Label: DR.WHITISS 35%- carbamide peroxide gel, dentifrice

  • NDC Code(s): 47649-1301-1, 47649-1301-2
  • Packager: Nibec Co., Ltd
  • 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 26, 2018

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

  • ACTIVE INGREDIENT

    carbamide peroxide


  • INACTIVE INGREDIENT

    pyrrolidone (k=90), hydroxyethyl cellulose, glycerin, purified water, monobasic potassium phosphate, sodiu hydroxide, l-menthol, potassium nitrate, anhydrous ethanol

  • PURPOSE

    whitening of discolored teeth


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE


    1. Gingival and general oral heath should be confirmed before treatment.
    2. Brush your teeth before treatment.
    3. Follow your dentist’s instructions on how to load gel into your custom whitening tray. Use no more than 1/3 to 1/2 of the syringe per tray.
    4. Insert whitening tray in the mouth over the teeth. Seat the tray firmly agains the teeth. Remove excess gel with clean finger or soft toothbrush.(Rinse twice; do not swallow rinsed gel.)
    5. Unless directed otherwise by your dentist, wear Dr.Whitiss 10% for 8-10 hours or overnight, Dr.Whitiss 15% for 4-6 hours, Dr.Whitiss20% for 2-4 hours, and Dr.Whitiss 35% for 30 minutes.
    6. If significant sensitivity occurs, stop treatment and consult dentist.


  • 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 35% 
    carbamide peroxide gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-1301
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE35 g  in 100 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:47649-1301-24 in 1 PACKAGE08/11/2015
    1NDC:47649-1301-11 g in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/11/2015
    Labeler - Nibec Co., Ltd (687796909)
    Registrant - Nibec Co., Ltd (687796909)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nibec Co., Ltd687796909manufacture(47649-1301)