LIDOCAINE by Aleor Dermaceuticals Limited / Encube Ethicals Pvt. Ltd. LIDOCAINE ointment

LIDOCAINE by

Drug Labeling and Warnings

LIDOCAINE by is a Prescription medication manufactured, distributed, or labeled by Aleor Dermaceuticals Limited, Encube Ethicals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 71589-001-30

Rx only

Lidocaine Ointment USP, 5%

Laminate Tube with Child-Resistant Cap

FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

NET WT 30 g

NDC: 71589-001-35

Rx only

Lidocaine Ointment USP, 5%

Laminate Tube with Child-Resistant Cap

FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

NET WT 35.44 g (1¼ Oz)

NDC: 71589-001-50

Rx only

Lidocaine Ointment USP, 5%

Wide mouth Jar with Child-Resistant Cap

FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES

NET WT 50 g (1¾ Oz)

INGREDIENTS AND APPEARANCE

LIDOCAINE 
lidocaine ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71589-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71589-001-30	1 in 1 CARTON	11/30/2018
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 71589-001-35	1 in 1 CARTON	11/30/2018
2		35.44 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 71589-001-50	50 g in 1 JAR; Type 0: Not a Combination Product	11/30/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA211469	11/30/2018

Labeler - Aleor Dermaceuticals Limited (871411532)

Registrant - Aleor Dermaceuticals Limited (871411532)

Establishment
Name	Address	ID/FEI	Business Operations
Encube Ethicals Pvt. Ltd.		725076298	MANUFACTURE(71589-001)