EXODEN WHITE- silicon dioxide, aluminum chlorohydroxy allantoinate 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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70602-008_Exoden White Toothpaste

Silicon dioxide 15%

Aluminum Chlorohydroxy Allantoinate 0.16%

Anti plaque

Periodontal disease prevention

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, Cocamidopropyl Betaine, Sodium Benzoate, Stevioside, Xylitol, Sodium Chloride, Protease, Chitosan, Propolis Extract, Glycyrrhiza Extract, Aloe Vera Gel, Tocopherol, L-Menthol, Peppermint Oil, Carvone, Anethole, Titanium Oxide, Mika, Purified Water

image description

EXODEN WHITE 
silicon dioxide, aluminum chlorohydroxy allantoinate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70602-008
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
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL SOLUTION (UNII: 8KW3E207O2)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
GLUCOSYL STEVIOL (UNII: TKD5UC898Q)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CHITOSAN LOW MOLECULAR WEIGHT (20-200 MPA.S) (UNII: SBD1A2I75N)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
LICORICE (UNII: 61ZBX54883)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LEVOMENTHOL (UNII: BZ1R15MTK7)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CARVONE, (+/-)- (UNII: 75GK9XIA8I)  
ANETHOLE (UNII: Q3JEK5DO4K)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70602-008-021 in 1 CARTON03/12/2021
1NDC:70602-008-01150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/12/2021
Labeler - LIFEON Corp. (688528872)
Registrant - LIFEON Corp. (688528872)
Establishment
NameAddressID/FEIBusiness Operations
Korea Life Science Co.,ltd694914835manufacture(70602-008)

Revised: 3/2021
Document Id: bd61a510-2d72-3970-e053-2a95a90a5af2
Set id: 7d43d35b-4663-4483-9362-94d23bc17ea0
Version: 1
Effective Time: 20210312
 
LIFEON Corp.