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.

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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
LIFEON Corp.