NDC Code(s) : 58118-9931-1
Packager : Clinical Solutions Wholesale

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neomycin and Polymyxin B Sulfates and HydrocortisoneNeomycin sulfate, Polymyxin B Sulfate and Hydrocortisone SUSPENSION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-9931(NDC:24208-635)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCORTISONE(UNII: WI4X0X7BPJ)
(HYDROCORTISONE - UNII:WI4X0X7BPJ) 		HYDROCORTISONE10 mg in 1 mL
NEOMYCIN SULFATE(UNII: 057Y626693)
(NEOMYCIN - UNII:I16QD7X297) 		NEOMYCIN3.5 mg in 1 mL
POLYMYXIN B SULFATE(UNII: 19371312D4)
(POLYMYXIN B - UNII:J2VZ07J96K) 		POLYMYXIN B10000 [USP'U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL(UNII: 936JST6JCN)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
SULFURIC ACID(UNII: O40UQP6WCF)
THIMEROSAL(UNII: 2225PI3MOV)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58118-9931-11 in 1 CARTON
110 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
ANDA ANDA064065 08/28/1996

PRINCIPAL DISPLAY PANEL

NeoPolyHC

Neomycin and

Polymyxin B Sulfates

and Hydrocortisone

Otic Suspension USP
(Sterile)

[icon- ear]

USE IN EARS ONLY

10 mL

Rx only