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Dr. Whitiss (8.3%)

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)

Revised: 11/2017
 
Nibec Co., Ltd

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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