Label: MEIJER SENSITIVE EXTRA WHITENING- potassium nitrate, sodium fluoride paste, dentifrice

  • 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 September 25, 2023

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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 one minute, 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

  • Questions or comments?

    Call toll free 1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    MAXIMUM STRENGTH WITH FLUORIDE

    COMPARE TO SENSODYNE® EXTRA WHITENING ACTIVE INGREDIENTS*

    FOR SENSITIVE TEETH AND CAVITY PROTECTION
    RELIEVES PAINFUL SENSITIVITY

    Brushing twice a day helps build a protective coating against painful sensitivity.
    • Reduces painful sensitivity
    • Cavity protection formula
    • Freshens breath
    • Helps remove stains for a whiter smile

    DIST. BY MEIJER DISTRIBUTION, INC.
    GRAND RAPIDS, MI 49544
    www.meijer.com

    OUR QUALITY GUARANTEE
    www.meijer.com/satisfaction

    C. No. DNH/COS/DNH/52 • 1223049071

    MADE IN INDIA

    *This product is not manufactured or distributed by GSK Consumer Healthcare, Inc. owner of the registered trademark Sensodyne®.

  • Packaging

    Toothpaste-0038

  • INGREDIENTS AND APPEARANCE
    MEIJER SENSITIVE EXTRA WHITENING 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0038
    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) SODIUM FLUORIDE0.24 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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0038-11 in 1 BOX09/21/2023
    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 finalM02209/21/2023
    Labeler - Meijer, Inc. (006959555)
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