EXODEN SENSITIVE- tricalcium phosphate, silicon dioxide paste 
LIFEON Corp.

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.

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70602-006_Exoden Sensitive Toothpaste

Tricalcium Phosphate 19%

Silicon dioxide 2.5%

Anti plaque

Aids in cleanness of teeth and protection of gum health


Supervise children as necessary until capable of using without supervision

Adults 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

Ask a dentist before use if you have
• bleeding or redness lasting more than 2 weeks
• pain, swelling, pus, loose teeth, or more spacing between teeth
These may be signs of periodontitis, a serious form of gum disease

Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

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

image description

EXODEN SENSITIVE 
tricalcium phosphate, silicon dioxide paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70602-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICALCIUM PHOSPHATE (UNII: K4C08XP666) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION19 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE2.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70602-006-021 in 1 CARTON03/11/2021
1NDC:70602-006-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/11/2021
Labeler - LIFEON Corp. (688528872)
Registrant - LIFEON Corp. (688528872)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(70602-006)

Revised: 3/2021
Document Id: bd4d9401-3f6a-99a1-e053-2a95a90a6546
Set id: caf9e444-2594-4c6a-94a7-d3d9ccd6fbb1
Version: 1
Effective Time: 20210311
 
LIFEON Corp.