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Dr.Whitiss 35%

Medically reviewed on August 13, 2018

Dosage form: gel, dentifrice
Ingredients: CARBAMIDE PEROXIDE 35g in 100g
Labeler: Nibec Co., Ltd
NDC Code: 47649-1301

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


DR.WHITISS 35%  
carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-1301
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE35 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POVIDONE K90 
glycerin 
water 
POTASSIUM NITRATE 
Packaging
#Item CodePackage Description
1NDC:47649-1301-11 g in 1 SYRINGE
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/FEIOperations
Nibec Co., Ltd687796909manufacture(47649-1301)

 
Nibec Co., Ltd

Further information

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

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