Label: DENTALCLEAN ULTRA REFRESHING EXTREME ICE DENTAL GEL- sodium fluoride 0.24% paste, dentifrice

  • NDC Code(s): 84035-001-01
  • Packager: Rabbit Indústria e Comércio de Produtos de Higiene Pessoal Ltda
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 26, 2024

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

View All Sections
  • 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

    • Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor
  • INACTIVE INGREDIENT

    Water, Glycerol, Silium Dioxide, Sorbitol, Sodium Lauryl Sulphate, Carmelose Sodium, Aroma, Menthol, Cetylpyridinium Chloride, Sodium Benzoate, Sucralose, Bright Blue (CI42090)

  • OTHER SAFETY INFORMATION

    Store in a dry, cool place away from sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DENTALCLEAN ULTRA REFRESHING EXTREME ICE DENTAL GEL 
    sodium fluoride 0.24% paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84035-001
    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)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    MENTHOL (UNII: L7T10EIP3A)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84035-001-011 in 1 CARTON06/01/2024
    150 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(84035-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!