FDA.reportPublic FDA data

BRUSH BUDDIES CRAYOLA Mouthwash

Manufacturer
Kingkey MBC Life Technology Group co., LTD.
Effective date
2025-12-11
Label type
HUMAN OTC DRUG LABEL
Version
22
Source
full-release
Hydrated at
2026-06-01 01:22:28

Label at a glance#

ProductBRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON
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

（0.02% w/v fluoride ion)----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.lf 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 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）

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2682817sodium fluoride 0.03 % (fluoride ion 0.02 % ) MouthwashPSN22
2682817sodium fluoride 0.3 MG/ML MouthwashSCD22
2682817sodium fluoride 0.03 % (fluoride ion 0.02 % ) Oral RinseSY22

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130810147881192GTIN-13: 0810147881192
EAN-13: 0810147881192
GTIN-12: 810147881192
UPC-A: 810147881192
GTIN storage (14 digits): 00810147881192		1ad47834-4f8a-c692-e063-6294a90a7e77.jpg, watermelon_compressed.jpg

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
73928-016-01BRUSH BUDDIES CRAYOLA ANTICAVITY FLUORIDE WATERMELON355 mL in 1 BOTTLELIQUID35522

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
73928-01673928-016-01

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
SORBITOL506T60A25RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SUCRALOSE96K6UQ3ZD4IACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
GLYCERINPDC6A3C0OXIACT
XYLITOLVCQ006KQ1EIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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 WATERMELONSODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.188cddb2-c799-0897-e063-6294a90a5d962025-12-11WarningsExact identifier
ndc (package): 73928-016-01
ndc (product): 73928-016
ndc11 (package): 73928001601
spl id: 45af7f55-45e7-75f4-e063-6394a90adace
spl set id: 188cddb2-c799-0897-e063-6294a90a5d96

Reported adverse events (FAERS/openFDA)#

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