NDC Code(s) : 76344-0101-1, 76344-0101-2
Packager : Humex,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ANESTALIDOCAINE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76344-0101
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
TRIDECETH-10(UNII: G624N6MSBA)
CHOLESTEROL(UNII: 97C5T2UQ7J)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
BENZYL ALCOHOL(UNII: LKG8494WBH)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE(UNII: VLW429K27K)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
TROLAMINE(UNII: 9O3K93S3TK)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76344-0101-21 in 1 PACKAGE 01/01/2016
1NDC:76344-0101-1120 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 01/01/2016

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL