Label: DR. WHITISS (8.3%)- carbamide peroxide gel, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 47649-9001-1, 47649-9001-2, 47649-9001-3 - Packager: Nibec Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated November 27, 2017
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- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- PURPOSE
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- INDICATIONS & USAGE
- WARNINGS
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INGREDIENTS AND APPEARANCE
DR. WHITISS (8.3%)
carbamide peroxide gel, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47649-9001 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE 0.083 g in 1 g Inactive Ingredients Ingredient Name Strength POVIDONE K90 (UNII: RDH86HJV5Z) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POTASSIUM NITRATE (UNII: RU45X2JN0Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47649-9001-3 4 in 1 PACKAGE 07/11/2014 1 NDC:47649-9001-2 2 g in 1 CYLINDER; Type 0: Not a Combination Product 2 NDC:47649-9001-1 5 g in 1 PACKAGE; Type 0: Not a Combination Product 07/11/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 07/11/2014 Labeler - Nibec Co., Ltd (687796909) Registrant - Nibec Co., Ltd (687796909) Establishment Name Address ID/FEI Business Operations Nibec Co., Ltd 687796909 manufacture(47649-9001)