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 Injection
(VIAFLEX Container)

Health Care Provider Letter

Dear DHCP Letter_image 01
Dear DHCP Letter_image 02
Dear DHCP Letter_image 03
Dear DHCP Letter_image 04

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Representative Container Label 500 mL

BATCH
EXP
0.9% SODIUM CHLORIDE
500 mL

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 Logo
BAXTER HOSPITALAR LTDA
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CONJ 1201 E 1204 SÃO PAULO SP BRAZIL
CNPJ 49351786000180 BRAZILIAN INDUSTRY
LICENSE NUMBER 1068300690198
TECHNICAL RESPONSIBLE: LUIZ GUSTAVO TANCSIK CRF 67982
CUSTOMER SERVICE 08000125522
BAXTER AND VIAFLEX ARE BRANDS OF BAXTER INTERNATIONAL INC
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FZB1323
28 25 01 506

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
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-9517-5050 in 1 CARTON01/31/2018
1250 mL in 1 BAG; Type 0: Not a Combination Product
2NDC:0338-9517-3030 in 1 CARTON01/31/2018
2500 mL in 1 BAG; Type 0: Not a Combination Product
3NDC:0338-9517-1616 in 1 CARTON01/31/2018
31000 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 shortage01/31/2018
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: 1/2018
Document Id: 8a3c23ed-b319-4891-b5b0-29efcad61157
Set id: 8a91c5f5-c52c-4750-82b5-6bd716485a54
Version: 2
Effective Time: 20180131
 
Baxter Healthcare Corporation