FINEFRA KIDS 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 13.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

Inactive ingredients:

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Stevioside, Flavor, Cellulose Gum, Xylitol, Charcoal Powder, 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, Mika, Commiphora Myrrha Oil, Krameria Triandra Root Extract, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil

PURPOSE

Purpose: Anticavity

WARNINGS

Warnings:

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 REACH OF CHILDREN

Uses

Uses:

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

Directions

Directions:

children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a dentist or physician.: 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 KIDS TOOTH 
silicon dioxide, alcloxa paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE9.10 g  in 70 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.11 g  in 70 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69653-120-021 in 1 CARTON12/01/2019
1NDC:69653-120-0170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2019
Labeler - Jewoo Medical Co,.Ltd (689512541)
Registrant - Jewoo Medical Co,.Ltd (689512541)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(69653-120)

Revised: 12/2019
Document Id: 67525822-1f74-4a64-b66e-1f81b97ea058
Set id: 9c72338f-c4e0-4c3a-8361-9e2bdcff0c98
Version: 1
Effective Time: 20191226
 
Jewoo Medical Co,.Ltd