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
- 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 March 11, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- 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)
