EXODEN WHITE- silicon dioxide, aluminum chlorohydroxy allantoinate paste

Exoden White by

Drug Labeling and Warnings

Exoden White 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

Silicon dioxide 15%

Aluminum Chlorohydroxy Allantoinate 0.16%

PURPOSE

Anti plaque

Periodontal disease prevention

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, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXODEN WHITE 
silicon dioxide, aluminum chlorohydroxy allantoinate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70602-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCLOXA (UNII: 18B8O9DQA2) (ALLANTOIN - UNII:344S277G0Z)	ALCLOXA	0.16 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	15 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70602-008-02	1 in 1 CARTON	03/12/2021
1	NDC: 70602-008-01	150 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		03/12/2021

Labeler - LIFEON Corp. (688528872)

Registrant - LIFEON Corp. (688528872)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Life Science Co.,ltd		694914835	manufacture(70602-008)