LIDOCAINE- lidocaine ointment 
Aleor Dermaceuticals Limited

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Lidocaine Ointment USP, 5%
FOR TOPICAL USE ONLY. DO NOT USE IN THE EYES
Rx Only

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

30g tube

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)

35g tube

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)

50g jar
LIDOCAINE 
lidocaine ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71589-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71589-001-301 in 1 CARTON11/30/2018
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:71589-001-351 in 1 CARTON11/30/2018
235.44 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:71589-001-5050 g in 1 JAR; Type 0: Not a Combination Product11/30/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21146911/30/2018
Labeler - Aleor Dermaceuticals Limited (871411532)
Registrant - Aleor Dermaceuticals Limited (871411532)
Establishment
NameAddressID/FEIBusiness Operations
Encube Ethicals Pvt. Ltd.725076298MANUFACTURE(71589-001)

Revised: 7/2019
Document Id: 39d24a2b-3446-42e7-8495-5719c1afde99
Set id: 8b70f717-54b1-47ab-8d4e-ac74c43f30a3
Version: 1
Effective Time: 20190731
 
Aleor Dermaceuticals Limited