FINEFRA SILVER- sodium monofluorophosphate paste, dentifrice

Finefra Silver by

Drug Labeling and Warnings

Finefra Silver by is a Otc medication manufactured, distributed, or labeled by Jewoo Medical Co,.Ltd, NEO-MEDICALFARM CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient: Sodium Monofluorophosphate 0.76%

INACTIVE INGREDIENT

Inactive ingredients: Silica, Dental type silica, 6-Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, Glycerin, Polyethylene Glycol 1500, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Xylitol, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, L-Menthol, Peppermint Oil, Carvone, Anethole, Silver, Mica, CI 42090, Purified Water

PURPOSE

Purpose : Anticavity

WARNINGS

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

INDICATIONS & USAGE

Indications & usage: help protect against gum disease and cavities.

DOSAGE & ADMINISTRATION

Dosage & administration: 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

INGREDIENTS AND APPEARANCE

FINEFRA SILVER 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69653-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69653-020-01	100 g in 1 CARTON; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/01/2015

Labeler - Jewoo Medical Co,.Ltd (689512541)

Registrant - Jewoo Medical Co,.Ltd (689512541)

Establishment
Name	Address	ID/FEI	Business Operations
NEO-MEDICALFARM CO.,LTD		694914835	manufacture(69653-020)