FDA.reportPublic FDA data

FLAVON WHITE MINT TOOTH

Manufacturer
BS and Co. Ltd | BIOSTECH CO., LTD.
Effective date
2020-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:22:38

Label at a glance#

ProductFLAVON WHITE MINT TOOTH
Active ingredientCalcium Carbonate, Allantoin
Label structure10 sections

Indications and uses

Aids in the removal of plaque and prevention gingivitis and periodontitis.

Dosage and administration

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Calcium Carbonate 45.0%
Allantoin 1.0%

PURPOSE

OTC - PURPOSE SECTION

Anti-plaque
Anti-gingivitis, Anti-Periodontitis

Uses

INDICATIONS & USAGE SECTION

Aids in the removal of plaque and prevention gingivitis and periodontitis.

WARNINGS

WARNINGS SECTION

Keep out of the reach of children under 6 years of age.
If you accidentally swallow more than used for brushing, seek professional help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician. Do not swallow.
Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.
Children under 2 yrs.: Ask a dentist or physician.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Sorbitol, Sodium Bicarbonate, Sodium Lauryl Sulfate, Xylitol, Xanthan Gum, Mint Flavor, Menthol, Mentha Piperita Oil, Stevioside, Ascorbic Acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codem.site.naver.com/0nd8zwhite carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73660-003-022022-07-29C16284748780-1e4f33bdf-a4f1-d8a0-e053-dadaa90a6e4ec57f91dd-19f2-404e-a4d7-dd47a0c505fd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73660-003-01FLAVON WHITE MINT TOOTH50 g in 1 BOTTLEPOWDER, DENTIFRICE501
73660-003-02FLAVON WHITE MINT TOOTH1 in 1 CARTONPOWDER, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73660-003FLAVON WHITE MINT TOOTH (CALCIUM CARBONATE, ALLANTOIN) POWDER, DENTIFRICE [BS AND CO. LTD]1Legacy NDC, 2 package rows20200725_c57f91dd-19f2-404e-a4d7-dd47a0c505fd.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73660-00373660-003-01, 73660-003-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Calcium CarbonateH0G9379FGKACTIM
Allantoin344S277G0ZACTIB
Sorbitol506T60A25RIACT
Sodium Bicarbonate8MDF5V39QOIACT
Sodium Lauryl Sulfate368GB5141JIACT
XylitolVCQ006KQ1EIACT
Xanthan GumTTV12P4NEEIACT
MentholL7T10EIP3AIACT
PEPPERMINT OILAV092KU4JHIACT
Stevioside0YON5MXJ9PIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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
c61ece91-4e52-4254-9f15-d46aaa7fa071c57f91dd-19f2-404e-a4d7-dd47a0c505fd2020-07-25WarningsExact identifier
spl id: c61ece91-4e52-4254-9f15-d46aaa7fa071
spl set id: c57f91dd-19f2-404e-a4d7-dd47a0c505fd

Reported adverse events (FAERS/openFDA)#

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