Label: EXODEN WHITE TOOTH- domiphen bromide paste

  • NDC Code(s): 70602-002-01, 70602-002-02
  • Packager: LIFEON Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated May 9, 2018

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Aminocaproic Acid 0.20%
    Silica 5.00%

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  • PURPOSE

    Oral Health Care

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  • INDICATIONS & USAGE

    Aids in the cleanness of teeth and protection of gum health

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  • 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

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  • 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

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  • 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

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  • INACTIVE INGREDIENT

    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

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  • INGREDIENTS AND APPEARANCE
    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
    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
    Labeler - LIFEON Corp. (688528872)
    Registrant - LIFEON Corp. (688528872)
    Establishment
    Name Address ID/FEI Business Operations
    LIFEON Corp. 688528872 manufacture(70602-002)
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