NDC Code(s) : 25431-424-02
Packager : PULSION Medical Systems SE
Category : HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule : none
Marketing Status : New Drug Application
INGREDIENTS AND APPEARANCE
| Indocyanine GreenIndocyanine Green and Water KIT | |||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
|
|||||||||||||||
PRINCIPAL DISPLAY PANEL
NDC 25431-424-01
Indocyanine Green for
Injection USP
25 mg/Vial
For Intravenous Administration
After reconstitution, use within 6 hours.
Rx only Sterile
Distributed by: PULSION Medical Inc.
Lot. No.:
Exp.:
Rev. 02/2008
PRINCIPAL DISPLAY PANEL
NDC 63323-185-10 918510
STERILE WATER
FOR INJECTION, USP
FOR DRUG DILUENT USE ONLY
Rx only
10 mL Single Dose Vial
Sterile, Nonpyrogenic
Preservative Free
Discard unused
portion.
Do not administer
intravenously
unless rendered
nearly isotonic.
Store at 20° to 25°C
(68° to 77°F) [see USP
Controlled Room
Temperature].
APP
APP Pharmaceuticals, LLC
Schaumburg, IL 60173
401753E
LOT/EXP
63323-185-10
PRINCIPAL DISPLAY PANEL
NDC 25431-424-02
Indocyanine Green
for Injection USP
25 mg/Vial
Kit
For Intravenous Administration
PULSION
Medical Systems
PULSION Medical Inc.
NDC 25431-424-02
Indocyanine Green
for Injection USP
DIRECTIONS FOR USE ENCLOSED
CAUTION: To ensure accurate readings,
Indocyanine Green dissolved in Sterile Water for
Injection must be used within 6 hours.
STORAGE: Store at 20° to 25°C (68° to 77°F)
[See USP Controlled Room Temperature].
USAGE: See package insert for dosage information.
25 mg/Vial
Kit
PULSION
Medical Systems
PULSION Medical Inc.
NDC 25431-424-02
Indocyanine Green
for Injection USP
Distributed by
PULSION Medical Inc.
3781 Attucks Drive
Powell, Ohio 43066
Manufactured by
Patheon Italia S.p.A.
Viale G.B. Stucchi, 110
20900 Monza (MB) ITALY
Sterile Water Manufactured by
APP Pharmaceutical LLC
Schaumburg IL 60173
Rx only Rev.04 01/2014
25 mg/Vial
Kit
PULSION
Medical Systems
PULSION Medical Inc.
