NDC Code(s) : 0295-1224-02
Packager : Denison Pharmaceuticals, LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

DEBROXCarbamide Peroxide LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0295-1224
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMIDE PEROXIDE(UNII: 31PZ2VAU81)
(HYDROGEN PEROXIDE - UNII:BBX060AN9V) 		CARBAMIDE PEROXIDE0.065 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)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0295-1224-021 in 1 CARTON 01/01/2017
115 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part344 01/01/2017

PRINCIPAL DISPLAY PANEL

Debrox® DROPS
Carbamide Peroxide 6.5% Non USP*
Earwax Removal Aid
½ FL OZ (15mL)

PRINCIPAL DISPLAY PANEL Debrox DROPS Carbamide Peroxide 6.5% Non USP* Earwax Removal Aid ½ FL OZ (15mL)