Label: RITE AID ANTI-CAVITY, ANTI-GINGIVITIS- stannous fluoride paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 8, 2010

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  • Active Ingredient

    STANNOUS FLUORIDE 0.454%................ANTICAVITY, ANTIGINGIVITIS
    (.016% WITH FLUORIDE ION)                   antisensitivity toothpaste
  • PURPOSE


  • KEEP OUT OF REACH OF CHILDREN


  • USE

    Helps aid in the prevention of cavities.

    • Helps prevent gingivitis.
    • Helps control plaque bacteria that contribute to the development of gingivitis.
    • Builds increasing protection against painful sensitivity of the health to cold, heat, acids, sweets or contact.
  • WARNINGS

    When using this product do not use for sensitivity

    longer than four weeks unless recommended by dentist.

    Stop use and ask a dentist if the sensitivity problem persists or

    worsens.  Sensitive teeth may indicate a serious problem.

  • Directions

    Adults and children      Brush teeth thoroughly, preferably after

    12 years and older       each meal, or at least twice a day, or as

                                          directed by your dentist.  Do not swallow.

    Children under 12         Ask a dentist or physician

    OTHER INFORMATION   Products containing stannous fluoride

    may produce surface staining of the teeth.  Adequate toothbrushing

    may prevent these stains which are not harmful or perment.

  • Inactive ingredients:

    Sorbitol, Water, Hydrated Silica, Sodium Hexametaphosphate, Glycerin, Sodium Lauryl Sulfate, Zinc Lactate, PEG-6, Cellulose Gum, Sodium Phosphate, Sodium Gluconate, Saccharin Sodium, Titanium Dioxide, Blue 1, Yellow 4

  • PRINCIPAL DISPLAY PANEL

    image of container

  • INGREDIENTS AND APPEARANCE
    RITE AID ANTI-CAVITY, ANTI-GINGIVITIS  
    stannous fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Stannous Fluoride (UNII: 3FTR44B32Q) (Fluoride Ion - UNII:Q80VPU408O) Stannous Fluoride4.54 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Clean Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-0001-1170 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/08/2010
    Labeler - Rite Aid (014578892)
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