Label: IODENT SENSITIVE FRESH MINT- potassium nitrate and sodium floride 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 December 21, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                                        Purpose

    Potassium nitrate 5%--------------------------------------------------- Antihypersensitivity

    Sodium fluoride (0.15% w/v fluoride ion)------------------------------Anticavity

  • PURPOSE

    Uses

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

    Warnings

  • STOP USE

    Stop use and ask a dentist if

    • the problem persists or worsens. Sensitivie teeth may indicate a serious problem that may prompt care by a dentist
    • pain/sensitivity still persists after 4 weeks of use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

  • INDICATIONS & USAGE

    Directions

    adults and children 12 years of age and older

    • apply at least a 1-inch strip of product onto a soft bristle toothbruch
    • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommende 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

  • STORAGE AND HANDLING

    Other Information

    • store below 40°C (86°F)
    • Lot No & Exp Date:see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Silica, Sorbitol, Sodium Lauryl Alcohol, Polyethylene Glycol 300, Sodium Carboxymethylcellulose, Floavor, Sodium Sacchrin, Titanium Dioxide, Sodium Pyrophosphate, PEG/PPG 116/66 Copolymer, Color: Lemon Yellow & Bright Blue

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    IODENT SENSITIVE FRESH MINT 
    potassium nitrate and sodium floride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-101
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.15 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-101-131 in 1 CARTON12/21/2016
    1113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/23/2014
    Labeler - United Exchange Corp. (840130579)