Label: HANDY SOLUTIONS MINT FLUORIDE TOOTH- sodium fluoride paste

  • 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 June 21, 2015

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  • Drug Facts

  • Active ingredient

    Sodium Fluoride 0.25%

    Purpose

    Anticavity

  • Use

    helps protect against cavities

  • Warnings

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

    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center Immediately

  • Directions

    Adults and children 2 years and older. Brush teeth thoroughly after meals or at least twice a day or as directed by a dentist or physician. Children under 6 years: To minimize swallowing, use a pea sized amount and supervise brushing until good habits are established. Children under 2 years: Ask a dentist or physician

  • Inactive ingredients

    Water, Sorbitol, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Polyethylene Glycol-32, Flavor, Saccharin Sodium, Cellulose Gum, Titanium Dioxide, Sodium Benzoate.

  • Questions?

    Call 1-800-525-5097

  • Product Label

    Box

  • INGREDIENTS AND APPEARANCE
    HANDY SOLUTIONS MINT FLUORIDE TOOTH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-035
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67751-035-011 in 1 BOX
    178 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/21/2015
    Labeler - Navajo Manufacturing Co., Inc. (091917799)
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