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

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated February 22, 2024

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  • ACTIVE INGREDIENT

    Stannous Fluoride 0.454% w/w (0.15% w/v fluoride ion) ...... Acticavity, Antigingivitis, Anithypersensitivity

  • DOSAGE & ADMINISTRATION

    Aids in the prevention of dental cavities. Helps interfere with the harmful effects of plaque associated with gingivitis. Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

  • INDICATIONS & USAGE

    Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: consult a dentist or doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a poision control center right away.

  • PURPOSE

    Products containing stannous fluoride may produce surface staining of the teeth. Adquate 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 prevent staining. Store below 30C or 86F.

  • WARNINGS

    When using this product, if irritation occurs discontinue use. Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. Pain/sensitivity still persists after 4 weeks of use. Gingivitis, bleeding, or redness persists for more than 2 weeks. You have painful or swollen gums, pus from the gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

  • INACTIVE INGREDIENT

    glycerin, water, hydrated silica, petasodium tryiphosphate, flavor, sodium lauryl sulfate, titanium dioxide, cellulose gum, cocamiodpropyl betaine, sodium saccharin.

  • PRINCIPAL DISPLAY PANEL

    5820060

  • INGREDIENTS AND APPEARANCE
    RITE AID SENSITIVITY AND GUM 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5060
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5060-91 in 1 BOX11/11/2022
    196.4 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(11822-5060) , pack(11822-5060)