Lidocaine (Page 3 of 3)

HOW SUPPLIED

Lidocaine Ointment USP, 5% is White to slight yellow translucent ointment and available in below packs:
50 gram (13/4 oz) laminate tubes with a child-resistant cap NDC 83008-024-50


Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
Manufactured for:
Macleods Pharma USA, Inc.
Princeton, NJ 08540

Manufacturer:
Macleods Pharmaceuticals Limited
At Oxalis Labs Baddi, Himachal Pradesh, INDIA

Revised: September 2022

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LIDOCAINE lidocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:83008-024(NDC:33342-405)
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 300
POLYETHYLENE GLYCOL 1450
Product Characteristics
Color WHITE (White to slight yellow translucent ointment) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:83008-024-50 1 TUBE in 1 CARTON contains a TUBE
1 50 g in 1 TUBE This package is contained within the CARTON (83008-024-50)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211697 05/26/2023
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 relabel (83008-024)

Revised: 03/2024 Quality Care Products, LLC

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