Label: DR. WHITISS (8.3%)- carbamide peroxide gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL

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 November 27, 2017

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  • ACTIVE INGREDIENT

    carbamide peroxide


  • INACTIVE INGREDIENT

    polyvinyl pyrrolidone (k=90), glycerin, anhydrous ethyl alcohol, distilled water, potassium dihydrogen phosphate, sodium hydroxide, lemon oil, orange oil, xylitol, l-menthol, potassium nitrate, propolis ext


  • PURPOSE

    whitening of discolored vital teeth


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    apply 2 or 3 times per day for 2 weeks for a brighter, whiter smile



  • WARNINGS

    1) do not use on patient with sensitive to carbamide peroxide
    2) do not use on patient with oral infection
    3) no to be used by pregnant or lactating women or children under 18 years old
    4) to be used under the supervision of a dentist
    5) do not swallow this medication


  • DOSAGE & ADMINISTRATION

    for dental use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    DR. WHITISS (8.3%) 
    carbamide peroxide gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-9001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.083 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47649-9001-34 in 1 PACKAGE07/11/2014
    1NDC:47649-9001-22 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:47649-9001-15 g in 1 PACKAGE; Type 0: Not a Combination Product07/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35607/11/2014
    Labeler - Nibec Co., Ltd (687796909)
    Registrant - Nibec Co., Ltd (687796909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nibec Co., Ltd687796909manufacture(47649-9001)
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