NDC Code(s) : 60846-701-35, 60846-701-50
Packager : Gemini Laboratories, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

LidocaineLidocaine OINTMENT
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60846-701
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE50 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
1NDC:60846-701-3535.44 g in 1 TUBE Type 0: Not a Combination Product03/11/2016
2NDC:60846-701-5050 g in 1 JAR Type 0: Not a Combination Product03/11/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206297 03/11/2016 11/30/2018

PRINCIPAL DISPLAY PANEL

label 1

label 1

label 1