Label: IODENT SENSITIVE- potassium nitrate,sodium fluoride 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 February 15, 2022

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  • Active Ingredient

    Potassium Nitrate 5%

    Sodium Fluoride . 0.15%

  • Purpose

    Antihypersensitivity

    Anticavity

  • Use

    Builds increasing protection against painful sensitivity of the teeth due to cold , heat , acids, sweets or contact.

    Aids in the prevention of dental cavities

  • Warning

    Stop use and ask a dentist if

    The problem persists or worsens. Sensitive teeth may indicate a serious problem that may prompt care by a dentist

    Pain/sensitivity still persists after 4 weeks of use

  • Directions

    Adults and children 12 years of age and older

    Apply at least at 1-inch strip of product onto a soft bristle toothbrush

    Brush teeth thoroughly for at least 1 minute twice a day( morning and evening), and not more than 3 times a 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

  • Inactive Ingredients

    calcium carbonate , water, sorbitol , silica, polyethylene glycol 400, sodium laury alcohol, sodium carboxymethyl cellulose, flavor, sodium saccharin, methylparaben, propyparaben , sodium hydroxide

  • Keep out of reach of children under 6 years of age

    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

  • PRINCIPAL DISPLAY PANEL

    21

  • INGREDIENTS AND APPEARANCE
    IODENT SENSITIVE 
    potassium nitrate,sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72129-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM SILICATE (UNII: IJF18F77L3)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
    POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
    SORBITOL (UNII: 506T60A25R)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72129-002-0124 in 1 BOX02/02/2018
    112 in 1 PACKAGE
    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 finalpart35602/02/2018
    Labeler - Zhaoqing Longda Biotechnology Co., Ltd. (546452557)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhaoqing Longda Biotechnology Co., Ltd.546452557manufacture(72129-002)
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