Label: REXALL RESTORE AND DEFEND SENSITIVE WHITENING- stannous fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated March 23, 2022

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  • ​Drug Facts

  • ​Active ingredient

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

  • ​Purpose

    Anticavity, Antihypersensitivity

  • 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

    ​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

    ​Keep out of reach of children under 12 years of age. ​If more than amount used for brushing is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

  • ​Directions

    ​Adult and children 12 years & older: ​apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly for at least one minute, twice a day (morning and evening) and not more than 3 times a day or as recommended by a dentist or physician. 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. Store at room temperature 68-77°F (20-25°C)

  • ​Inactive ingredients

    glycerin, hydrated silica, treated water, PEG-8, PEG-32, sodium lauryl sulphate, tetrasodium pyrophosphate, flavor, trisodium phosphate, titanium dioxide, cocamidopropyl betaine, sodium saccharin, xanthan gum, polyacrylic acid, benzyl alcohol

  • SPL UNCLASSIFIED SECTION

    ​Since 1903

    TOOTHPASTE WITH FLUORIDE

    • For sensitive teeth and cavity protection
    • Great for everyday use

    ​Brushing twice a day with Rexall​™​ Restore & Defend Sensitive Toothpaste helps repair sensitive teeth and protect against painful sensitivity.

    • Provides daily relief & protection for sensitive teeth*
    • Contains fluoride for cavity protection
    • Removes stains for whiter teeth
    • Freshens breath

    ​100% Satisfaction Guaranteed!
    (888) 309-9030

    *With brushing twice daily

    DISTRIBUTED BY OLD EAST MAIN CO.
    100 MISSION RIDGE
    GOODLETTSVILLE, TN 37072

    PRODUCT OF INDIA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    REXALL RESTORE AND DEFEND SENSITIVE WHITENING 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-820
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.54 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE (UNII: B70850QPHR)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-820-011 in 1 BOX03/21/2022
    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 finalpart35503/21/2022
    Labeler - Old East Main CO. (068331990)
    Registrant - Ashtel Studios Inc. (148689180)