Label: MAXIMUM SECURITY ANTICAVITY- sodium fluoride gel

  • 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 January 31, 2020

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  • Drug Facts

  • Active ingredient:

    Sodium Fluoride - 0.22% (0.1% w/ 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, Sodium Lauryl Sulfate, Carbomer, Sodium Saccharin, Sodium Hydroxide, PEG-40 Hydrogenated Castor Oil, Flavor, Sodium Benzoate

  • Package Labeling:

    Label

  • Package Labeling:

    Label2

  • INGREDIENTS AND APPEARANCE
    MAXIMUM SECURITY ANTICAVITY 
    sodium fluoride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53247-200
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.2 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53247-200-424.25 g in 1 PACKET; Type 0: Not a Combination Product01/29/2020
    2NDC:53247-200-13130 g in 1 TUBE; Type 0: Not a Combination Product01/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/29/2020
    Labeler - Bob Barker Company, Inc. (058525536)
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