MEDICAL PROVIDER SINGLE USE EZ FLU SHOT 2018-2019- influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/singapore/gp2050/2015 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/utah/9/2014 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/hong kong/259/2010 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), isopropyl alcohol 
Asclemed USA, Inc.

----------

Principal Display Panel - Kit Carton Label

NDC 76420-521-01 RX-Only

Medical Provider

Single Use EZ Flu Shot™

2018·2019 Formula

Kit Contains:

1 Flucelvax ®* Pre-Filled Syringe (0.5 mL)

1 Isopropyl Alcohol 70% Prep Pad

1 Spot Adhesive Bandage

1 Pair Nitrile Powder Free Sterile Gloves (M)

1 Drape

Needle Not Included

1 Dose

Distributed by Enovachem

PHARMACEUTICALS

Torrance, CA 90501

Principal Display Panel - Kit Carton Label
MEDICAL PROVIDER SINGLE USE EZ FLU SHOT 2018-2019 
influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/singapore/gp2050/2015 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/utah/9/2014 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/hong kong/259/2010 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), isopropyl alcohol kit
Product Information
Product TypeVACCINEItem Code (Source)NDC:76420-521
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76420-521-011 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 SYRINGE, GLASS 0.5 mL
Part 21 POUCH 5 mL
Part 1 of 2
FLUCELVAX QUADRIVALENT (PREFILLED SYRINGE) 
influenza a virus a/singapore/gp1908/2015 ivr-180 (h1n1) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza a virus a/singapore/gp2050/2015 (h3n2) hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/utah/9/2014 hemagglutinin antigen (mdck cell derived, propiolactone inactivated), influenza b virus b/hong kong/259/2010 hemagglutinin antigen (mdck cell derived, propiolactone inactivated) injection, suspension
Product Information
Route of AdministrationINTRAMUSCULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: QWJHW3WEXS) (INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:55QH9PJKDV) INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: HRT2X6KFJO) (INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:41Q3TYMWV2) INFLUENZA A VIRUS A/SINGAPORE/GP2050/2015 (H3N2) ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: MQM6XOH1SZ) (INFLUENZA B VIRUS B/UTAH/9/2014 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:9VVQ21KI5Z) INFLUENZA B VIRUS B/UTAH/9/2014 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) (UNII: XZF56ICU1B) (INFLUENZA B VIRUS B/HONG KONG/259/2010 HEMAGGLUTININ ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED) - UNII:56OC384IDL) INFLUENZA B VIRUS B/HONG KONG/259/2010 ANTIGEN (MDCK CELL DERIVED, PROPIOLACTONE INACTIVATED)15 ug  in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
110 in 1 CARTON
10.5 mL in 1 SYRINGE, GLASS; Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12540805/23/201605/31/2019
Part 2 of 2
ISOPROPYL ALCOHOL 
isopropyl alcohol swab
Product Information
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISOPROPYL ALCOHOL (UNII: ND2M416302) 70 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-820-095 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/200705/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
BLABLA12540805/23/201605/31/2019
Labeler - Asclemed USA, Inc. (059888437)

Revised: 1/2022
Document Id: d50b8dd2-3c36-01e0-e053-2a95a90a44cd
Set id: 337a837d-c87d-46f3-a019-12ca7d0a9bcb
Version: 3
Effective Time: 20220107
 
Asclemed USA, Inc.