NDC Code(s) : 50090-1197-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine and PrilocaineLidocaine and Prilocaine CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-1197(NDC:50383-667)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE25 mg in 1 g
PRILOCAINE(UNII: 046O35D44R)
(PRILOCAINE - UNII:046O35D44R) 		PRILOCAINE25 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)(UNII: Z135WT9208)
Product Characteristics
Color WHITE (white to off-white) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50090-1197-01 in 1 CARTON 28/11/2014
130 g in 1 TUBE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076290 09/25/2003 06/30/2017

PRINCIPAL DISPLAY PANEL

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