Xylocaine (lidocaine HCl) Injections Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14 H 22 N 2O • HCl) has the following structural formula: Xylocaine Structural Formula Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt.183.21. Epinephrine (C 9 H 13 NO 3 ) has the following structural formula: Epinephrine Structural Formula Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are M ethyl P araben F ree ( MPF ). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Structural Formula for Xylocaine Structural Formula for Epinephrine

Xylocaine (lidocaine HCl) Injections

Mfr: OTC
FunFoxMeds bottle

Drug Facts

Composition & Profile

Active Ingredients
ACTIVE INGREDIENT Povidone-iodine USP ACTIVE INGREDIENT Isopropyl Alcohol 70 % v/v
Inactive Ingredients
INACTIVE INGREDIENTS citric acid disodium phosphate nonoxynol-9 sodium hydroxide water INACTIVE INGREDIENT Water
Strengths
57 unit 0.5 % 250 mg/50 ml 5 mg/ml 50 ml 27 unit 1 % 200 mg/20 ml 10 mg/ml 20 ml 500 mg/50 ml 17 unit 2 % 200 mg/10 ml 20 mg/ml 10 ml 400 mg/20 ml 1000 mg/50 ml 20 mg/2 ml 2 ml 50 mg/5 ml 5 ml 97 unit 100 mg/10 ml 37 unit 300 mg/30 ml 30 ml 31 unit 1.5 % 150 mg/10 ml 15 mg/ml 91 unit 300 mg/20 ml 40 mg/2 ml 07 unit 100 mg/5 ml 450 mg/30 ml 21 unit 70 %
Quantities
50 ml 20 ml 10 ml 2 ml 5 ml 30 ml 1 dose 7898 kit
Treats Conditions
Indications And Usage Xylocaine Lidocaine Hcl Injections Are Indicated For Production Of Local Or Regional Anesthesia By Infiltration Techniques Such As Percutaneous Injection And Intravenous Regional Anesthesia By Peripheral Nerve Block Techniques Such As Brachial Plexus And Intercostal And By Central Neural Techniques Such As Lumbar And Caudal Epidural Blocks When The Accepted Procedures For These Techniques As Described In Standard Textbooks Are Observed Use Antiseptic Skin Preparation Use For Preparation Of The Skin Prior To Injection

