Label: MAXIMUM SECURITY- sodium fluoride gel, dentifrice

  • NDC Code(s): 53247-122-01, 53247-122-02, 53247-122-03, 53247-122-04, view more
    53247-122-05, 53247-122-06
  • Packager: Bob Barker Company Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 30, 2023

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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

    Sorbitol, Water, Hydrated Silica, Glycerin, Cellulose Gum, Sodium Lauryl Sulfate, Polyethylene Glycol, Sodium Benzoate, Flavor, Sodium Saccharin

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 24 g Tube Label

    MAXIMUM®
    SECURITY

    ANTICAVITY
    GEL TOOTHPASTE

    Sodium Fluoride 0.22%

    Fresh Mint Flavor

    NET WT 0.85 OZ. (24 g)

    PRINCIPAL DISPLAY PANEL - 24 g Tube Label
  • INGREDIENTS AND APPEARANCE
    MAXIMUM SECURITY 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-122
    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
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrated Silica (UNII: Y6O7T4G8P9)  
    Glycerin (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Polyethylene Glycol 1600 (UNII: 1212Z7S33A)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53247-122-014.3 g in 1 PACKET; Type 0: Not a Combination Product01/01/2008
    2NDC:53247-122-0217 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    3NDC:53247-122-0324 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    4NDC:53247-122-0443 g in 1 TUBE; Type 0: Not a Combination Product01/01/2008
    5NDC:53247-122-0578 g in 1 TUBE; Type 0: Not a Combination Product01/01/200810/25/2023
    6NDC:53247-122-06130 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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