Label: UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 52000-109-01
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 17, 2023

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  • ACTIVE INGREDIENT

    Active Ingredients

    Potassium Nitrate  5%

    Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

  • PURPOSE

    Purpose

    Antihypersensitivity

    Anticavity

  • INDICATIONS & USAGE

    Uses

    • builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.
    • aids in the prevention of dental cavities.
  • WARNINGS

    Warning

  • WHEN USING

    When using this product

    • if pain\ sensitivity still persists after 4 weeks of use, please visit your dentist.
  • STOP USE

    Stop and ask a dentist

    • if the problem persists or worsens.

    Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • If accidentally swallowed more than used for brushing, seek professional help or contact a Poison Control Center immediately.
  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older
    • apply at least a 1-inch strip of product onto soft bristle toothbrush
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times day, or as recommended by a dentist or doctor.
    • 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.

  • SPL UNCLASSIFIED SECTION

    Other information

    • store in a cool, dry place.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

    label

  • INGREDIENTS AND APPEARANCE
    UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-109
    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 ION0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-109-01122 g in 1 TUBE; Type 0: Not a Combination Product05/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/20/2020
    Labeler - Universal Distribution Center LLC (019180459)
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