NDC Code(s) : 0548-3012-00, 0548-3013-00, 0548-3015-00, 0548-3011-00
Packager : Amphastar Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine HydrochlorideLidocaine Hydrochloride JELLY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-3012
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987)
Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-3012-0025 in 1 BOX
15 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086283 08/07/1979
Lidocaine HydrochlorideLidocaine Hydrochloride JELLY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-3013
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987)
Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-3013-0025 in 1 BOX
110 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086283 08/07/1979
Lidocaine HydrochlorideLidocaine Hydrochloride JELLY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-3015
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987)
Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-3015-0025 in 1 BOX
120 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086283 08/07/1979
Lidocaine HydrochlorideLidocaine Hydrochloride JELLY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0548-3011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride(UNII: V13007Z41A)
(Lidocaine - UNII:98PI200987)
Lidocaine Hydrochloride20 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0548-3011-0025 in 1 BOX
15 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA086283 08/07/1979

PRINCIPAL DISPLAY PANEL

Rx ONLY
NDC 0548-3012-00
STOCK NO. 3012-SP

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
100 mg (20 mg/mL)

5 mL
STERILE PAK
URO-JET®

FOR TOPICAL USE ONLY / LOCAL ANESTHETIC / USUAL DOSAGE: SEE INSERT
SINGLE USE / NO PRESERVATIVE ADDED / STORE AT CONTROLLED ROOM TEMPERATURE 15° TO 30°C (59° TO 86°F).

EACH mL CONTAINS 20 mg OF LIDOCAINE HYDROCHLORIDE AND SODIUM CARBOXYMETHYLCELLULOSE.
SODIUM HYDROXIDE MAY HAVE BEEN ADDED TO ADJUST pH (pH 6-7).

NOTE: CONTENTS STERILE IN ORIGINAL, INTACT PACKAGE. DO NOT OPEN PACKAGE UNTIL READY TO USE.
SYRINGE ASSEMBLY DIRECTIONS: USE ASEPTIC TECHNIQUE. DO NOT ASSEMBLE UNTIL READY TO USE.

  • 1) OPEN STERILE POUCH AND DROP CONTENTS DIRECTLY ONTO STERILE FIELD. REMOVE PROTECTIVE CAPS.
  • 2) THREAD VIAL INTO INJECTOR 3 HALF TURNS, OR UNTIL NEEDLE PENETRATES STOPPER. DO NOT PUSH VIAL INTO
    INJECTOR; THIS MAY CAUSE MISALIGNMENT.

INTERNATIONAL MEDICATION SYSTEMS, LIMITED SO. EL MONTE, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company
8730120G 10-03

LOT:
EXP.:

PRINCIPAL DISPLAY PANEL - 5 mL Label

PRINCIPAL DISPLAY PANEL

Rx ONLY
NDC 0548-3013-00
STOCK NO. 3013-SP

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
200 mg (20 mg/mL)

10 mL
STERILE PAK
URO-JET®

FOR TOPICAL USE ONLY / LOCAL ANESTHETIC / USUAL DOSAGE: SEE INSERT / SINGLE USE / NO PRESERVATIVE ADDED
STORE AT CONTROLLED ROOM TEMPERATURE 15° TO 30°C (59° TO 86°F).

EACH mL CONTAINS 20 mg OF LIDOCAINE HYDROCHLORIDE AND SODIUM CARBOXYMETHYLCELLULOSE.
SODIUM HYDROXIDE MAY HAVE BEEN ADDED TO ADJUST pH TO MEET USP LIMITS OF 6 TO 7.

NOTE: CONTENTS STERILE IN ORIGINAL, INTACT PACKAGE. DO NOT OPEN PACKAGE UNTIL READY TO USE.
SYRINGE ASSEMBLY DIRECTIONS: USE ASEPTIC TECHNIQUE. DO NOT ASSEMBLE UNTIL READY TO USE.

