NDC Code(s) : 61874-002-26, 61874-002-72, 61874-002-30
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EMLAlidocaine and prilocaine CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61874-002
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
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61874-002-261 in 1 CARTON 30/12/1992
15 g in 1 TUBE Type 0: Not a Combination Product
2NDC:61874-002-725 in 1 CARTON 30/12/1992
25 g in 1 TUBE Type 0: Not a Combination Product
3NDC:61874-002-301 in 1 CARTON 30/12/1992
330 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
NDA NDA019941 12/30/1992 04/30/2018

PRINCIPAL DISPLAY PANEL

NDC 61874-002-72        5 Grams
EMLA®
CREAM (lidocaine 2.5%
and prilocaine 2.5%)
For Topical Use Only
Rx only

NDC 61874-002-72 5 Grams EMLA® CREAM (lidocaine 2.5% and prilocaine 2.5%) For Topical Use Only Rx only

PRINCIPAL DISPLAY PANEL

NDC 61874-002-30        30 Grams
EMLA®
CREAM (lidocaine 2.5%
and prilocaine 2.5%)
For Topical Use Only

NDC 61874-002-30 30 Grams EMLA® CREAM (lidocaine 2.5% and prilocaine 2.5%) For Topical Use Only