NDC Code(s) : 66538-301-15
Packager : COSMOCEUTICAL RESEARCH CENTER INC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANESTHETIC LIDOCAINE HYDROCHLORIDE BENZOCAINE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66538-301
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE(UNII: V13007Z41A)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE HYDROCHLORIDE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
TROLAMINE(UNII: 9O3K93S3TK)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
ALLANTOIN(UNII: 344S277G0Z)
DMDM HYDANTOIN(UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
BENZOCAINE(UNII: U3RSY48JW5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:66538-301-1515 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 02/18/2012

PRINCIPAL DISPLAY PANEL

RX ONLY

CRC

ANESTHETIC GEL

NDC: 66538-301-15

1/2 OZ. (15 ML)

Anesthetic Gel Label 001