Label: RITE AID EXTRA WHITENING- fluoride paste, dentifrice

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

Drug Label Information

Updated February 14, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
    • aids in the prevention of dental cavities
  • WARNINGS

    Warnings

    When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

    See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

    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.

  • DOSAGE & ADMINISTRATION

    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 one minute, preferably after each meal or least twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
    • Children under 12 years of age: consult a dentist or physician.
  • INACTIVE INGREDIENT

    Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

  • STORAGE AND HANDLING

    Store in a cool dry place. Keep tube capped when not in use.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    RITE AID, 30 HUNTER LANE

    CAMP HILL, PA 17011

    MADE IN USA

  • PRINCIPAL DISPLAY PANEL

    Carton R4

  • INGREDIENTS AND APPEARANCE
    RITE AID  EXTRA WHITENING
    fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-5020
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-5020-91 in 1 CARTON06/03/2013
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02206/03/2013
    Labeler - Rite Aid (014578892)
    Registrant - Lornamead (080046418)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lornamead080046418manufacture(11822-5020)
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