Label: EXODEN SENSITIVE- tricalcium phosphate, silicon dioxide paste
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Contains inactivated NDC Code(s)
NDC Code(s): 70602-006-01, 70602-006-02 - Packager: LIFEON Corp.
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated March 11, 2021
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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DOSAGE & ADMINISTRATION
Supervise children as necessary until capable of using without supervisionAdults and children 6 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 a physician
Children under 12 years: Instruct in good brushing and rinsing habits (to minimize swallowing)
Children under 6 years: Do not use unless directed by a dentist or a physician
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Glycerin, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Hydroxyapatite, Xylitol, Stevioside, Glycyrrhiza Extract, Protease, Sodium Chloride, Camomille Extract(1), Scutellaria Root Extract, Sage Extract, Gentiana Extract, Fennel Extract , Sodium Cocoyl Glutamate, Tocopheryl Acetate, Mastic Oil, Eucalyptus Globulus Leaf Oil, L-Menthol, Peppermint Oil, Anethole, Carvone, Chamaecyparis Obtusa Oil, Potassium nitrate, Purified Water
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EXODEN SENSITIVE
tricalcium phosphate, silicon dioxide pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70602-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 19 g in 100 g SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 2.5 g in 100 g Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) SORBITOL SOLUTION (UNII: 8KW3E207O2) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) XYLITOL (UNII: VCQ006KQ1E) GLUCOSYL STEVIOL (UNII: TKD5UC898Q) LICORICE (UNII: 61ZBX54883) SODIUM CHLORIDE (UNII: 451W47IQ8X) CHAMOMILE (UNII: FGL3685T2X) SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) CLARY SAGE (UNII: U3HSK5JC0Q) GENTIANA LUTEA ROOT (UNII: S72O3284MS) SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) EUCALYPTUS OIL (UNII: 2R04ONI662) LEVOMENTHOL (UNII: BZ1R15MTK7) PEPPERMINT OIL (UNII: AV092KU4JH) ANETHOLE (UNII: Q3JEK5DO4K) CARVONE, (+/-)- (UNII: 75GK9XIA8I) CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62) POTASSIUM NITRATE (UNII: RU45X2JN0Z) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70602-006-02 1 in 1 CARTON 03/11/2021 1 NDC:70602-006-01 120 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 03/11/2021 Labeler - LIFEON Corp. (688528872) Registrant - LIFEON Corp. (688528872) Establishment Name Address ID/FEI Business Operations Korea Life Science Co.,ltd 694914835 manufacture(70602-006)