BACTERIOSTATIC WATER (Page 2 of 2)

PRINCIPAL DISPLAY PANEL — VIAL LABEL OPTION 2

PRINCIPAL DISPLAY PANEL -- VIAL LABEL OPTION 2
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PRINCIPAL DISPLAY PANEL — VIAL LABEL OPTION 3

PRINCIPAL DISPLAY PANEL -- VIAL LABEL OPTION 3
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PRINCIPAL DISPLAY PANEL — VIAL LABEL OPTION 4

PRINCIPAL DISPLAY PANEL -- VIAL LABEL OPTION 4
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PRINCIPAL DISPLAY PANEL — VIAL LABEL OPTION 5

PRINCIPAL DISPLAY PANEL -- VIAL LABEL OPTION 5
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PRINCIPAL DISPLAY PANEL — SERIALIZED VIAL LABELING

SERIALIZED VIAL LABELING
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BACTERIOSTATIC WATER
bacteriostatic water injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51662-1473(NDC:0409-3977)
Route of Administration INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WATER (WATER) WATER 1 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 9 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51662-1473-1 30 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018802 12/14/2019
Labeler — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Registrant — HF Acquisition Co LLC, DBA HealthFirst (045657305)
Establishment
Name Address ID/FEI Operations
HF Acquisition Co LLC, DBA HealthFirst 045657305 relabel (51662-1473)

Revised: 02/2020 HF Acquisition Co LLC, DBA HealthFirst

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