Label: COMPLETE PROTECTION TP- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated February 14, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Stannous fluoride 0.454% w/w (0.15% w/v fluoride ion)

  • PURPOSE

    Anticavity, Antigingivitis, Antihypersensitivity

  • INDICATIONS & USAGE

    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

  • WARNINGS

    When using this product, if irritation occurs discontinue use.

    Stop use and ask a dentist if: * the problems 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 teh gum line, loose teeth, or increasing space between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

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

  • DOSAGE & ADMINISTRATION

    adults and children 12 years of age adn 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.

  • 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. * store below 30*C (86*F)

  • INACTIVE INGREDIENT

    glycerin, water, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, cocamidopropyl betaine, sodium saccharin

  • PRINCIPAL DISPLAY PANEL

    Carton R1

  • INGREDIENTS AND APPEARANCE
    COMPLETE PROTECTION TP 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5005
    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
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5005-91 in 1 CARTON10/26/2021
    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 DrugM02110/26/2021
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11822-5005) , pack(11822-5005)