NDC Code(s) : 65923-149-01
Packager : United Exchange Corporation

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Coralite Odor Free Pain ReliefLidocaine PATCH
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-149
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS(UNII: 1K713C615K)
ALCOHOL(UNII: 3K9958V90M)
KAOLIN(UNII: 24H4NWX5CO)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TARTARIC ACID(UNII: W4888I119H)
SODIUM POLYACRYLATE (2500000 MW)(UNII: 05I15JNI2J)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65923-149-011 in 1 POUCH 29/10/2018
11 g in 1 PATCH Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M017 10/29/2018

LABELER - United Exchange Corporation(840130579)

PRINCIPAL DISPLAY PANEL

90159