silly Scents™ and Chevron Design™ are trademarks of Crayola used under license.

BRUSH BUDDIES®
BRUSHBUDDIES.COM
COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
DISTRIBUTED BY:
ASHTEL STUDIOS, INC.
ONTARIO, CA 91761, USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Anticavity Fluoride MouthwashAnticavity Fluoride Mouthwash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-089-01Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR355 mL in 1 BOTTLE, PLASTICMOUTHWASH3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-089BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE - BUBBLE GUM FLAVOR (SODIUM FLUORIDE) MOUTHWASH [ASHTEL STUDIOS INC.]1Current NDC, 1 package rows20240614_a37e9d9c-dca9-4d58-a716-4514ebe8ec88.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-08970108-089-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
D&C RED NO. 339DBA0SBB0LIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brush Buddies Crayola ANTICAVITY FLUORIDE - BUBBLE GUM FLAVORSODIUM FLUORIDEAshtel Studios Inc.a37e9d9c-dca9-4d58-a716-4514ebe8ec882024-06-11WarningsExact identifier
ndc (package): 70108-089-01
ndc (product): 70108-089
ndc11 (package): 70108008901
spl id: 61af8bd7-6c21-40e9-bc94-08557e53baea
spl set id: a37e9d9c-dca9-4d58-a716-4514ebe8ec88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.