FDA.reportPublic FDA data

Finefra Black Tooth

Manufacturer
Jewoo Medical Co,.Ltd | Korea Life Science Co.,ltd
Effective date
2019-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:02:19

Label at a glance#

ProductFinefra Black Tooth
Active ingredientSILICON DIOXIDE, ALCLOXA
Label structure8 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 INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Silica 15.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Mentha Piperita (Peppermint) Oil, Sophora Angustifolia Root Extract, Charcoal Powder, Xylitol, Menthol, Stevioside, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Carvone, Anethole, Hydroxyapatite, Glycyrrhiza Glabra (Licorice) Root Extract, Aloe Barbadensis Leaf Extract, Gentiana Lutea Root Extract, Lavandula Angustifolia (Lavender) Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chitosan, Chamomilla Recutita (Matricaria) Flower Extract, Propolis Extract, Scutellaria Baicalensis Root Extract, Silver, Mika, Commiphora Myrrha Oil, Krameria Triandra Root Extract

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

Warnings:

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.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809328356576GTIN-13: 8809328356576
EAN-13: 8809328356576
GTIN storage (14 digits): 08809328356576		finefra carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69653-110-022022-07-29C16284748780-1e4f33bdf-ad53-d8a0-e053-dadaa90a6e4e117060c4-5298-4027-bfb9-7db1a347a8d7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69653-110-01Finefra Black Tooth135 g in 1 TUBEPASTE, DENTIFRICE1351
69653-110-02Finefra Black Tooth1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69653-110FINEFRA BLACK TOOTH (SILICON DIOXIDE, ALCLOXA) PASTE, DENTIFRICE [JEWOO MEDICAL CO,.LTD]1Legacy NDC, 2 package rows20191226_117060c4-5298-4027-bfb9-7db1a347a8d7.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69653-11069653-110-01, 69653-110-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCLOXA18B8O9DQA2ACTIB
SORBITOL506T60A25RIACT
Water059QF0KO0RIACT

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
555dae8c-0e23-4b4a-9ce4-2c5417619a64117060c4-5298-4027-bfb9-7db1a347a8d72019-12-26WarningsExact identifier
spl id: 555dae8c-0e23-4b4a-9ce4-2c5417619a64
spl set id: 117060c4-5298-4027-bfb9-7db1a347a8d7

Reported adverse events (FAERS/openFDA)#

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