Label: RITE AID GUM AND ENAMEL REPAIR- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated February 22, 2024

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  • ACTIVE INGREDIENT

    Stannous Fluoride 0.454%

    (0.14% w/v fluoride ion) ..... Anticavity, Antigingivitis

  • DOSAGE & ADMINISTRATION

    Aids in the prevention of cavities. Helps prevent gingivitis. Helps interfere with the harmful effects of plaque associated with gingivitis. Helps control plauqe bacteria that contribute to the development of gingivitis.

  • WARNINGS

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

  • INDICATIONS & USAGE

    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 or physician. Do not swallow. Children under 12 years of age: ask a dentist.

  • INACTIVE INGREDIENT

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

  • PURPOSE

    Products containing stannous fluoride may product surface staining of the teeth. Adequate tooth brushing may prevent these stains whcih 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chidlren under 12 years of age.

  • PRINCIPAL DISPLAY PANEL

    5820061

  • INGREDIENTS AND APPEARANCE
    RITE AID GUM AND ENAMEL REPAIR 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5061
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5061-91 in 1 BOX11/11/2022
    1116 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02111/11/2022
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11822-5061) , pack(11822-5061)
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