FINEFRA CLINIC TOOTH 135G- sodium monoflurophosphate paste, dentifrice 
Jewoo Medical Co,.Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

Active ingredients: Sodium Monofluorophosphate 0.76%

INACTIVE INGREDIENT

Inactive ingredients:

D-Sorbitol Solution, Silica, Purified Water, Dentaltype Silica, Glycerin, Mika, Sodium Cocoyl Glutamate, Mentha Piperita (Peppermint) Oil, Carboxymethylcellulose Sodium, Stevioside, Charcoal Powder, Menthol, Xylitol, Allantoine Chlorohydroxy Aluminum, Aminocaproic Acid, Glycyrrhiza, Glabra (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora, Flavescens Root Extract, Lavandula Angustifolia Extract, Rhatany Tincture, Rosemary Extract, Mastic Oil, Myrrh Tincture, Salvia Officinalis (Sage) Extract, Anethole, Aloe Barbadensis Leaf Extract, Eucalyptus Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis Obtusa Oil, Propolis Extract, Scutellaria Root Extract, Carvone, Silver, Hydroxyapatite

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 CLINIC TOOTH  135G
sodium monoflurophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69653-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.02 g  in 135 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69653-040-021 in 1 CARTON05/01/2018
1NDC:69653-040-01135 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2018
Labeler - Jewoo Medical Co,.Ltd (689512541)
Registrant - Jewoo Medical Co,.Ltd (689512541)
Establishment
NameAddressID/FEIBusiness Operations
NEO-MEDICALFARM CO.,LTD694914835manufacture(69653-040)

Revised: 11/2018
Document Id: 4d9f8b6f-c87d-4960-9934-5dd7286878bb
Set id: 7e263d3f-5504-4ff6-85a7-fc7723a3117d
Version: 3
Effective Time: 20181129
 
Jewoo Medical Co,.Ltd