Label: FINEFRA TOOTH- silicon dioxide, alcloxa paste, dentifrice
Contains inactivated NDC Code(s)
NDC Code(s): 69653-050-01, 69653-050-02
- 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.
Drug Label Information
Updated November 29, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
Sorbitol, Water, Glycerin, Mica, Sodium Cocoyl Glutamate, Mentha Piperita, (Peppermint) Oil, Cellulose Gum, Stevioside, Menthol, Xylitol, Glycyrrhiza, Uralensis (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora Flavescens Root Extract, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis, Pistacia Lentiscus (Mastic) Gum , Salvia Officinalis, (Sage) Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis, Obtusa Oil, Propolis Extract, Charcoal Powder, Scutellaria Root Extract, Anethole, Hydroxyapatite, Silver
- 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
silicon dioxide, alcloxa paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69653-050 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:69653-050-02 1 in 1 CARTON 05/01/2018 1 NDC:69653-050-01 100 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 05/01/2018 Labeler - Jewoo Medical Co,.Ltd (689512541) Registrant - Finefrajapan Co.,ltd. (693542047) Establishment Name Address ID/FEI Business Operations NEO-MEDICALFARM CO.,LTD 694914835 manufacture(69653-050)