LIDOCAINE HYDROCHLORIDE AND DEXTROSE- lidocaine hydrochloride 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.

----------

Lidocaine Hydrochloride 0.4% and 5% Dextrose

Health Care Provider Letter

DHCP Letter 1
DHCP Letter 2
DHCP Letter 3
DHCP Letter 4
DHCP Letter 5
DHCP Letter 6
DHCP Letter 7
DHCP Letter 8
DHCP Letter 9
DHCP Letter 10
DHCP Letter 11
DHCP Letter 12
DHCP Letter 13
DHCP Letter 14
DHCP Letter 15
DHCP Letter 16
DHCP Letter 17

PACKAGE/LABEL PRINCIPAL DI SPLAY PANEL

Lidocaine Drug Shortage JB0972 Representative Container Lbl

JB0972
250 mL
DIN 00828602
Lidocaine Hydrochloride 0.4% and 5% Dextrose Injection /
Chlorhydrate de Lidocaine á 0.4% dans du Dextrose á
5%, Injectable
Lidocaine Hydrochloride and Dextrose Injection USP / Chlorhydrate
de Lidocaine dans du Dextrose USP, Injectable
Lidocaine
4 mg/mL
1 g / 250 mL
Bar Code

(01)00809080000548

EACH mL CONTAINS / CHAQUE mL CONTIENT
LIDOCAINE HYDROCHLORIDE /
CHLORHYDRATE DE LIDOCAINE 4 mg
DEXTROSE / DEXTROSE – 50 mg
SODIUM HYDROXIDE (PH ADJUSTER) /
HYDROXYDE DE SODIUM (AJUSTEUR DE PH)
WATER FOR INJECTION / EAU POUR INJECTION
APPROX mOsmol/L 282 APPROX pH 5.0
ANTIARRHYTHMIC AGENT FOR INTRAVENOUS
INFUSION ONLY / AGENT ANTIARYTHMIQUE
POUR PERFUSION INTRAVEINEUSE SEULEMENT
USUAL DOSAGE SINGLE DOSE 50 mg – 100 mg AT A RATE OF 2550 mg
PER MIN / DO NOT EXCEED 300 mg PER HOUR / CONTINUOUS
INFUSION AT A RATE OF 1 TO 2 mg PER MIN / NOT RECOMMENDED FOR
USE IN CHILDREN
WARNINGS DO NOT ADD SUPPLEMENTARY MEDICATION / MUST NOT
BE USED IN SERIES CONNECTIONS / DO NOT USE SIMULTANEOUSLY
WITH BLOOD
CAUTIONS SQUEEZE AND INSPECT BAG / DO NOT USE UNLESS
SOLUTION IS CLEAR / SINGLE USE / DISCARD UNUSED PORTION /
STORE AT 15ºC TO 25ºC / PRODUCT MONOGRAPH AVAILABLE ON
REQUEST / HEALTHCARE PROFESSIONAL DISPENSE WITH
CONSUMER INFORMATION
POSOLOGIE HABITUELLE DOSE UNIQUE DE 50 mg – 100 MG A UN
DEBIT DE 25-50 mg PAR MIN / NE PAS DEPASSER 300 mg PAR HEURE /
PERFUSION CONTINUE A UN DEBIT DE 1 A 2 mg PAR MIN / N’EST PAS
RECOMMANDE EN PEDIATRIE
MISES EN GARDE NE PAS AJOUTER DAUTRES MEDICAMENTS / NE
PAS RACCORDER EN SERIE / NE PAS UTILISER SIMULTANEMENT AVEC
DU SANG
PRECAUTIONS COMPRIMER ET EXAMINER LA POCHE / NE PAS
UTILISER SI LA SOLUTION N’EST PAS LIMPIDE / N’UTILISER QU’UNE
SEULE FOIS / JETER TOUTE PORTION INUTILISEE / CONSERVER
ENTRE 15ºC ET 25ºC / MONOGRAPHIE OFFERTE SUR DEMANDE /
PROFESSIONNEL DE LA SANTE DISTRIBUER AVEC LES
RENSEIGNEMENTS POUR LE CONSOMMATEUR
NONPYROGENIC / STERILE / APYROGENE
QUESTIONS OR CONCERNS/
QUESTIONS OU PREOCCUPATIONS
Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2 1-800-719-9955

