Finefra Aid Tooth

Manufacturer
Jewoo Medical Co,.Ltd | Woorilife&Health
Effective date
2020-06-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:15:59

Label at a glance#

ProductFinefra Aid Tooth
Active ingredientCALCIUM CARBONATE, .ALPHA.-TOCOPHEROL ACETATE, ALCLOXA, DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Label structure10 sections

Indications and uses

Uses: Aids in the prevention of cavities, plaque, and gingivitis.

Dosage and administration

Directions: 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 INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Precipitated Calcium Carbonate 0.10%
Tocopherol Acetate 0.04%
Aluminum Chlorohydroxy Allantoinate 0.04%
Dibasic Calcium Phosphate Hydrate 0.04%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D-Sorbitol Solution, Purified Water in Bulk, Glycerin, Silica, Sodium Cocoyl Glutamate, Mica, Peppermint Flavor, Active Carbon, Steviol Glycoside, Carboxymethylcellulose Sodium, Chitosan, Xylitol, Grapefruit Seed Extract, Anethole, L-Menthol, Propolis Extract, Scutellaria Root Extract, Sophora Extract, Aloe Extract(09), Gentian Extract, Lavender Extract(1), Rosemary Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Eucalyptus Oil, Glycyrrhiza Extract, Sage Extract, Argentum

PURPOSE

OTC - PURPOSE SECTION

Anticavity

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.

Uses

INDICATIONS & USAGE SECTION

Uses:

Aids in the prevention of cavities, plaque, and gingivitis.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

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.

Package Label: Finefra Aid Toothpaste 20g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of tubeImage of tube

Package Label: Finefra Aid Toothpaste 100g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Package Label: Finefra Aid Toothpaste 135g

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

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69653-130-01Finefra Aid Tooth20 g in 1 TUBEPASTE, DENTIFRICE201
69653-130-02Finefra Aid Tooth100 g in 1 CARTONPASTE, DENTIFRICE1001
69653-130-03Finefra Aid Tooth135 g in 1 CARTONPASTE, DENTIFRICE1351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69653-130FINEFRA AID TOOTH (PRECIPITATED CALCIUM CARBONATE, TOCOPHEROL ACETATE, ALUMINUM CHLOROHYDROXY ALLANTOINATE, DIBASIC CALCIUM PHOSPHATE HYDRATE) PASTE, DENTIFRICE [JEWOO MEDICAL CO,.LTD]1Legacy NDC, 3 package rows20200604_b82ec80b-87a6-4670-b139-775e6028b62f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69653-13069653-130-01, 69653-130-02, 69653-130-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
bc4e2efb-b5b4-4273-82ef-eac710260d39b82ec80b-87a6-4670-b139-775e6028b62f2020-06-03WarningsExact identifier
spl id: bc4e2efb-b5b4-4273-82ef-eac710260d39
spl set id: b82ec80b-87a6-4670-b139-775e6028b62f

Reported adverse events (FAERS/openFDA)#

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