FDA.reportPublic FDA data

BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY

Manufacturer
Kingkey MBC Life Technology Group co., LTD.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:38:50

Label at a glance#

ProductBRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY
Active ingredientSODIUM FLUORIDE
Label structure8 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 dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.03%

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect teeth against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age. lf 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 Notswallow the rinse.
  • Do Noteat 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, POTASSIUM SORBATE, SODIUM BENZOATE, PEG-40 HYDROGENATED CASTOR OIL, FLAVOR
SODIUM FLUORIDE, SODIUM SACCHARIN, CETYLPYRIDINIUM CHLORIDE, SUCRALOSE, CITRIC ACID, METHYL DIISOPROPYL PROPIONAMIDE
D&C Red No.33（CI 17200, FD&C RED NO. 40

Questions or comments?

SPL UNCLASSIFIED SECTION

Call toll free 1-877-274-8358

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2682817sodium fluoride 0.03 % (fluoride ion 0.02 % ) MouthwashPSN2
2682817sodium fluoride 0.3 MG/ML MouthwashSCD2
2682817sodium fluoride 0.03 % (fluoride ion 0.02 % ) Oral RinseSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73928-021-01BRUSH BUDDIES HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRY355 mL in 1 BOTTLELIQUID3552

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
73928-02173928-021-01

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
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SUCRALOSE96K6UQ3ZD4IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-05-22full-release2026-06-01 00:12:58

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 HOTWHEEL ANTICAVITY FLUORIDE STRAWBERRYSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.a3e989f8-e6a2-4e13-8faa-77e95895166d2025-10-09WarningsExact identifier
ndc (package): 73928-021-01
ndc (product): 73928-021
ndc11 (package): 73928002101
spl id: 40b9ee89-d0bf-547c-e063-6294a90ac0f5
spl set id: a3e989f8-e6a2-4e13-8faa-77e95895166d

Reported adverse events (FAERS/openFDA)#

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