EXODEN SENSITIVE- tricalcium phosphate, silicon dioxide paste

Exoden Sensitive by

Drug Labeling and Warnings

Exoden Sensitive by is a Otc medication manufactured, distributed, or labeled by LIFEON Corp., Korea Life Science Co.,ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Tricalcium Phosphate 19%

Silicon dioxide 2.5%

PURPOSE

Anti plaque

INDICATIONS & USAGE

Aids in cleanness of teeth and protection of gum health

DOSAGE & ADMINISTRATION

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

WARNINGS

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

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

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

INGREDIENTS AND APPEARANCE

EXODEN SENSITIVE 
tricalcium phosphate, silicon dioxide paste

Product 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)