NDC Code(s) : 40076-115-60
Packager : Prestium Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

elimitePermethrin CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40076-115
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERMETHRIN(UNII: 509F88P9SZ)
(PERMETHRIN - UNII:509F88P9SZ) 		PERMETHRIN50 mg in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: HHT01ZNK31)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
LANOLIN ALCOHOLS(UNII: 884C3FA9HE)
MINERAL OIL(UNII: T5L8T28FGP)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
FORMALDEHYDE(UNII: 1HG84L3525)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:40076-115-601 in 1 CARTON
160 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
ANDA ANDA076369 10/24/2012

PRINCIPAL DISPLAY PANEL

ELIMITE™ CREAM

(PERMETHRIN) 5%*

*W/W

FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.

Rx Only

60 g

ELIMITE CREAM CARTON