Label: RITE AID PRO DEFENSE WHITENING- stannous fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Stannous fluoride 0.454% (w/w)

  • PURPOSE

    Purpose

    Anticavity / Anti-gingivitis

  • INDICATIONS & USAGE

    Uses

    • aids in the prevention of dental cavities
    • helps control bleeding gums
    • helps interfere with harmful effects of plaque associated with gingivitis
  • WARNINGS

    Warnings

    Stop use and ask a dentist if:

    • gingivitis, bleeding or redness persists for more than 2 weeks
    • if you have painful or swollen gums, pus from the gum line, loose teeth or increasing space between teeth. These may be symptoms of periodontis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and older: brush teeth thoroughly, preferably after each meal or at least twice a day, and not more than 3 times a day or as day or as directed by a dentist or doctor. Minimize swallowing. Spit out after brushing

    • To minimize swallowing for children under 6 years of age, use a pea-sized amount and supervise brushing until good habits are established
    • Children under 2 years of age: consult a dentist or doctor.
  • STORAGE AND HANDLING

    Other information

    • products containing stannous fluoride may cause surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful or permanent and may be removed your dentist.
    • This product is specifically formulated to help prevent staining
    • store below 77°F (25°C)
    • Keep tube capped when not in use.
  • INACTIVE INGREDIENT

    Inactive ingredients Glycerin, Water, Hydrated Silica, Pentasodium Triphosphate, Cellulose Gum, Cocamidopropyl Betaine, Titanium Dioxide, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    RITE AID

    30 HUNTER LANE

    CAMP HILL, PA 17011

  • PRINCIPAL DISPLAY PANEL

    RITE AID® PHARMACY

    oral care

    pro defense

    daily fluoride anticavity & anti-gingivitis toothpaste

    whitening

    NET WT 3.4 OZ (96.4 g)

    RA PRO DEFENSE 2821284R1

  • INGREDIENTS AND APPEARANCE
    RITE AID PRO DEFENSE   WHITENING
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6034
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.454 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-6034-91 in 1 CARTON03/03/2019
    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 not finalpart35603/03/2019
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead Inc. (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead Inc.080046418manufacture(11822-6034)
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