Label: SAFETYMAXX MINT FLAVOR- sodium fluoride gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 November 15, 2011

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  • Active Ingredient

    Sodium Fluoride - 0.22% (0.1%w/v fluoride ion)

  • Purpose

    Anticavity

  • Use:

    Helps protect against cavities

  • Warnings

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

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

  • Directions

    Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.

    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

    Purified water, Sorbitol, Carbopol, Sodium Lauryl Sulphate, Flavor, Poly Ethylene Glycol 1500, Sodium Saccharin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Methyl Paraben, Propyl Paraben

  • SPL UNCLASSIFIED SECTION

    Product of China, Exclusively produced for FSi, Inc. 1-800-647-5923 www.myfsi.net Expires 2 years from the DAte of Mfg

    FSi, Inc Nashville TN 37210

  • Product Tube Label

    SafetyMaxx Toothgel

  • INGREDIENTS AND APPEARANCE
    SAFETYMAXX MINT FLAVOR 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60371-344
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60371-344-0617 g in 1 TUBE
    2NDC:60371-344-8524 g in 1 TUBE
    3NDC:60371-344-1543 g in 1 TUBE
    4NDC:60371-344-46130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/15/2011
    Labeler - FSi, Inc. (609296694)
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