Lido-Sorb External (Page 2 of 2)

NURSING MOTHERS

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing mother.

PEDIATRIC USE

Dosage in pediatric patients would be reduced commensurate with age, body weight and physical condition.

Adverse Reactions to Lido-Sorb External

During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or maybe the locus of abnormal sensation.

DOSAGE AND ADMINISTRATION

Apply a thin film to the affected area 1 -3 times daily or as directed by a physician.

HOW SUPPLIED

Lidocaine HCl 3% Lotion is supplied in the following size:

SIZE	NDC#
6oz. (177 mL) Bottle	70981-165-06

KEEP THIS AND ALL MEDICAT ION OUT OF THE REACH OF CHILDREN.

STORAGE

Store at 25°C (77°F); excursions permitted to 15° — 30°C (59° — 86°F). Protect from freezing [See USP Controlled Room Temperature].

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

Mfg. for & Distributed by: Chadwick Pharmaceuticals, LLC, Madison, MS 39110

For Customer Service or Adverse Reactions: 1-800-701-8485

PRINCIPAL DISPLAY PANEL — 177 mL Bottle Label

NDC 70981-165-06
Rx Only

LIDO-SORB™
Lidocaine HCL 3%
External Lotion

Smooth
Easily Spreadable

Topical Anesthetic

Net Wt. 6 oz (177 mL)

CHADWICK
Pharmaceuticals

LIDO-SORB EXTERNAL lidocaine hydrochloride lotion

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70981-165 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 30 mg in 177 mL

Inactive Ingredients Ingredient Name Strength MINERAL OIL POLYSORBATE 60 SORBITAN MONOSTEARATE CETYL ALCOHOL STEARYL ALCOHOL STEARIC ACID METHYLPARABEN PROPYLPARABEN PETROLATUM WATER GLYCERIN EDETATE DISODIUM CALCIUM ACETATE ALUMINUM SULFATE SODIUM HYDROXIDE

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:70981-165-06 177 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/02/2019

Labeler — Chadwick Pharmaceuticals, LLC (080250085)

Establishment
Name	Address	ID/FEI	Operations
BioZone Laboratories, Inc		962455320	manufacture (70981-165)

Revised: 12/2020 Chadwick Pharmaceuticals, LLC