FINEFRA BLACK TOOTH- silicon dioxide, alcloxa paste, dentifrice

Finefra Black Tooth by

Drug Labeling and Warnings

Finefra Black Tooth by is a Otc medication manufactured, distributed, or labeled by Jewoo Medical Co,.Ltd, Korea Life Science Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Silica 15.00%, Alcloxa 0.16%

INACTIVE INGREDIENT

Inactive ingredients:

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, Cellulose Gum, Mentha Piperita (Peppermint) Oil, Sophora Angustifolia Root Extract, Charcoal Powder, Xylitol, Menthol, Stevioside, Chamaecyparis Obtusa Oil, Eucalyptus Globulus Leaf Oil, Carvone, Anethole, Hydroxyapatite, 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, Silver, Mika, Commiphora Myrrha Oil, Krameria Triandra Root Extract

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

INGREDIENTS AND APPEARANCE

FINEFRA BLACK TOOTH 
silicon dioxide, alcloxa paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69653-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15.0 g  in 100 g
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z)	ALCLOXA	0.16 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69653-100-02	1 in 1 CARTON	12/01/2019
1	NDC: 69653-100-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2019

Labeler - Jewoo Medical Co,.Ltd (689512541)

Registrant - Jewoo Medical Co,.Ltd (689512541)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Life Science Co.,ltd		694914835	manufacture(69653-100)