Label: BRUSH BUDDIES 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 26, 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 used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • 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 after meals or at least twice a day or use as directed by a dentist. 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.

  • Inactive ingredients

    Sorbitol, Hydrated Silica, Treated Water, PEG-1500, Sodium Lauryl Sulphate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben

  • Questions or comments?

    call toll free 1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    FRESH MINT

    • FRESHENS BREATH
    • STRENGTHENS TEETH WITH ACTIVE FLUORIDE

    Compares to the active ingredients in Sensodyne® Extra Whitening*

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

    DESIGNED IN U.S.A.  •  MADE IN INDIA

    Brush Buddies®
    WWW.BRUSHBUDDIES.COM

    QUESTIONS OR COMMENTS?
    1-877-274-8358 TOLL FREE IN USA
    1-909-434-0911 INTERNATIONAL

    PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

    DISTRIBUTED BY ASHTEL STUDIOS INC.
    ONTARIO, CALIFORNIA 91761

  • Packaging

    Brush Buddies-079

  • INGREDIENTS AND APPEARANCE
    BRUSH BUDDIES SENSITIVE EXTRA WHITENING 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-079
    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)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Fresh mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-079-011 in 1 BOX09/07/2023
    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 finalM02209/07/2023
    Labeler - Ashtel Studios, Inc. (148689180)
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