Label: ULTIMATE WHITE SENSITIVE 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 28, 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-1500, Sodium Lauryl Sulfate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben

  • Questions or comments?

    1-877-274-8358

  • SPL UNCLASSIFIED SECTION

    TWIN PACK

    SENSITIVE TOOTHPASTE

    MAXIMUM STRENGTH WITH FLUORIDE

    FOR SENSITIVE TEETH AND CAVITY PROTECTION
    RELIEVES PAINFUL SENSITIVITY

    EXTRA WHITENING

    DESIGNED IN U.S.A.
    MANUFACTURED IN INDIA

    Brush Buddies®
    BRUSHBUDDIES.COM    ONTARIO, CA 91761

    QUESTIONS OR COMMENTS?
    1-877-274-8358 TOLL FREE IN U.S.A.
    1-909-434-0911 INTERNATIONAL

    COPYRIGHTS AND TRADEMARKS GRANTED OR PENDING WORLDWIDE
    DISTRIBUTED BY ASHTEL STUDIOS INC.

  • Packaging

    Ashtel-075

  • INGREDIENTS AND APPEARANCE
    ULTIMATE WHITE SENSITIVE WHITENING 
    potassium nitrate, sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-075
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-075-012 in 1 BOX03/24/2023
    199 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 finalpart35603/24/2023
    Labeler - Ashtel Studios, Inc. (148689180)
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