Label: MAXIMUM SECURITY- sodium fluoride gel, dentifrice

  • NDC Code(s): 53247-132-01, 53247-132-02, 53247-132-03, 53247-132-04, view more
    53247-132-05
  • Packager: Bob Barker Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts:

  • ACTIVE INGREDIENT

    Sodium Fluoride - 0.22% (0.1% W/V fluoride ion)

  • PURPOSE

    Anticavity toothpaste

  • Use

    Helps protect against cavities.

  • Warnings

    Keep out of the 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 immediately.

  • Directions

    Adults & Children 6 years of age & 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:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
    Children under 2 years:Ask a dentist or physician.
  • Inactive ingredients

    Water, Sorbitol, Carbomer, Sodium Lauryl Sulfate, Flavor, Sodium Hydroxide, Sodium Saccharin, Disodium EDTA, Sodium Benzoate

  • SPL UNCLASSIFIED SECTION

    Dist. by Bob Barker Co. Inc. Fuquay-Varina, NC 27526

  • PRINCIPAL DISPLAY PANEL - 17 g Tube Label

    MAXIMUM®
    SECURITY

    ANTICAVITY
    GEL TOOTHPASTE

    Sodium Fluoride 0.22%

    Fresh Mint Flavor

    NET WT 0.6 OZ (17 g)

    Principal Display Panel - 17 g Tube Label
  • INGREDIENTS AND APPEARANCE
    MAXIMUM SECURITY 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-132
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sorbitol (UNII: 506T60A25R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53247-132-014.3 g in 1 PACKET; Type 0: Not a Combination Product01/01/2008
    2NDC:53247-132-0217 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    3NDC:53247-132-0324 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    4NDC:53247-132-0443 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    5NDC:53247-132-05130 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02101/01/2008
    Labeler - Bob Barker Company Inc. (058525536)
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