FDA.reportPublic FDA data

Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR

Manufacturer
Ashtel Studios Inc.
Effective date
2024-07-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:16:31

Label at a glance#

ProductBrush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON 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 de...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.05%
(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, FD&C Yellow No.5 (CI 19140), FD&C Blue No.1 (CI 42090)

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

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN1
240698sodium fluoride 0.5 MG/ML MouthwashSCD1
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-093-01Brush Buddies Crayola ANTICAVITY FLUORIDE - WATERMELON FLAVOR355 mL in 1 BOTTLE, PLASTICMOUTHWASH3551

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-093BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE - WATERMELON FLAVOR (SODIUM FLUORIDE) MOUTHWASH [ASHTEL STUDIOS INC.]1Current NDC, 1 package rows20240805_32780fe9-82bf-42f8-8218-bed5bc579c72.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-09370108-093-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 - WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios Inc.32780fe9-82bf-42f8-8218-bed5bc579c722024-07-30WarningsExact identifier
ndc (package): 70108-093-01
ndc (product): 70108-093
ndc11 (package): 70108009301
spl id: 00503b11-5447-4c14-8446-fd2f0b4cbf7c
spl set id: 32780fe9-82bf-42f8-8218-bed5bc579c72

Reported adverse events (FAERS/openFDA)#

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