Label: FINEFRA SILVER- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 69653-020-01 - 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: Silica, Dental type silica, 6-Aminocaproic Acid, Allantoine Chlorohydroxy Aluminum, Glycerin, Polyethylene Glycol 1500, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Xylitol, Saccharin Sodium, Sodium Benzoate, Sodium Lauryl Sulfate, L-Menthol, Peppermint Oil, Carvone, Anethole, Silver, Mica, CI 42090, Purified Water
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Dosage & administration: adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). children under 2 years: ask a dentist or physician.
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FINEFRA SILVER
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69653-020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.76 g in 100 g Inactive Ingredients Ingredient Name Strength Glycerin (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69653-020-01 100 g in 1 CARTON; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 03/01/2015 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(69653-020)
