FDA.reportPublic FDA data

CLEAN BREATH TOOTH

Manufacturer
K.Boeun Pharmaceutical Co.,Ltd.
Effective date
2021-11-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:14

Label at a glance#

ProductCLEAN BREATH TOOTH
Active ingredientCALCIUM PHOSPHATE, DIBASIC, ANHYDROUS, CALCIUM CARBONATE, ALCLOXA, AMINOCAPROIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate

INACTIVE INGREDIENT SECTION

Water, D-Sorbitol Solution, Concentrated Glycerin, Silicon Dioxide, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Xanthangum, Mentha Oil, Enzymatically Modified Stevia, Titanium Oxide, Sodium Chloride, Propolis Extract, l-Menthol, Xylitol, Ascorbic Acid, Green Tea Extract, Aloe Extract, Tocopherol Acetate

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

WARNINGS SECTION

Warnings

Keep out of reach of children

■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
AMINOCAPROIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427

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
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
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
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
74724-0028-12025-01-30C16284748780-12cef2736-9511-d83d-e063-dadaa90ab31fd1feebb0-c685-25e0-e053-2995a90ac5ea

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
74724-0028-1CLEAN BREATH TOOTH180 g in 1 TUBEPASTE, DENTIFRICE1801

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74724-0028CLEAN BREATH TOOTH (PRECIPITATED CALCIUM CARBONATE, DIBASIC CALCIUM PHOSPHATE, AMINOCAPROIC ACID, ALUMINIUM CHLOROHYDROXY ALLANTOINATE) PASTE, DENTIFRICE [K.BOEUN PHARMACEUTICAL CO.,LTD.]1Legacy NDC, 1 package rows20211201_d1feebb0-c685-25e0-e053-2995a90ac5ea.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
74724-002874724-0028-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSL11K75P92JACTIB
CALCIUM CARBONATEH0G9379FGKACTIB
ALCLOXA18B8O9DQA2ACTIB
AMINOCAPROIC ACIDU6F3787206ACTIB

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
d1feeb95-7f4c-c8de-e053-2995a90aea5ed1feebb0-c685-25e0-e053-2995a90ac5ea2021-11-30WarningsExact identifier
spl id: d1feeb95-7f4c-c8de-e053-2995a90aea5e
spl set id: d1feebb0-c685-25e0-e053-2995a90ac5ea

Reported adverse events (FAERS/openFDA)#

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