FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]

FAMILY WELLNESS SENSITIVE EXTRA WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [FAMILY WELLNESS]
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NDC 55319-900-01
Set ID 22b5d423-b43a-4be9-be98-998640ff1c13
Category HUMAN OTC DRUG LABEL
Packager Family Wellness
Generic Name
Product Class
Product Number
Application Number PART356
  • 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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