NDC Code(s) : 0904-4062-03
Packager : Major Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oral Peroxidecarbamide peroxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0904-4062
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE(UNII: 31PZ2VAU81)
(HYDROGEN PEROXIDE - UNII:BBX060AN9V) 		CARBAMIDE PEROXIDE0.1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GLYCERIN(UNII: PDC6A3C0OX)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SODIUM LAUROYL SARCOSINATE(UNII: 632GS99618)
SODIUM STANNATE(UNII: NJ7C1V83KG)
WATER(UNII: 059QF0KO0R)
MINT(UNII: FV98Z8GITP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0904-4062-031 in 1 CARTON
160 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part356 11/25/2011

PRINCIPAL DISPLAY PANEL

NDC 0904-4062-03

Oral Peroxide

(Carbamide Peroxide 10%)

ANTISEPTIC ORAL CLEANSER

For minor mouth or gum irritations

Recommended by Doctors and Dentists

  • Cleanses dental appliance irritations
  • Soothes canker sores
  • Kills odor-forming germs

2 fl oz (60 ml)

Oral Peroxide