  • 1) OPEN STERILE POUCH AND DROP CONTENTS DIRECTLY ONTO STERILE FIELD. REMOVE PROTECTIVE CAPS.
  • 2) THREAD VIAL INTO INJECTOR 3 HALF TURNS, OR UNTIL NEEDLE PENETRATES STOPPER. DO NOT PUSH VIAL INTO
    INJECTOR; THIS MAY CAUSE MISALIGNMENT.

INTERNATIONAL MEDICATION SYSTEMS, LIMITED SO. EL MONTE, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company
8730130G 10-03

LOT:
EXP.:

PRINCIPAL DISPLAY PANEL - 10 mL Label

PRINCIPAL DISPLAY PANEL

Rx ONLY
NDC 0548-3015-00
STOCK NO. 3015-SP

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
400 mg (20 mg/mL)

20 mL
STERILE PAK
URO-JET®

FOR TOPICAL USE ONLY / LOCAL ANESTHETIC / USUAL DOSAGE: SEE INSERT / SINGLE USE / NO PRESERVATIVE ADDED
STORE AT CONTROLLED ROOM TEMPERATURE 15° TO 30°C (59° TO 86°F).

EACH mL CONTAINS 20 mg OF LIDOCAINE HYDROCHLORIDE AND SODIUM CARBOXYMETHYLCELLULOSE.
SODIUM HYDROXIDE MAY HAVE BEEN ADDED TO ADJUST pH TO MEET USP LIMITS OF 6 TO 7.

NOTE: CONTENTS STERILE IN ORIGINAL, INTACT PACKAGE. DO NOT OPEN PACKAGE UNTIL READY TO USE.
SYRINGE ASSEMBLY DIRECTIONS: USE ASEPTIC TECHNIQUE. DO NOT ASSEMBLE UNTIL READY TO USE.

  • 1) OPEN STERILE POUCH AND DROP CONTENTS DIRECTLY ONTO STERILE FIELD. REMOVE PROTECTIVE CAPS.
  • 2) THREAD VIAL INTO INJECTOR 3 HALF TURNS, OR UNTIL NEEDLE PENETRATES STOPPER. DO NOT PUSH VIAL INTO
    INJECTOR; THIS MAY CAUSE MISALIGNMENT
    .

INTERNATIONAL MEDICATION SYSTEMS, LIMITED SO. EL MONTE, CA 91733, U.S.A.
An Amphastar Pharmaceuticals Company
8730150G 10-03

LOT:
EXP.:

PRINCIPAL DISPLAY PANEL - 20 mL Label

PRINCIPAL DISPLAY PANEL

NDC 0548-3011-00
STOCK NO. 3011-SP

LIDOCAINE HYDROCHLORIDE JELLY USP, 2%
100 mg (20 mg/mL)

REDUCED SIZE TIP

5 mL
STERILE PAK?URO-JET®
AC
?(ANATOMICALLY
CONSTRICTED)

FOR TOPICAL USE ONLY / LOCAL ANESTHETIC
USUAL DOSAGE: SEE INSERT / SINGLE USE / NO PRESERVATIVE ADDED?STORE AT CONTROLLED ROOM
TEMPERATURE 15° TO 30°C (59° TO 86°F).

EACH mL CONTAINS 20 mg OF LIDOCAINE HYDROCHLORIDE AND SODIUM CARBOXYMETHYLCELLULOSE
AS A VISCOSITY-INCREASING AGENT. SODIUM HYDROXIDE MAY HAVE BEEN ADDED TO ADJUST pH TO MEET
USP LIMITS OF 6 TO 7.

NOTE: CONTENTS STERILE IN ORIGINAL, INTACT PACKAGE. DO NOT OPEN PACKAGE UNTIL READY TO USE.

Rx ONLY

INTERNATIONAL MEDICATION SYSTEMS, LIMITED SO. EL MONTE, CA 91733 USA 8730110B  4-98

LOT:
EXP.:

PRINCIPAL DISPLAY PANEL - 20 mL Label