NDC Code(s) : 55700-421-30
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine HydrochlorideLidocaine GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-421(NDC:35781-2500)
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
FILIPENDULA ULMARIA FLOWER (UNII: 06L18L32G6)
QUERCUS ALBA WOOD(UNII: XR6BC2ZUAM)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
WATER(UNII: 059QF0KO0R)
ZINC ACETATE(UNII: FM5526K07A)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55700-421-301 in 1 CARTON 07/05/2016
130 g in 1 TUBE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Premarket Notification K092086 05/01/2016

PRINCIPAL DISPLAY PANEL

Image of Label