EXODEN CAVITY- silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate paste

Exoden Cavity by

Drug Labeling and Warnings

Exoden Cavity 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%

Alcloxa 0.16%

Sodium Monofluorophosphate 0.76%

PURPOSE

Anti plaque

Periodontal disease prevention

Anti-cavity

INDICATIONS & USAGE

Aids in prevention of dental cavities

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, 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EXODEN CAVITY 
silicon dioxide, aluminum chlorohydroxy allantoinate, sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70602-005
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
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 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)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70602-005-02	1 in 1 CARTON	03/10/2021
1	NDC: 70602-005-01	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		03/10/2021

Labeler - LIFEON Corp. (688528872)

Registrant - LIFEON Corp. (688528872)

Establishment
Name	Address	ID/FEI	Business Operations
Korea Life Science Co.,ltd		694914835	manufacture(70602-005)