FDA.reportPublic FDA data

Finefra Tooth

Manufacturer
Jewoo Medical Co,.Ltd | Finefrajapan Co.,ltd. | NEO-MEDICALFARM CO.,LTD
Effective date
2018-11-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:57:25

Label at a glance#

ProductFinefra 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, Mica, Sodium Cocoyl Glutamate, Mentha Piperita, (Peppermint) Oil, Cellulose Gum, Stevioside, Menthol, Xylitol, Glycyrrhiza, Uralensis (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora Flavescens Root Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis, Pistacia Lentiscus (Mastic) Gum , Salvia Officinalis, (Sage) Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis, Obtusa Oil, Propolis Extract, Charcoal Powder, Scutellaria Root Extract, Anethole, Hydroxyapatite, Silver

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-134580034488983GTIN-13: 4580034488983
EAN-13: 4580034488983
GTIN storage (14 digits): 04580034488983		finefra toothpaste carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69653-050-022022-07-29C16284748780-1e4f33bdf-9f27-d8a0-e053-dadaa90a6e4efd72829d-0d7d-4931-8ebc-2b8f1a97b406

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69653-050-01Finefra Tooth100 g in 1 TUBEPASTE, DENTIFRICE1003
69653-050-02Finefra Tooth1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69653-050FINEFRA TOOTH (SILICON DIOXIDE, ALCLOXA) PASTE, DENTIFRICE [JEWOO MEDICAL CO,.LTD]3Legacy NDC, 2 package rows20181129_fd72829d-0d7d-4931-8ebc-2b8f1a97b406.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
69653-05069653-050-01, 69653-050-02

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
6f5cc30b-aca8-4813-a553-81d47ab0b0d5fd72829d-0d7d-4931-8ebc-2b8f1a97b4062018-11-29WarningsExact identifier
spl id: 6f5cc30b-aca8-4813-a553-81d47ab0b0d5
spl set id: fd72829d-0d7d-4931-8ebc-2b8f1a97b406

Reported adverse events (FAERS/openFDA)#

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