CIPRODEX (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 71205-309-75
Rx Only
CIPRODEX®
(ciprofloxacin 0.3% and dexamethasone 0.1%)
STERILE OTIC SUSPENSION
7.5 mL
Alcon®
a Novartis company

71205-309-75
(click image for full-size original)
CIPRODEX ciprofloxacin and dexamethasone suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-309(NDC:0065-8533)
Route of Administration AURICULAR (OTIC) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ciprofloxacin Hydrochloride (Ciprofloxacin) Ciprofloxacin 3 mg in 1 mL
Dexamethasone (Dexamethasone) Dexamethasone 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride
Boric Acid
Sodium Chloride
Hydroxyethyl Cellulose (1500 Mpa.s At 1%)
Tyloxapol
Acetic Acid
Sodium Acetate
Edetate Disodium
Water
Sodium Hydroxide
Hydrochloric Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-309-75 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 7.5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (71205-309-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021537 08/04/2003
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (71205-309), RELABEL (71205-309)

Revised: 03/2020 Proficient Rx LP

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