Lidocaine (Page 3 of 3)

HOW SUPPLIED

Lidocaine Ointment USP, 5% is supplied as a white to off white translucent, homogenous ointment, free of lumps and foreign matter and available in the following packs:

35.44 g laminate tubes with a child-resistant cap NDC 71205-814-44

8 35.44 g laminate tubes with a child-resistant cap; 283.52 g total NDC 71205-814-52

Store at 20º to 25ºC (68º to 77ºF); excursions permitted between 15º to 30ºC (59º to 86ºF) [See USP Controlled Room Temperature].

Manufactured by: Strides Pharma Science Limited. Bengaluru, India.

Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816

Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Revised: 11/2018

PRINCIPAL DISPLAY PANEL

Lidocaine Ointment USP, 5%

FOR TOPICAL USE

DO NOT USE IN THE EYES

Laminate Tubes with Child — Resistant Cap

71205-814-52
(click image for full-size original)

8 laminate tubes label — 35.44 g each, 283.52 g total

LIDOCAINE lidocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-814(NDC:64380-789)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL 1450
POLYETHYLENE GLYCOL 300
Product Characteristics
Color WHITE (White to off white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-814-44 35.44 g in 1 TUBE None
2 NDC:71205-814-52 8 TUBE in 1 CARTON contains a TUBE
2 35.44 g in 1 TUBE This package is contained within the CARTON (71205-814-52)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210958 01/01/2019
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (71205-814)

Revised: 06/2023 Proficient Rx LP

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.