MEDIF TOOTH- silicon dioxide, alcloxa paste, dentifrice 
MEDIF CO.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active ingredients: SILICON DIOXIDE 14.0%, ALCLOXA 0.05%

INACTIVE INGREDIENT

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

Purpose: Anticarries

WARNINGS

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

Keep out of the reach of children under 6 years of age.

Uses

Uses: Helps protect against cavities.

Directions

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 carton

MEDIF TOOTH 
silicon dioxide, alcloxa paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72346-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE18.20 g  in 130 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.06 g  in 130 g
Inactive Ingredients
Ingredient NameStrength
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72346-010-021 in 1 CARTON05/01/2018
1NDC:72346-010-01130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2018
Labeler - MEDIF CO.,LTD (694955391)
Registrant - MEDIF CO.,LTD (694955391)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO., LTD.557810721manufacture(72346-010)

Revised: 11/2023
Document Id: eb1dc942-6ab1-4cc2-942e-3395527edb3a
Set id: a56d669c-624d-46cf-b3f7-6a43fd63a9f6
Version: 2
Effective Time: 20231124
 
MEDIF CO.,LTD