Label: REXALL SENSITIVE EXTRA WHITENING- potassium nitrate, sodium 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 March 23, 2022

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  • Drug Facts

  • Active ingredients

    Potassium Nitrate (5%)
    Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

  • Purpose

    Antihypersensitivity
    Anticavity

  • 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

    • Adults 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 two minutes, preferably after each meal or at least twice a day (morning and evening) 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

    Store at room temperature 68-77°F (20-25°C)

  • Inactive ingredients

    Sorbitol, Hydrated Silica, Treated water, PEG-32, Sodium Lauryl Sulfate, Glycerin, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Benzyl Alcohol, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide

  • SPL UNCLASSIFIED SECTION

    MAXIMUM STRENGTH

    TOOTHPASTE WITH FLUORIDE

    • For sensitive teeth and cavity protection

    Brushing twice a day builds a protective coating against painful sensitivity.

    • Contains potassium nitrate, clinically proven to reduce painful sensitivity
    • Fluoride for cavity protection
    • Great taste keeps mouth feeling fresh & clear

    Since 1903 Rexall™ is a trademark of Rexall Sundown, Inc.

    100% satisfaction Guaranteed!
    (888) 309-9030

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

    MADE IN INDIA

  • Packaging

    Old East-817

  • INGREDIENTS AND APPEARANCE
    REXALL SENSITIVE EXTRA WHITENING 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-817
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-817-011 in 1 BOX03/21/2022
    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 not finalpart35603/21/2022
    Labeler - Old East Main CO. (068331990)
    Registrant - Ashtel Studios Inc. (148689180)
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