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Dr. Whitiss (8.3%)

Medically reviewed on November 27, 2017

Dosage form: gel, dentifrice
Ingredients: CARBAMIDE PEROXIDE 0.083g in 1g
Labeler: Nibec Co., Ltd
NDC Code: 47649-9001

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


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


whitening of discolored vital teeth


keep out of reach of the children


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



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 (8.3%) 
carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-9001
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE0.083 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POVIDONE K90 
GLYCERIN 
WATER 
POTASSIUM NITRATE 
Packaging
#Item CodePackage Description
1NDC:47649-9001-34 CYLINDER in 1 PACKAGE
1NDC:47649-9001-22 g in 1 CYLINDER
2NDC:47649-9001-15 g in 1 PACKAGE
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/FEIOperations
Nibec Co., Ltd687796909manufacture(47649-9001)

 
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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