Identifiers & Packaging

Container Type BOTTLE
SPL Set IDs
5dba6f5e-19c9-4a30-a5c5-74e6dc906704
Packaging

HOW SUPPLIED Xylocaine ® (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 480457 NDC 63323-484-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-484-57 50 mL Multiple Dose Vial 480527 NDC 63323-485-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-485-01 20 mL Multiple Dose Vial 480557 NDC 63323-485-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-485-03 50 mL Multiple Dose Vial 480617 NDC 63323-486-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-486-01 10 mL Multiple Dose Vial 480627 NDC 63323-486-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-486-02 20 mL Multiple Dose Vial 480657 NDC 63323-486-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-486-05 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 491157 NDC 63323-491-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-491-01 50 mL Single Dose Vial 491227 NDC 63323-492-27 Unit of 25 1% (20 mg per 2 mL) (10 mg per mL) NDC 63323-492-04 2 mL Single Dose Vial 491257 NDC 63323-492-57 Unit of 25 1% (50 mg per 5 mL) (10 mg per mL) NDC 63323-492-09 5 mL Single Dose Vial 491297 NDC 63323-492-97 Unit of 5 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-492-08 10 mL Plastic Ampule 491237 NDC 63323-492-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-07 30 mL Single Dose Vial 491231 NDC 63323-492-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-03 30 mL Single Dose Vial 491397 NDC 63323-493-97 Unit of 5 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-493-03 10 mL Plastic Ampule 491391 NDC 63323-493-91 Unit of 5 1.5% (300 mg per 20 mL) (15 mg per mL) NDC 63323-493-01 20 mL Plastic Ampule 491527 NDC 63323-495-27 Unit of 25 2% (40 mg per 2 mL) (20 mg per mL) NDC 63323-495-09 2 mL Single Dose Vial 491507 NDC 63323-495-07 Unit of 25 2% (100 mg per 5 mL) (20 mg per mL) NDC 63323-495-04 5 mL Single Dose Vial 491697 NDC 63323-496-97 Unit of 5 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-496-03 10 mL Plastic Ampule Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Product Code Unit of Sale Strength Each 480217 NDC 63323-482-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-482-01 10 mL Multiple Dose Vial 480227 NDC 63323-482-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-482-03 20 mL Multiple Dose Vial 480257 NDC 63323-482-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-482-05 50 mL Multiple Dose Vial 480327 NDC 63323-483-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-483-03 20 mL Multiple Dose Vial 480357 NDC 63323-483-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-483-01 50 mL Multiple Dose Vial Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480157 NDC 63323-481-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-481-01 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480717 NDC 63323-487-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-487-01 10 mL Single Dose Vial 480737 NDC 63323-487-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-07 30 mL Single Dose Vial 480731 NDC 63323-487-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-03 30 mL Single Dose Vial 480817 NDC 63323-488-17 Unit of 25 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-488-01 10 mL Single Dose Vial 480837 NDC 63323-488-37 Unit of 25 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-07 30 mL Single Dose Vial 480831 NDC 63323-488-31 Unit of 5 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-03 30 mL Single Dose Vial 480917 NDC 63323-489-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-489-01 10 mL Single Dose Vial 480927 NDC 63323-489-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-02 20 mL Single Dose Vial 480921 NDC 63323-489-21 Unit of 5 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-03 20 mL Single Dose Vial For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Fresenius Kabi Logo; PRINCIPAL DISPLAY PANEL: D-Care 100X NDC 49836-016-23 RX-Only D-Care 100X Kit Contains: 1 XYLOCAINE † - MPF 1% with Epinephrine Single Dose Vial (10 mg/mL) (10 mL) 1 DERMABLADE † 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 2 Sterile Packs of Cotton Tip 6" Applicator (4 Applicators) 3 Sterile VASELINE † White Petroleum Jelly 5 gm Peel Packet 1 Dose Needles and Syringes Not Included 1 ONE NEEDLE, ONE SYRINGE, ONLY ONE TIME. Safe Injection Practices Coalition www.ONEandONLYcampaign.org Members of One & Only Campaign D-Care 100X DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-016-23 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: XYLOCAINE † - MPF 1% with Epinephrine 1 :200,000 (10 mg/mL)* (APP Fresenius Kabi USA, LLC) Lidocaine HCl and Epinephrine Injection, USP DERMABLADE † * (AccuTec Blades, Inc) Sterile APLICARE † Povidone-Iodine Swabsticks* (Clorox Professional Products Company) Sterile Nitrile Powder-Free Gloves* (Dynarex) - Size 7.5 Sterile Towel Drape* (Dynarex) Sterile Fenestrated Towel Drape* (Dynarex) Sterile Adhesive Bandage* (Dynarex) Sterile Adhesive Spot Bandage* (Dynarex) Sterile 4x4 Gauze* (Dynarex) Sterile Alcohol Prep Pad 70% by Volume* (Dynarex) Sterile Cotton Tipped Applicator* (Dynarex) Sterile VASELINE † White Petroleum Jelly Packet* (Covidien) † All trademarks and registered trademarks noted herein are the property of their respective owners. * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING : KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE For Single use Only. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement. D-Care 100X D-Care 100X

