Label: GUM DETOXIFY- stannous fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 14, 2024

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  • ACTIVE INGREDIENT

    Stannous fluoride 0.454% (0.14% w/v fluoride ion)

  • PURPOSE

    Anticavity/Antigingivitis

  • INDICATIONS & USAGE

    aids in the prevention of cavities * helps prevent gingivitis * helps interfere with the harmful effects of plaque associated with gingivitis * helps control plaque bacteria that contribute to the development of gingivitis

  • WARNINGS

    Keep out of reach of children under 12 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    adults and children 12 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist of physician * do not swallow * children under 12 years of age: ask a dentist

  • OTHER SAFETY INFORMATION

    products containing stannous fluoride may produce surface staining of the teeth * adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist * this product is specifically formulated to help prevent staining * see your dentist regularly

  • INACTIVE INGREDIENT

    water, hydrated silica, sorbitol, sodium lauryl sulfate, carrageenan, flavor, xanthan gum, zinc citrate, sodium saccharin, sodium hydroxide, sucralose, titanium dioxide

  • PRINCIPAL DISPLAY PANEL

    Carton R1

  • INGREDIENTS AND APPEARANCE
    GUM DETOXIFY 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5006
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5006-91 in 1 CARTON11/10/2021
    1116.2 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/10/2021
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11822-5006) , pack(11822-5006)
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