Label: FAMILY WELLNESS SENSITIVE EXTRA WHITENING- potassium nitrate and 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 April 11, 2013

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  • Active Ingredients

    Potassium nitrate 5%........................................... Antihypersensitivity

    Sodium Fluoride 0.243% (0.15% w/v fluoride ion).... Anticavity toothpaste

  • USES

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


  • Purpose

    • Builds increasing protection against painful sensitivity of teeh due 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

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

  • Directions

    Adults and children 12 years and older Brush teeth for at least one minute, preferably after each meal, or at least twice a day or as directed by your dentist. Be sure to brush sensitive areas of the teeth.
    Children under 12 years of age Consult a dentist or doctor
    Other information Store in a cool, dry place.

  • Inactive ingredients

    sorbitol, water, silica, sodium lauryl sulfate, flavor, cellulose gum, titanium dioxide, sodium benzoate, sodium phosphate, tetrasodium pyrophosphate, sodium saccharin.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS SENSITIVE EXTRA WHITENING 
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-900
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Colorwhite (Sensitive) Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-900-01113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35604/11/2013
    Labeler - Family Wellness (024472631)
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