Package Descriptions
  • HOW SUPPLIED Xylocaine ® (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 480457 NDC 63323-484-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-484-57 50 mL Multiple Dose Vial 480527 NDC 63323-485-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-485-01 20 mL Multiple Dose Vial 480557 NDC 63323-485-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-485-03 50 mL Multiple Dose Vial 480617 NDC 63323-486-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-486-01 10 mL Multiple Dose Vial 480627 NDC 63323-486-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-486-02 20 mL Multiple Dose Vial 480657 NDC 63323-486-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-486-05 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl Injection, USP) Product Code Unit of Sale Strength Each 491157 NDC 63323-491-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-491-01 50 mL Single Dose Vial 491227 NDC 63323-492-27 Unit of 25 1% (20 mg per 2 mL) (10 mg per mL) NDC 63323-492-04 2 mL Single Dose Vial 491257 NDC 63323-492-57 Unit of 25 1% (50 mg per 5 mL) (10 mg per mL) NDC 63323-492-09 5 mL Single Dose Vial 491297 NDC 63323-492-97 Unit of 5 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-492-08 10 mL Plastic Ampule 491237 NDC 63323-492-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-07 30 mL Single Dose Vial 491231 NDC 63323-492-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-492-03 30 mL Single Dose Vial 491397 NDC 63323-493-97 Unit of 5 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-493-03 10 mL Plastic Ampule 491391 NDC 63323-493-91 Unit of 5 1.5% (300 mg per 20 mL) (15 mg per mL) NDC 63323-493-01 20 mL Plastic Ampule 491527 NDC 63323-495-27 Unit of 25 2% (40 mg per 2 mL) (20 mg per mL) NDC 63323-495-09 2 mL Single Dose Vial 491507 NDC 63323-495-07 Unit of 25 2% (100 mg per 5 mL) (20 mg per mL) NDC 63323-495-04 5 mL Single Dose Vial 491697 NDC 63323-496-97 Unit of 5 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-496-03 10 mL Plastic Ampule Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:100,000 Product Code Unit of Sale Strength Each 480217 NDC 63323-482-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-482-01 10 mL Multiple Dose Vial 480227 NDC 63323-482-27 Unit of 25 1% (200 mg per 20 mL) (10 mg per mL) NDC 63323-482-03 20 mL Multiple Dose Vial 480257 NDC 63323-482-57 Unit of 25 1% (500 mg per 50 mL) (10 mg per mL) NDC 63323-482-05 50 mL Multiple Dose Vial 480327 NDC 63323-483-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-483-03 20 mL Multiple Dose Vial 480357 NDC 63323-483-57 Unit of 25 2% (1,000 mg per 50 mL) (20 mg per mL) NDC 63323-483-01 50 mL Multiple Dose Vial Xylocaine ® (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480157 NDC 63323-481-57 Unit of 25 0.5% (250 mg per 50 mL) (5 mg per mL) NDC 63323-481-01 50 mL Multiple Dose Vial Xylocaine ® -MPF (lidocaine HCl and epinephrine Injection, USP) with Epinephrine 1:200,000 Product Code Unit of Sale Strength Each 480717 NDC 63323-487-17 Unit of 25 1% (100 mg per 10 mL) (10 mg per mL) NDC 63323-487-01 10 mL Single Dose Vial 480737 NDC 63323-487-37 Unit of 25 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-07 30 mL Single Dose Vial 480731 NDC 63323-487-31 Unit of 5 1% (300 mg per 30 mL) (10 mg per mL) NDC 63323-487-03 30 mL Single Dose Vial 480817 NDC 63323-488-17 Unit of 25 1.5% (150 mg per 10 mL) (15 mg per mL) NDC 63323-488-01 10 mL Single Dose Vial 480837 NDC 63323-488-37 Unit of 25 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-07 30 mL Single Dose Vial 480831 NDC 63323-488-31 Unit of 5 1.5% (450 mg per 30 mL) (15 mg per mL) NDC 63323-488-03 30 mL Single Dose Vial 480917 NDC 63323-489-17 Unit of 25 2% (200 mg per 10 mL) (20 mg per mL) NDC 63323-489-01 10 mL Single Dose Vial 480927 NDC 63323-489-27 Unit of 25 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-02 20 mL Single Dose Vial 480921 NDC 63323-489-21 Unit of 5 2% (400 mg per 20 mL) (20 mg per mL) NDC 63323-489-03 20 mL Single Dose Vial For single-dose vials and ampules: Discard unused portion. All solutions should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of Fresenius Kabi USA, LLC. Fresenius Kabi Logo www.fresenius-kabi.com/us 4 5 1 1 7 5 F Revised: March 2019 Fresenius Kabi Logo
  • PRINCIPAL DISPLAY PANEL: D-Care 100X NDC 49836-016-23 RX-Only D-Care 100X Kit Contains: 1 XYLOCAINE † - MPF 1% with Epinephrine Single Dose Vial (10 mg/mL) (10 mL) 1 DERMABLADE † 1 Sterile Povidone-Iodine Swabsticks (3 Swabs) 1 Sterile Pair Nitrile Powder-Free Gloves (Size 7.5) 1 Sterile Towel Drape 1 Sterile Fenestrated Towel Drape 2 Sterile Adhesive Bandage 2 Sterile Adhesive Spot Bandage 3 Sterile Packs of 4x4 Gauze (6 Gauzes) 5 Sterile Isopropyl Alcohol 70% Prep Pad 2 Sterile Packs of Cotton Tip 6" Applicator (4 Applicators) 3 Sterile VASELINE † White Petroleum Jelly 5 gm Peel Packet 1 Dose Needles and Syringes Not Included 1 ONE NEEDLE, ONE SYRINGE, ONLY ONE TIME. Safe Injection Practices Coalition www.ONEandONLYcampaign.org Members of One & Only Campaign D-Care 100X DISTRIBUTED BY: SCHMIGS HAUPPAUGE, NY 11788 NDC 49836-016-23 MANUFACTURED BY: Rx Pharma Pack HAUPPAUGE, NY 11788 Questions/Comments 1-844-632-7898 Kit Contents: XYLOCAINE † - MPF 1% with Epinephrine 1 :200,000 (10 mg/mL)* (APP Fresenius Kabi USA, LLC) Lidocaine HCl and Epinephrine Injection, USP DERMABLADE † * (AccuTec Blades, Inc) Sterile APLICARE † Povidone-Iodine Swabsticks* (Clorox Professional Products Company) Sterile Nitrile Powder-Free Gloves* (Dynarex) - Size 7.5 Sterile Towel Drape* (Dynarex) Sterile Fenestrated Towel Drape* (Dynarex) Sterile Adhesive Bandage* (Dynarex) Sterile Adhesive Spot Bandage* (Dynarex) Sterile 4x4 Gauze* (Dynarex) Sterile Alcohol Prep Pad 70% by Volume* (Dynarex) Sterile Cotton Tipped Applicator* (Dynarex) Sterile VASELINE † White Petroleum Jelly Packet* (Covidien) † All trademarks and registered trademarks noted herein are the property of their respective owners. * Internal package components remain sterile when stated as long as items are unopened and undamaged. WARNING : KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. PROTECT FROM LIGHT/AVOID FREEZING STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F) [SEE USP CONTROLLED ROOM TEMPERATURE] DO NOT REFRIGERATE For Single use Only. Directions for Use: See enclosed inserts. SUSTAINABLE Certified Sourcing FORESTRY www.sfiprogram.org INITIATIVE SFI-01376 ORG 04/2017 This product is not eligible for Medicare or Medicaid reimbursement. D-Care 100X D-Care 100X
Overview

