DR. WHITISS (8.3%)- carbamide peroxide gel, dentifrice 
Nibec Co., Ltd

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.

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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


package label
DR. WHITISS (8.3%) 
carbamide peroxide gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47649-9001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE0.083 g  in 1 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:47649-9001-34 in 1 PACKAGE07/11/2014
1NDC:47649-9001-22 g in 1 CYLINDER; Type 0: Not a Combination Product
2NDC:47649-9001-15 g in 1 PACKAGE; Type 0: Not a Combination Product07/11/2014
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/FEIBusiness Operations
Nibec Co., Ltd687796909manufacture(47649-9001)

Revised: 11/2017
Document Id: 5f0112bb-31bf-d5c1-e053-2a91aa0a44d5
Set id: 1f4d7ad3-433c-40b3-842e-73a327214d86
Version: 3
Effective Time: 20171127
 
Nibec Co., Ltd