Drug Labeling and Warnings

Drug Details

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FINEFRA BLACK 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, 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

Image of carton

FINEFRA BLACK TOOTH 
silicon dioxide, alcloxa paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69653-100
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: 69653-100-021 in 1 CARTON12/01/2019
1NDC: 69653-100-01100 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/2019
Labeler - Jewoo Medical Co,.Ltd (689512541)
Registrant - Jewoo Medical Co,.Ltd (689512541)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(69653-100)

Revised: 12/2019
 
Jewoo Medical Co,.Ltd


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