Xylocaine (lidocaine HCl) Injections are sterile, nonpyrogenic, aqueous solutions that contain a local anesthetic agent with or without epinephrine and are administered parenterally by injection. See INDICATIONS AND USAGE section for specific uses. Xylocaine solutions contain lidocaine HCl, which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride and has the molecular wt. 270.8. Lidocaine HCl (C 14 H 22 N 2O • HCl) has the following structural formula: Xylocaine Structural Formula Epinephrine is (-) -3, 4-Dihydroxy-α-[(methylamino) methyl] benzyl alcohol and has the molecular wt.183.21. Epinephrine (C 9 H 13 NO 3 ) has the following structural formula: Epinephrine Structural Formula Dosage forms listed as Xylocaine-MPF indicate single dose solutions that are M ethyl P araben F ree ( MPF ). Xylocaine MPF is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Xylocaine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 6.5 (5.0 to 7.0) with sodium hydroxide and/or hydrochloric acid. Xylocaine MPF with Epinephrine is a sterile, nonpyrogenic, isotonic solution containing sodium chloride. Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer. Xylocaine with Epinephrine in multiple dose vials: Each mL also contains 1 mg methylparaben as antiseptic preservative. The pH of these solutions is adjusted to approximately 4.5 (3.3 to 5.5) with sodium hydroxide and/or hydrochloric acid. Filled under nitrogen. Structural Formula for Xylocaine Structural Formula for Epinephrine

