LIDOCAINE HYDROCHLORIDE (Page 3 of 3)

MAXIMUM RECOMMENDED DOSAGES

Normal Healthy Adults

The maximum recommended dose of Lidocaine Hydrochloride Topical Solution, USP 4% should be such that the dose of lidocaine hydrochloride is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) body weight.

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 of less than ten years who have a normal lean body mass and normal body development, the maximum dose may be determined by the application of one of the standard pediatric drug formulas (e.g., Clark’s rule). For example, in a child of five years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75 to 100 mg when calculated according to Clark’s rule. In any case, the maximum dose of Lidocaine Hydrochloride with epinephrine should not exceed 7 mg/kg (3.2 mg/lb) of body weight. When used without epinephrine, the amount of Lidocaine Hydrochloride administered should be such that the dose of lidocaine is kept below 300 mg and in any case should not exceed 4.5 mg/kg (2 mg/lb) of body weight.

HOW SUPPLIED

Lidocaine Hydrochloride Topical Solution, USP 4% is supplied in 50 mL bottle (NDC 60432-465-50) and packaged in a carton (NDC 60432-465-51). An aqueous solution for topical application. NOT FOR INJECTION.

RECOMMENDED STORAGE

Store at 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature].

AVOID FREEZING

Rx Only

Product No.: 8465

Manufactured By:

Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

Manufactured For:

Wockhardt USA, LLC

Parsippany, NJ 07054

28465

REV. 06-20

PRINCIPAL DISPLAY PANEL

MGP

NDC 60432-465-51

LIDOCAINE

HYDROCHLORIDE

TOPICAL

SOLUTION, USP

4%

NOT FOR INJECTION

TOPICAL USE ONLY

Rx Only

NET: 1 ⅔ fl oz (50 mL)

carton-r1222

LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-465 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 40 mg in 1 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL METHYLPARABEN WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:60432-465-51 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS (60432-465-50) 1 NDC:60432-465-50 50 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (60432-465-51)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA087881 11/18/1982

Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)

Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)

Establishment
Name	Address	ID/FEI	Operations
Morton Grove Pharmaceuticals, Inc.		801897505	ANALYSIS (60432-465), MANUFACTURE (60432-465), PACK (60432-465)

Establishment
Name	Address	ID/FEI	Operations
Societa Italiana Medicinali Scandicci S.I.M.S. SrL — Italy		428994180	API MANUFACTURE (60432-465)

Revised: 03/2022 Morton Grove Pharmaceuticals, Inc.