Label: SENSITIVE TEETH- potassium nitrate paste

  • 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 August 10, 2017

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  • ACTIVE INGREDIENT

    Active ingredients

    Postassium nitrate, 5%

  • PURPOSE

    Purpose

    Antisensitivity

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • INDICATIONS & USAGE

    Use builds increasing protection against painful sensitivity of the teeth to cold, acids, sweets, or contact

  • WARNINGS

    Warnings

    When using this product, if pain/sensitivity still persists after 4 weeks or use, please visit your dentist

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 12 years of age and older
    • Apply at least a 1-inch strip of the product onto soft bristle toothbrush
    • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist
    • Make sure to brush all sensitive areas of the teeth
    • Children under 12 years of age: consult a dentist or doctor
  • INACTIVE INGREDIENT

    Inactive ingredients

    Calcium carbonate, Sorbitol, Agua, Glycerin, Hydrate Silica, Xynthol, Coco-glucoside, Xanthan Gum, Mentha Viridis (Spearmint) Leaf Oil, Menthol, Leuconostoc/Radish Root Ferment Filtrate

  • PRINCIPAL DISPLAY PANEL

    image

  • INGREDIENTS AND APPEARANCE
    SENSITIVE TEETH 
    potassium nitrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76098-001
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    SORBITOL (UNII: 506T60A25R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MENTHA SPICATA (UNII: O2H83I4PUN)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76098-001-0175 mL in 1 BOX; Type 0: Not a Combination Product07/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/06/2017
    Labeler - The Green Beaver Company Ltd. (243807018)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermolab Pharma Ltee245414743manufacture(76098-001)
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