EXODEN CAVITY- silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate 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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70602-005_Exoden Cavity Toothpaste

Silicon dioxide 15%

Alcloxa 0.16%

Sodium Monofluorophosphate 0.76%

Anti plaque

Periodontal disease prevention

Anti-cavity

Aids in prevention of dental cavities


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, Dental-Type Silica, Hydrated Silicon Dioxide, Xylitol, Glucosyl Stevioside, Protease, Lemon Extract, Lime Extract, Sodium Chloride, Tricalcium Phosphate, Potassium nitrate, Sodium Cocoyl Glutamate, Propolis Extract, Green Tea Extract, Mastic Oil, Chamaecyparis Obtusa Oil, Peppermint Oil, Eucalyptus Globulus Leaf Oil, L-Menthol, Titanium Oxide, Purified Water

image description

EXODEN CAVITY 
silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70602-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z) ALCLOXA0.16 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE15 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 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)  
LEMON (UNII: 24RS0A988O)  
LIME (CITRUS) (UNII: 8CZS546954)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMAECYPARIS OBTUSA WOOD OIL (UNII: P2OMP71Y62)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70602-005-021 in 1 CARTON03/10/2021
1NDC:70602-005-01120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/10/2021
Labeler - LIFEON Corp. (688528872)
Registrant - LIFEON Corp. (688528872)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(70602-005)

Revised: 3/2021
Document Id: bd39f80a-f7cb-4fae-e053-2a95a90a08d7
Set id: 2d9e8559-1e92-464e-92de-981156975d9d
Version: 1
Effective Time: 20210310
 
LIFEON Corp.