Lidocaine (Page 3 of 3)

HOW SUPPLIED

Lidocaine Ointment USP, 5% is available in 35.44 g (11 /4 oz) laminate tubes with a child-resistant cap, NDC 70752-113-03.

Also, it is available as follows:

50 g double wall jar — NDC 70752-113-04

150 g double wall jar — NDC 70752-113-07

250 g double wall jar — NDC 70752-113-13

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

Manufactured by:
Quagen Pharmaceuticals LLC
West Caldwell, NJ 07006

52009

Rev. 04/21

Principal Display Panel – 35.44 g Tube Label
Lidocaine Ointment USP, 5%
Rx onlyNet Wt 35.44 g (1¼ oz)

Lidocaine Ointment USP, 5% -- 35.44g Tube
(click image for full-size original)

Principal Display Panel – 35.44 g Carton Label
Lidocaine Ointment USP, 5%
Rx onlyNet Wt 35.44 g (1¼ oz)

Lidocaine Ointment USP, 5% -- 35.44g Carton
(click image for full-size original)

Principal Display Panel – 50 g Jar Label
Lidocaine Ointment USP, 5%
Rx onlyNet Wt 50 g (1¾ oz)

Lidocaine Ointment USP, 5% -- 50g Label
(click image for full-size original)

Principal Display Panel – 150 g Jar Label
Lidocaine Ointment USP, 5%
Rx onlyNet Wt 150 g

Lidocaine Ointment USP, 5% -- 150g Label
(click image for full-size original)

Principal Display Panel – 250 g Jar Label
Lidocaine Ointment USP, 5%
Rx onlyNet Wt 250 g

Lidocaine Ointment USP, 5% -- 250g Label
(click image for full-size original)
LIDOCAINE lidocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70752-113
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
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70752-113-03 1 TUBE in 1 CARTON contains a TUBE
1 35.44 g in 1 TUBE This package is contained within the CARTON (70752-113-03)
2 NDC:70752-113-04 50 g in 1 JAR None
3 NDC:70752-113-07 150 g in 1 JAR None
4 NDC:70752-113-13 250 g in 1 JAR None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212695 04/20/2021
Labeler — QUAGEN PHARMACEUTICALS LLC (073645339)
Registrant — QUAGEN PHARMACEUTICALS LLC (073645339)
Establishment
Name Address ID/FEI Operations
QUAGEN PHARMACEUTICALS LLC 080281331 MANUFACTURE (70752-113), PACK (70752-113)

Revised: 05/2021 QUAGEN PHARMACEUTICALS LLC

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