SODIUM CHLORIDE- sodium chloride injection 
Baxter Healthcare Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0.9% Sodium Chloride

Health Care Provider Letter

DHCP Letter - Image 01
DHCP Letter - Image 02
DHCP Letter - Image 03
DHCP Letter - Image 04
DHCP Letter - Image 05

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Sodium Chloride Drug Shortage Representative Sample Label

BATCH
EXP
0.9% Sodium Chloride
100mL
VIAFLEX
CLOSURE SYSTEM
STORE AT ROOM TEMPERATURE (15°C TO 30°C)
ADULT AND PEDIATRIC USE EACH 100ML CONTAINS
SODIUM CHLORIDE 900MG WATER FOR INJECTION SUFFICIENT
QUANTITY TO 100ML SODIUM 154 MEQ/L CHLORIDE 154 MEQ/L
pH APPROX 5.0 OSMOLARITY APPROX 308 mOsml/L
INTRAVENOUS ADMINISTRATION STERILE NONPYROGENIC
SOLUTION DO NOT USE IF TURBIDITY IS PRESENT SINGLE USE
DISCARD AFTER USE INFORMATION TO THE HEALTHCARE
PROFESSIONAL INDICATIONS CONTRAINDICATIONS AND
PRECAUTIONS REFER TO PACKAGE INSERT ALL MEDICINES
SHOULD BE KEPT OUT OF THE REACH OF CHILDREN
REMOVE THE OVERPOUCH FOR USE LATEX FREE PRODUCT
RESTRICTED USE FOR HOSPITALS SALE UNDER MEDICAL
PRESCRIPTION
BAXTER
BAXTER HOSPITALAR LTDA
HENRI DUNANT STREET 1383 12º FLOOR TOWER B
CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300690171
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
PRINTED IN BRAZIL
25
50
75
28 25 01 500
FZB1307

SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0338-9517
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE900 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9517-7272 in 1 CARTON01/15/201808/01/2019
1100 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug for use in drug shortage01/15/201808/01/2019
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Hospitalar Ltda.900203175ANALYSIS(0338-9517) , MANUFACTURE(0338-9517) , LABEL(0338-9517) , PACK(0338-9517) , STERILIZE(0338-9517)

Revised: 8/2019
Document Id: 2c996521-145d-4606-a55f-eb1597bc3b63
Set id: 7dba97cf-7c58-4b98-8aee-d80b0cb56d41
Version: 5
Effective Time: 20190801
 
Baxter Healthcare Corporation