Label: SENSITIVE WHITENING TOOTH-PASTE- 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 January 11, 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 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-1500, sodium lauryl sulfate, flavor, glycerin, cellulose gum, tetrasodium pyrophosphate, titanium dioxide, sodium benzoate, trisodium phosphate, sodium saccharin, sodium hydroxide, methylparaben, propylparaben

  • SPL UNCLASSIFIED SECTION

    Compare to Sensodyne®

    Extra Whitening active ingredients*

    Maximum Strength with Fluoride

    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 • 909-434-0911

    OUR QUALITY GUARANTEE

    WWW.MEIJER.COM/SATISFACTION

    MADE IN INDIA

    PAPER BOX

    PLASTIC TUBE

    how2recycle.info

    *This product is not manufactured or distributed by Block Drug Company, Inc. owner of the registered trademark Sensodyne®.

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    SENSITIVE WHITENING TOOTH-PASTE 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79481-0008
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.43 mg  in 1 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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79481-0008-11 in 1 BOX12/24/2020
    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 finalpart35612/24/2020
    Labeler - Meijer, Inc. (006959555)
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