NDC Code(s) : 50804-777-01
Packager : Good Sense

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Ear Drops Carbamide Peroxide 6.5% LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50804-777
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 Peroxide6.5 g in 100 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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50804-777-011 in 1 CARTON 09/01/2017
115 mL in 1 BOTTLE 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 09/01/2017

PRINCIPAL DISPLAY PANEL

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