Elimite (Page 2 of 2)

HOW SUPPLIED

ELIMITE™ 5% Cream is available as follows:

60 g tube (NDC 40076-115-60)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Prestium Pharma

Manufactured for Prestium Pharma, Inc.

Newtown, PA 18940

by Perrigo Pharmaceuticals, Allegan, MI 49010

Rev. 08/15

: 1T600 ZH JX1

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- Carton

ELIMITE™ CREAM

(PERMETHRIN) 5%*

*W/W

FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.

Rx Only

60 g

ELIMITE CREAM CARTON
(click image for full-size original)
ELIMITE
permethrin 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 (PERMETHRIN) PERMETHRIN 50 mg in 100 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
MEDIUM-CHAIN TRIGLYCERIDES
GLYCERIN
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
LANOLIN ALCOHOLS
MINERAL OIL
WATER
SODIUM HYDROXIDE
FORMALDEHYDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40076-115-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (40076-115-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076369 10/24/2012
Labeler — Prestium Pharma, Inc. (078304674)

Revised: 05/2016 Prestium Pharma, Inc.

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