FINEFRA TOOTH- silicon dioxide, alcloxa paste, dentifrice 
Jewoo Medical 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: Silica 15.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

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

Purpose: Anticavity

WARNINGS

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

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

Uses

Uses:

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

Directions

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 carton

FINEFRA TOOTH 
silicon dioxide, alcloxa paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15.0 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.16 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69653-050-021 in 1 CARTON05/01/2018
1NDC:69653-050-01100 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 - Jewoo Medical Co,.Ltd (689512541)
Registrant - Finefrajapan Co.,ltd. (693542047)
Establishment
NameAddressID/FEIBusiness Operations
NEO-MEDICALFARM CO.,LTD694914835manufacture(69653-050)

Revised: 11/2018
Document Id: 6f5cc30b-aca8-4813-a553-81d47ab0b0d5
Set id: fd72829d-0d7d-4931-8ebc-2b8f1a97b406
Version: 3
Effective Time: 20181129
 
Jewoo Medical Co,.Ltd