Label: COMPLETE PROTECTION- stannous fluoride paste, dentifrice

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

Drug Label Information

Updated November 28, 2023

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 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.

  • Keep out of reach of children

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

  • Directions

    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.
  • Other 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 ingredients

    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 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-366
    Route of AdministrationORAL, DENTAL
    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
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    Product Characteristics
    Colorwhite (White to off white) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-366-091 in 1 CARTON02/10/2024
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11673-366-191 in 1 CARTON02/10/2024
    2226 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/10/2024
    Labeler - Target (006961700)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11673-366) , pack(11673-366)