28TAK GUM CARE TOOTH

Manufacturer
ELMEDITEC CO.,LTD
Effective date
2018-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:19

Label at a glance#

Product28TAK GUM CARE TOOTH
Active ingredientCALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, ALCLOXA, AMINOCAPROIC ACID
Label structure8 sections

Indications and uses

Uses: Keep your teeth white and strong. Keep your mouth clean. Refresh the inside of the mouth. To prevent tooth decay and remove bad breath. Increase esthetic effect. Removal of plaque (anti-plaque)

Dosage and administration

Directions: Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) Children under 2 years: Ask a dentist or physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: CALCIUM CARBONATE 30.0%, ANHYDROUS DIBASIC CALCIUM PHOSPHATE 0.1%, ALCLOXA 0.1%, AMINOCAPROIC ACID 0.1%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

D-Sorbitol Solution, Aqua, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xantangum, L-Menthol, Peppermint Oil, Mint Flavor, Propolis Powder, Xylitol, Green Tea Extract, Eucalyptus Extract, Chamomile Extract, Sage Extract, Aloe Extract, Taraxacum officinale Extract, Olive leaf extract, Mastic Oil

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

Warnings:

(1) Do not swallow and rinse mouth thoroughly after use (2) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (3) For children under 6 years of age, use small amounts of toothpaste. And use it under the supervision of a guardian to avoid sucking or swallowing. (4) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (5) Keep out of the reach of children under 6 years of age.

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.

Uses

INDICATIONS & USAGE SECTION

Uses:

Keep your teeth white and strong. Keep your mouth clean. Refresh the inside of the mouth. To prevent tooth decay and remove bad breath. Increase esthetic effect. Removal of plaque (anti-plaque)

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years: Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

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
72440-030-022020-01-31C16284748780-19d75b9d0-8f5f-f424-e053-dadaa90a57cedcb4813b-abe1-408f-8fe0-0ba1887071e1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72440-030-0128TAK GUM CARE TOOTH120 g in 1 TUBEPASTE, DENTIFRICE1201
72440-030-0228TAK GUM CARE TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72440-03028TAK GUM CARE TOOTH (CALCIUM CARBONATE, ANHYDROUS DIBASIC CALCIUM PHOSPHATE, ALCLOXA, AMINOCAPROIC ACID) PASTE, DENTIFRICE [ELMEDITEC CO.,LTD]1Legacy NDC, 2 package rows20180717_dcb4813b-abe1-408f-8fe0-0ba1887071e1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72440-03072440-030-01, 72440-030-02

Ingredients#

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

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

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
b170f130-1baa-4c37-8706-c901719c9ee3dcb4813b-abe1-408f-8fe0-0ba1887071e12018-07-17WarningsExact identifier
spl id: b170f130-1baa-4c37-8706-c901719c9ee3
spl set id: dcb4813b-abe1-408f-8fe0-0ba1887071e1

Reported adverse events (FAERS/openFDA)#

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