Label: CLOSEUP TRAVEL- sodium fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated August 10, 2022

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  • ACTIVE INGREDIENTS

    Sodium Fluoride 0.21%

  • PURPOSE

    Anticavity

  • USE

    Aids in the prevention of dental cavities

  • WARNING

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • DIRECTIONS

    Do not swallow.

    • Adults and children 2 years and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

    • Children under 6 Years of Age: Use only a pea-sized amount and supervise children's brushing and rinsing to minimize swallowing.

    • Children under 2 years of age: Ask a dentist or physician
  • INACTIVE INGREDIENTS

    Sorbitor, Water, Silica, Sodium Lauryl Suphate, PEG-32, Titanium Dioxide, Flavor, Cellulose Gum, Cocamidopropyl Betaine, Sodium Saccharin, Zinc Sulfate, Sodium Hydroxide, D&C Red 33, FD&C Red 40, Synthetic Fluorphlogopite, Melaleuca Alternifolia (Tea Tree Extract), Eucalyptus Globulus (Eucalyptus Extract), Eugenol

  • QUESTIONS

    1-866-421-0309

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL FRONTPRINCIPAL DISPLAY PANEL BACK

  • INGREDIENTS AND APPEARANCE
    CLOSEUP TRAVEL 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70708-182
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS GLOBULUS WHOLE (UNII: SI1P2XF3M3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    EUGENOL (UNII: 3T8H1794QW)  
    MELALEUCA ALTERNIFOLIA WHOLE (UNII: 976KV4FXYF)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    ZINC SULFATE (UNII: 89DS0H96TB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ALPHA CELLULOSE (UNII: I355QGZ19A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PEG-32 LAURATE (UNII: F8XJF81O0F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70708-182-011 in 1 POUCH08/01/2022
    1NDC:70708-182-8080 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35508/01/2022
    Labeler - GURUNANDA, LLC (079671169)
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