FDA.reportPublic FDA data

BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM

Manufacturer
Kingkey MBC Life Technology Group co., LTD
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:22:29

Label at a glance#

ProductBRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM
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 dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE 0.02%

Puropse

OTC - PURPOSE SECTION

(0.02% w/v fluorid inn)---------Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect teeth against cavities.

Warnings

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.

WARNINGS SECTION

Keep out of reac of children under 6 years of age.lf youaccidentally swallow more than used for rinsing, seek professionahelp 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 ingrdients

INACTIVE INGREDIENT SECTION

WATER
SORBITOL
GLYCERIN
XYLITOL
POTASSIUM SORBATE
SODIUM BENZOATE
PEG-40 HYDROGENATED CASTOR OIL
FLAVOR
SODIUM SACCHARIN
CETYLPYRIDINIUM CHLORIDE

METHYL DIISOPROPYL PROPIONAMIDE

SUCRALOSE
CITRIC ACIDD&C Red No.33（CI 17200）

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN3
313029sodium fluoride 0.2 MG/ML MouthwashSCD3
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY3
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
73928-043-01BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE BUBBLEGUM355 mL in 1 BOTTLELIQUID3553

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
73928-04373928-043-01

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

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 BUBBLEGUMSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD1b74f072-c33b-c6e2-e063-6394a90ab1e62025-12-11WarningsExact identifier
ndc (package): 73928-043-01
ndc (product): 73928-043
ndc11 (package): 73928004301
spl id: 45af9913-4e6d-c494-e063-6294a90ab6cd
spl set id: 1b74f072-c33b-c6e2-e063-6394a90ab1e6

Reported adverse events (FAERS/openFDA)#

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