70602-002Exoden White Tooth_Deactivation

Drug Labeling and Warnings

Drug Details [pdf]

EXODEN WHITE TOOTH- domiphen bromide 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.

----------

70602-002Exoden White Tooth_Deactivation

Aminocaproic Acid 0.20%
Silica 5.00%

Oral Health Care

Aids in the 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

Purified Water, Carboxymethylcellulose Sodium, Citrus Paradisi (Grapefruit) Seed Extract, L-Menthol, Mentha Piperita (Peppermint) Oil, Anethole, Carvone, D-Sorbitol Solution, Mica, Polyethylene Glycol 1500, Glycerin, Cocamidopropyl Betaine, Stevioside, Titanium Dioxide, Allantoine Chlorohydroxy Aluminum, Sodium Benzoate, Aloevera Gel, Hydroxyapatite, Xylitol, Bamboo salt, Sophora Angustifolia Root Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Salicylic Acid, Chitosan, Protease, Propolis Extract, Tocopherol

EXODEN WHITE TOOTH 
domiphen bromide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70602-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206)	AMINOCAPROIC ACID	0.3 g  in 150 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	7.5 g  in 150 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
SORBITOL (UNII: 506T60A25R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MICA (UNII: V8A1AW0880)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
XYLITOL (UNII: VCQ006KQ1E)
STEVIOSIDE (UNII: 0YON5MXJ9P)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SALICYLIC ACID (UNII: O414PZ4LPZ)
PROPOLIS WAX (UNII: 6Y8XYV2NOF)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TOCOPHEROL (UNII: R0ZB2556P8)
CITRUS PARADISI SEED (UNII: 12F08874Y7)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PEPPERMINT OIL (UNII: AV092KU4JH)
ANETHOLE (UNII: Q3JEK5DO4K)
CARVONE, (+)- (UNII: 4RWC1CMS3X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70602-002-02	1 in 1 CARTON	04/07/2016	09/26/2019
1	NDC: 70602-002-01	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		04/07/2016	09/26/2019

Labeler - LIFEON Corp. (688528872)

Registrant - LIFEON Corp. (688528872)

Establishment
Name	Address	ID/FEI	Business Operations
LIFEON Corp.		688528872	manufacture(70602-002)

Revised: 9/2019

Document Id: 937cad2e-6c8f-3936-e053-2995a90a1b42

34390-5

Set id: 3fa8362f-e85a-4e16-98cb-3687b6a6b0e3

Version: 3

Effective Time: 20190926

 <