Indications & Usage

Xylocaine (lidocaine HCl) Injections are indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed. USE Antiseptic skin preparation USE For preparation of the skin prior to injection.

Dosage & Administration

Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Xylocaine Injection for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required, only solutions containing epinephrine should be used except in those cases where vasopressor drugs may be contraindicated. There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Xylocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION ). These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for the elderly and debilitated patients and patients with cardiac and/or liver disease. The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Xylocaine Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Xylocaine Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine HCl is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected. For intravenous regional anesthesia, only the 50 mL single dose vial containing Xylocaine (lidocaine HCl) 0.5% Injection should be used. Epidural Anesthesia For epidural anesthesia, only the following dosage forms Xylocaine Injection are recommended: 1% without epinephrine 10 mL Plastic Ampule 1% without epinephrine 30 mL single dose solutions 1% with epinephrine 1:200,000 30 mL single dose solutions 1.5% without epinephrine 10 mL Plastic Ampule 1.5% without epinephrine 20 mL Plastic Ampule 1.5% with epinephrine 1:200,000 30 mL ampules, 30 mL single dose solutions 2% without epinephrine 10 mL Plastic Ampule 2% with epinephrine 1:200,000 20 mL ampules, 20 mL single dose solutions Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block, provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the numb r of dermatomes to be anesthetized (generally 2 to 3 mL of the indicated concentration per dermatome). Caudal and Lumbar Epidural Block As a precaution against the adverse experience sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2 to 3 mL of 1.5% lidocaine HCl should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter.Epinephrine, if contained in the test dose (10 to 15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Xylocaine Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered. In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter. Maximum Recommended Dosages Adults For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight, and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia. The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly, five minutes between sides (see also discussion of paracervical block in PRECAUTIONS ). For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults. Children It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs the dose of lidocaine HCl should not exceed 75 to 100 mg (1.5 to 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 to 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children. In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. The Injection is not to be used if its color is pinkish or darker than slightly yellow or if it contains a precipitate. Table 1: Recommended Dosages Procedure Xylocaine (lidocaine hydrochloride) Injection (without epinephrine) Conc (%) Vol (mL) Total Dose (mg) Infiltration Percutaneous 0.5 or 1 1 to 60 5 to 300 Intravenous regional 0.5 10 to 60 50 to 300 Peripheral Nerve Blocks, e.g., Brachial 1.5 15 to 20 225 to 300 Dental 2 1 to 5 20 to 100 Intercostal 1 3 30 Paravertebral 1 3 to 5 30 to 50 Pudendal (each side) 1 10 100 Paracervical Obstetrical analgesia (each side) 1 10 100 Sympathetic Nerve Blocks, e.g., Cervical (stellate ganglion) 1 5 50 Lumbar 1 5 to 10 50 to 100 Central Neural Blocks Epidural * Thoracic 1 20 to 30 200 to 300 Lumbar Analgesia 1 25 to 30 250 to 300 Anesthesia 1.5 15 to 20 225 to 300 2 10 to 15 200 to 300 Caudal Obstetrical analgesia 1 20 to 30 200 to 300 Surgical anesthesia 1.5 15 to 20 225 to 300 *Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome). THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE.OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED. DIRECTIONS Apply locally as needed DIRECTIONS Wipe injection site vigorously and discard.

