Label: DENTALCLEAN REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE- sodium fluoride 0.24% paste, dentifrice

  • NDC Code(s): 84035-002-03
  • Packager: Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 1, 2024

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  • ACTIVE INGREDIENT

    Sodium fluoride 0.24%

  • 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 2 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 doctor.

    • Children 2 to 6 years of age: instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children under 6 years as necessary and use a pea-sized amount until your child is capable of using without supervision.

    • Children under 2 years of age: do not use unless directed by a dentist or doctor or as directed by a dentist or doctor.

  • OTHER SAFETY INFORMATION

    Store in a dry, cool place away from sunlight.

  • INACTIVE INGREDIENT

    Glycerol, Silium Dioxide, Sorbitol, Water, Sodium Lauryl Sulphate, Aroma, Carmelose Sodium, Phoshoric Acid, Tetrassodium Pyrophosphate, Menthol, Mica, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose

  • 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 REGENERATOR SENSITIVE DENTAL GEL WITH FLOURIDE 
    sodium fluoride 0.24% paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    CETYLPYRIDINIUM CHLORIDE ANHYDROUS (UNII: 6BR7T22E2S)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SORBITOL (UNII: 506T60A25R)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    MICA (UNII: V8A1AW0880)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84035-002-031 in 1 CARTON06/01/2024
    1104 g in 1 TUBE; Type 0: Not a Combination Product
    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(84035-002)
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