VIAFLEX® PVC CONTAINER/
CONTENANT DE PVC

No Latex Symbol
07-25-77-873

Lidocaine Drug Shortage JB0973 Representative Container Lbl

JB0973
500 mL
DIN 00828602
Lidocaine Hydrochloride 0.4% and 5% Dextrose
Injection / Chlorhydrate de Lidocaine á 0.4%
dans du Dextrose á 5% Injectable
Lidocaine Hydrochloride and Dextrose Injection USP /
Chlorhydrate de Lidocaine dans du Dextrose USP,
Injectable
Lidocaine
4 mg/mL
2 g / 500 mL
Bar Code

(01)00809080000555

EACH mL CONTAINS / CHAQUE mL CONTIENT
LIDOCAINE HYDROCHLORIDE / CHLORHYDRATE DE LIDOCAINE 4 mg
DEXTROSE / DEXTROSE – 50 mg
SODIUM HYDROXIDE (PH ADJUSTER) / HYDROXYDE DE SODIUM
(AJUSTEUR DE PH)
WATER FOR INJECTION / EAU POUR INJECTION
APPROX mOsmol/L 282 APPROX pH 5.0
ANTIARRHYTHMIC AGENT FOR INTRAVENOUS INFUSION ONLY /
AGENT ANTIARYTHMIQUE POUR PERFUSION INTRAVEINEUSE SEULEMENT
USUAL DOSAGE SINGLE DOSE 50 mg – 100 mg AT A RATE OF 2550 mg PER
MIN / DO NOT EXCEED 300 mg PER HOUR / CONTINUOUS INFUSION AT A RATE
OF 1 TO 2 mg PER MIN / NOT RECOMMENDED FOR USE IN CHILDREN
WARNINGS DO NOT ADD SUPPLEMENTARY MEDICATION / MUST NOT BE USED
IN SERIES CONNECTIONS / DO NOT USE SIMULTANEOUSLY WITH BLOOD
CAUTIONS SQUEEZE AND INSPECT BAG / DO NOT USE UNLESS
SOLUTION IS CLEAR / SINGLE USE / DISCARD UNUSED PORTION / STORE AT
15ºC TO 25ºC / PRODUCT MONOGRAPH AVAILABLE ON REQUEST /
HEALTHCARE PROFESSIONAL DISPENSE WITH CONSUMER INFORMATION
POSOLOGIE HABITUELLE DOSE UNIQUE DE 50 mg – 100 MG A UN DEBIT DE
25-50 mg PAR MIN / NE PAS DEPASSER 300 mg PAR HEURE / PERFUSION
CONTINUE A UN DEBIT DE 1 A 2 mg PAR MIN / N’EST PAS RECOMMANDE EN
PEDIATRIE
MISES EN GARDE NE PAS AJOUTER D’AUTRES MEDICAMENTS / NE PAS
RACCORDER EN SERIE / NE PAS UTILISER SIMULTANEMENT AVEC DU SANG
PRECAUTIONS COMPRIMER ET EXAMINER LA POCHE / NE PAS UTILISER SI LA
SOLUTION N’EST PAS LIMPIDE / N’UTILISER QU’UNE SEULE FOIS / JETER TOUTE
PORTION INUTILISEE / CONSERVER ENTRE 15ºC ET 25ºC / MONOGRAPHIE
OFFERTE SUR DEMANDE / PROFESSIONNEL DE LA SANTE DISTRIBUER AVEC
LES RENSEIGNEMENTS POUR LE CONSOMMATEUR
NONPYROGENIC / STERILE / APYROGENE
QUESTIONS OR CONCERNS/
QUESTIONS OU PREOCCUPATIONS
Baxter Logo
Baxter Corporation
Mississauga ON L5N 0C2 1-800-719-9955

VIAFLEX® PVC CONTAINER/
CONTENANT DE PVC

No Latex Symbol
07-25-77-872

LIDOCAINE HYDROCHLORIDE AND DEXTROSE 
lidocaine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9590
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 50 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-9590-30 30 in 1 CARTON 10/13/2017 03/31/2019
1 250 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 10/13/2017 03/31/2019
LIDOCAINE HYDROCHLORIDE AND DEXTROSE 
lidocaine hydrochloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-9586
Route of Administration INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) 50 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0338-9586-24 24 in 1 CARTON 10/13/2017 03/31/2019
1 500 mL in 1 BAG; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug for use in drug shortage 10/13/2017 03/31/2019
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Business Operations
Baxter Corporation 205087968 ANALYSIS(0338-9590, 0338-9586) , LABEL(0338-9590, 0338-9586) , MANUFACTURE(0338-9590, 0338-9586) , PACK(0338-9590, 0338-9586) , STERILIZE(0338-9590, 0338-9586)

Revised: 3/2019
Baxter Healthcare Corporation