Label: FINEFRA CLINIC TOOTH 135G- sodium monoflurophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69653-040-01, 69653-040-02 - Packager: Jewoo Medical Co,.Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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
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INACTIVE INGREDIENT
Inactive ingredients:
D-Sorbitol Solution, Silica, Purified Water, Dentaltype Silica, Glycerin, Mika, Sodium Cocoyl Glutamate, Mentha Piperita (Peppermint) Oil, Carboxymethylcellulose Sodium, Stevioside, Charcoal Powder, Menthol, Xylitol, Allantoine Chlorohydroxy Aluminum, Aminocaproic Acid, Glycyrrhiza, Glabra (Licorice) Root Extract, Gentiana Lutea Root Extract, Sophora, Flavescens Root Extract, Lavandula Angustifolia Extract, Rhatany Tincture, Rosemary Extract, Mastic Oil, Myrrh Tincture, Salvia Officinalis (Sage) Extract, Anethole, Aloe Barbadensis Leaf Extract, Eucalyptus Oil, Chamomilla Recutita (Matricaria) Flower Extract, Chitosan, Chamaecyparis Obtusa Oil, Propolis Extract, Scutellaria Root Extract, Carvone, Silver, Hydroxyapatite
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
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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
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INGREDIENTS AND APPEARANCE
FINEFRA CLINIC TOOTH 135G
sodium monoflurophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69653-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.02 g in 135 g Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69653-040-02 1 in 1 CARTON 05/01/2018 1 NDC:69653-040-01 135 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 OTC monograph final part355 05/01/2018 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(69653-040)
