Label: DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH- sodium fluoride 0.05% rinse

  • NDC Code(s): 84035-009-01
  • Packager: Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 15, 2024

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  • ACTIVE INGREDIENT

    Sodium fluoride 0.05%

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    Useaids in the prevention of dental cavities

  • WARNINGS

    WARNINGS: If more than used for brushing is accidentally swallowed, get medical help or contact poison control center right away.


  • Directions

    Adults and children of 6 years of age and older:

    • Use once a day after brushing your teeth with a toothpaste.
    •Remove cap
    • Hold bottle upright and squeeze
    •Pour out
    •Vigorously swish between your teeth for 1 minute and then spit out
    • Do not swallow the rinse.
    • Do not eat or drink for 30 minutes after rinsing.

  • OTHER SAFETY INFORMATION

    Store in a dry, cool place away from sunlight.

  • Inactive Ingredients

    Water, Glycerol, Ethoxylated Hydrogenated Rice Oil, Sorbitol, Aroma, Sodium Edetate, Sodium Benzoate, Cetylpyridinium Chloride, Sodium Phosphate Monobasic, Sodium Phosphate Dibasic, Sucralose, Brilliant Blue (CI 42090)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age

  • PRINCIPAL DISPLAY PANEL

    Packlabel

  • INGREDIENTS AND APPEARANCE
    DENTALCLEAN BLUE DIAMOND ALCOHOL FREE MOUTHWASH 
    sodium fluoride 0.05% rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-009
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84035-009-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02106/01/2024
    Labeler - Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda (901719567)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda901719567manufacture(84035-009)
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