Vaccine Information: IPOL (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 10 Dose Vial Label

multi-dose vial (10 DOSES)
IPV
Poliovirus Vaccine
Inactivated — IPOL®

Dosage: 0.5 mL IM or SC.
Rx only
See enclosed package insert.
Store at 2° to 8°C (35° to 46°F).
DO NOT FREEZE.

US Govt Lic #1724
Mfg by: Sanofi Pasteur SA,
Marcy L’Etoile France Dist by: Sanofi Pasteur Inc.

Principal Display Panel -- 10 Dose Vial Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 Dose Vial Package

NDC 49281-860-10
IPV

multi-dose vial (10 DOSES)

Poliovirus Vaccine Inactivated — IPOL®

FOR INTRAMUSCULAR OR SUBCUTANEOUS ADMINISTRATION.

Rx only

SANOFI PASTEUR

PRINCIPAL DISPLAY PANEL -- 10 Dose Vial Package
(click image for full-size original)
IPOL poliovirus type 1 antigen (formaldehyde inactivated), poliovirus type 2 antigen (formaldehyde inactivated), and poliovirus type 3 antigen (formaldehyde inactivated) injection, suspension
Product Information
Product Type VACCINE Item Code (Source) NDC:49281-860
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED) 40 [D’ag’U] in 0.5 mL
POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED) 8 [D’ag’U] in 0.5 mL
POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) (POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)) POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED) 32 [D’ag’U] in 0.5 mL
Inactive Ingredients
Ingredient Name Strength
PHENOXYETHANOL 3 uL in 0.5 mL
FORMALDEHYDE 20 ug in 0.5 mL
NEOMYCIN 5 ng in 0.5 mL
STREPTOMYCIN 200 ng in 0.5 mL
POLYMYXIN B 25 ng in 0.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49281-860-10 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE (49281-860-78)
1 NDC:49281-860-78 5 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (49281-860-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103930 12/21/1990
Labeler — Sanofi Pasteur Inc. (086723285)
Establishment
Name Address ID/FEI Operations
Sanofi Pasteur Inc. 578763542 MANUFACTURE

Revised: 06/2022 Sanofi Pasteur Inc.

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