Label: FINEFRA BLACK TOOTH- silicon dioxide, alcloxa paste, dentifrice
Contains inactivated NDC Code(s)
NDC Code(s): 69653-110-01, 69653-110-02
- Packager: Jewoo Medical Co,.Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated December 26, 2019
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- ACTIVE INGREDIENT
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
- KEEP OUT OF REACH OF CHILDREN
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:69653-110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 20.25 g in 135 g ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA 0.21 g in 135 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:69653-110-02 1 in 1 CARTON 12/01/2019 1 NDC:69653-110-01 135 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(69653-110)