Lixtraxen 1% (Page 4 of 4)

HOW SUPPLIED

Lidocaine Hydrochloride and Epinephrine Injection, USP is supplied in multiple-dose containers as shown below:

NDC No.

Container

Size

Qty ( in nos)

Drug Concentration

Lidocaine HCl

Epinephrine

Multiple-dose

70529-100-01

Fliptop Vial

20 mL

1

1%

1:100,000

70529-100-03

Fliptop Vial

20 mL

2

1%

1:100,000

70529-100-05

Fliptop Vial

20 mL

3

1%

1:100,000

70529-100-11

Fliptop Vial

30 mL

1

1%

1:100,000

70529-100-13

Fliptop Vial

30 mL

2

1%

1:100,000

70529-100-15

Fliptop Vial

30 mL

3

1%

1:100,000

Storage: Store in a cool dry place at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

LAB-1298-1.0

Revised: 04/2018

Lixtraxen 1% Injection System

Contents (NDC 70529-100-01):

1 — 20mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Contents (NDC 70529-100-03):

2 — 20mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Contents (NDC 70529-100-05):

3 — 20mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Contents (NDC 70529-100-11):

1 — 30mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Contents (NDC 70529-100-13):

2 — 30mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Contents (NDC 70529-100-15):

3 — 30mL 1% Lidocaine w/ EPI (10mg/mL — 1:100,000)

1 — 3cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 10cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 25 Gauge 1-1 1/2 in Needle (Administer)

1 — 22 Gauge 3 in Spinal Needle (Administer)

1 — 22 Gauge 6 in Spinal Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

Assembled and Distributed by IT3 Medical, LLC
190 E Stacy Road; STE 306-298 Allen, TX 75002-8734
For questions or comments: info@IT3-Medical.com, www.IT3-Medical.com

Packaging

Litraxn
(click image for full-size original)

LIXTRAXEN 1%
lidocaine hydrochloride and epinephrine injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70529-100
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
EPINEPHRINE (EPINEPHRINE) EPINEPHRINE 10 ug in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
SODIUM METABISULFITE 0.5 mg in 1 mL
ANHYDROUS CITRIC ACID 0.2 mg in 1 mL
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70529-100-01 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
1 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-01)
2 NDC:70529-100-03 2 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
2 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-03)
3 NDC:70529-100-05 3 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
3 20 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-05)
4 NDC:70529-100-11 1 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
4 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-11)
5 NDC:70529-100-13 2 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
5 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-13)
6 NDC:70529-100-15 3 VIAL, MULTI-DOSE in 1 PACKAGE contains a VIAL, MULTI-DOSE
6 30 mL in 1 VIAL, MULTI-DOSE This package is contained within the PACKAGE (70529-100-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA089644 01/01/2019
Labeler — IT3 Medical LLC (079971231)

Revised: 01/2019 IT3 Medical LLC

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