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Dr.Whitiss 10%

Dosage form: gel, dentifrice
Ingredients: CARBAMIDE PEROXIDE 10g in 100g
Labeler: Nibec Co., Ltd
NDC Code: 47649-0101

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 Facts

carbamide peroxide

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

whitening of discolored teeth

keep out of reach of the children

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.

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

for dental use only

carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-0101
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:47649-0101-24 SYRINGE in 1 PACKAGE
1NDC:47649-0101-11 g in 1 SYRINGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/07/2015
Labeler - Nibec Co., Ltd (687796909)
Registrant - Nibec Co., Ltd (687796909)
Nibec Co., Ltd687796909manufacture(47649-0101)

Nibec Co., Ltd

Medically reviewed on Dec 26, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.