Warnings & Precautions
WARNINGS XYLOCAINE INJECTIONS FOR INFILTRATION AND NERVE BLOCK SHOULD BE EMPLOYED ONLY BY CLINICIANS WHO ARE WELL VERSED IN DIAGNOSIS AND MANAGEMENT OF DOSE-RELATED TOXICITY AND OTHER ACUTE EMERGENCIES THAT MIGHT ARISE FROM THE BLOCK TO BE EMPLOYED AND THEN ONLY AFTER ENSURING THE IMMEDIATE AVAILABILITY OF OXYGEN, OTHER RESUSCITATIVE DRUGS, CARDIOPULMONARY EQUIPMENT AND THE PERSONNEL NEEDED FOR PROPER MANAGEMENT OF TOXIC REACTIONS AND RELATED EMERGENCIES (see also ADVERSE REACTIONS and PRECAUTIONS ). DELAY IN PROPER MANAGEMENT OF DOSE-RELATED TOXICITY, UNDERVENTILATION FROM ANY CAUSE AND/OR ALTERED SENSITIVITY MAY LEAD TO THE DEVELOPMENT OF ACIDOSIS, CARDIAC ARREST AND, POSSIBLY, DEATH. Methemoglobinemia Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended. Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue Xylocaine and any other oxidizing agents. Depending on the severity of the signs and symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. A more severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen. Intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures is an unapproved use, and there have been post-marketing reports of chondrolysis in patients receiving such infusions. The majority of reported cases of chondrolysis have involved the shoulder joint; cases of gleno-humeral chondrolysis have been described in pediatric and adult patients following intra-articular infusions of local anesthetics with and without epinephrine for periods of 48 to 72 hours. There is insufficient information to determine whether shorter infusion periods are not associated with these findings. The time of onset of symptoms, such as joint pain, stiffness and loss of motion can be variable, but may begin as early as the 2nd month after surgery. Currently, there is no effective treatment for chondrolysis; patients who experienced chondrolysis have required additional diagnostic and therapeutic procedures and some required arthroplasty or shoulder replacement. To avoid intravascular injection, aspiration should be performed before the local anesthetic solution is injected. The needle must be repositioned until no return of blood can be elicited by aspiration. Note, however, that he absence of blood in the syringe does not guarantee that intravascular injection has been avoided. Local anesthetic solutions containing antimicrobial preservatives (e.g., methylparaben) should not be used for epidural or spinal anesthesia because the safety of these agents has not been established with regard to intrathecal injection, either intentional or accidental. Xylocaine with epinephrine solutions contain sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Anaphylactic reactions may occur following administration of lidocaine hydrochloride (see ADVERSE REACTIONS ). In the case of severe reaction, discontinue the use of the drug. WARNINGS Do not use if allergic to iodine in the eyes For external use only Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Ask a doctor before use if injuries are deep or puncture wounds serious burns Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases infection occurs Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. WARNINGS For external use only Flammable, keep away from flame or fire Not for use with electrocautinary devices or procedures Do not use in eyes Sterile unless package is damaged or open Stop use and ask a doctor if: Irritation or redness develops Condition persists for more than 72 hours Cleansing of an injection site Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.
Contraindications

Lidocaine HCl is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type.

Purpose

PURPOSE Antiseptic PURPOSE Antiseptic

Storage & Handling

OTHER INFORMATION 1% titratable iodine Not made with natural rubber latex For hospital or professional use only Applicator is STERILE if package is intact. Manufactured by: Aplicare Products, LLC, 550 Research Parkway Meriden, CT 06450 USA Made in USA For questions or comments 800-633-5463 Revised: 12/2019 OTHER INFORMATION Store at room temperature: 15 deg C to 30 deg C 59 deg F to 86 deg F Avoid excessive heat Reorder No. 1113 Made in China Manufactured for: Dynarex Corporation Orangeburg, NY 10962 www.dynarex.com Revised: 11/2019

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