FDA.reportPublic FDA data

MediF Tooth

Manufacturer
MEDIF CO.,LTD | DONG IL PHARMS CO., LTD.
Effective date
2023-11-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:20:10

Label at a glance#

ProductMediF Tooth
Active ingredientSILICON DIOXIDE, ALCLOXA
Label structure8 sections

Indications and uses

Uses: Helps protect against cavities.

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: SILICON DIOXIDE 14.0%, ALCLOXA 0.05%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: D-Sorbitol Solution, Propolis Powder, Concentrated Glycerin, Sodium Cocoyl Glutamate, Xantangum, L-Menthol, Peppermint Oil, Charcoal, Grapefruit Seed Extract, Hydroxyapatite, Xylitol, Anetol Oil, Glucosyl Stevia, Chamomile Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Glycyrrhiza Extract Powder, Silver foil, Water

PURPOSE

OTC - PURPOSE SECTION

Purpose: Anticarries

WARNINGS

WARNINGS SECTION

Warnings: Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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: Helps protect against cavities.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72346-010-022025-03-10C16284748780-12cef2736-694e-d83d-e063-dadaa90ab31fa56d669c-624d-46cf-b3f7-6a43fd63a9f6
72346-010-022025-01-30C16284748780-12cef2736-694e-d83d-e063-dadaa90ab31fa56d669c-624d-46cf-b3f7-6a43fd63a9f6

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72346-01072346-010-01, 72346-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
ALCLOXA18B8O9DQA2ACTIB
PROPOLIS WAX6Y8XYV2NOFIACT

Source Document#

Source XML · Source PDF

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
2ff7be20-dafa-cbf6-e063-6394a90ab95aa56d669c-624d-46cf-b3f7-6a43fd63a9f62025-03-10WarningsExact identifier
spl set id: a56d669c-624d-46cf-b3f7-6a43fd63a9f6

Reported adverse events (FAERS/openFDA)#

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