These highlights do not include all the information needed to use GLYDO (lidocaine HCl jelly) 2% safely and effectively. See full prescribing information for GLYDO (lidocaine HCl jelly) 2%. GLYDO (lidocaine hydrochloride) 2% jelly Initial U.S. Approval: 1953

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

GLYDO (lidocaine HCl jelly) 2% is an amide local anesthetic indicated: for prevention and control of pain in procedures involving the male and female urethra for topical treatment of painful urethritis as an anesthetic lubricant for oral and nasal endotracheal intubation

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

GLYDO (lidocaine HCl jelly, USP) 2% in: 120 mg per 6 mL Prefilled Syringe 220 mg per 11 mL Prefilled Syringe

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse reactions associated with the use of GLYDO 2% Jelly were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse experiences following the administration of lidocaine are similar in nature to those observed with other amide local anesthetic agents. A major cause of adverse reactions to this group of drugs is excessive plasma levels, which may be due to overdosage or slow metabolic degradation. The most commonly encountered acute adverse reactions that demand immediate counter measures were related to the CNS and the cardiovascular system. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy, or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported. There have been rare reports of endotracheal tube occlusion associated with the presence of dried jelly residue in the inner lumen of the tube.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

Acute emergencies from local anesthetics are generally related to high plasma levels encountered during therapeutic use of local anesthetics [see Warnings and Precautions ( 5 ) and Adverse Reactions ( 6 )] . The use of this product concomitantly with other lidocaine products should be done with caution and appropriate patient monitoring.

11 DESCRIPTION

DESCRIPTION SECTION

GLYDO (lidocaine HCl jelly, USP) 2% is a sterile aqueous product that contains a local anesthetic agent and is administered topically (see INDICATIONS AND USAGE for specific uses). GLYDO (lidocaine HCl jelly, USP) 2% contains lidocaine HCl which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-, monohydrochloride, the molecular weight is 270.8. The molecular formula is C 14 H 23 ClN 2 O, and has the following structural formula: GLYDO (lidocaine HCl jelly, USP) 2% also contains hypromellose, and the resulting mixture maximizes contact with mucosa and provides lubrication for instrumentation. The unused portion should be discarded after initial use. Composition of GLYDO (lidocaine HCl jelly, USP) 2% 6 mL or 11 mL syringes: Each mL contains 20 mg of lidocaine HCl. The formulation also contains hypromellose, and sodium hydroxide to adjust pH to 6.0 to 7.0.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

GLYDO ® (lidocaine HCl jelly, USP) 2% is supplied as follows: NDC GLYDO ® (lidocaine HCl jelly, USP) 2% Package Factor (20 mg per mL) 25021-673-76 120 mg per 6 mL Single-Dose Prefilled Syringe 10 syringes per carton 25021-673-77 220 mg per 11 mL Single-Dose Prefilled Syringe 10 syringes per carton

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

SPL PATIENT PACKAGE INSERT SECTION

SPL PATIENT PACKAGE INSERT SECTION

INSTRUCTIONS FOR USE Please note: The blister package contains a sterile syringe. Do not open the blister until ready to use. When ready to use, open the blister and drop the syringe onto a sterile field. Before removing the tip cap, press in the plunger to remove any resistance that may be present. This helps ensure that the syringe will empty easily and uniformly. Remove the tip cap from the syringe. The syringe is now ready for use. GLYDO (lidocaine HCl jelly, USP) 2% should be instilled slowly and evenly into the urethra. See the DOSAGE AND ADMINISTRATION section for additional details. Wait for a few minutes after instillation of GLYDO (lidocaine HCl jelly, USP) 2% for the anesthetic to take full effect. Full anesthetic effect will occur in 5 to 10 minutes after complete instillation. Any gel not used in a single application must be discarded. sagent ® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60173 (USA) Mfd. by Klosterfrau Berlin GmbH Made in Germany ©2025 Sagent Pharmaceuticals Revised: May 2025 This “Instructions for Use” has been approved by the U.S. Food and Drug Administration.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label NDC 25021-673-76 6 mL Single-Dose Prefilled Syringe Rx only glydo ® (lidocaine HCl jelly, USP) 2% 120 mg per 6 mL (20 mg per mL) 6 mL Sterile TOPICAL Anesthetic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – Syringe Label NDC 25021-673-77 11 mL Single-Dose Prefilled Syringe Rx only glydo ® (lidocaine HCl jelly, USP) 2% 220 mg per 11 mL (20 mg per mL) 11 mL Sterile TOPICAL Anesthetic