ELIMITE (Page 2 of 2)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5% Container Label (60 g Tube)

NDC 59651-834-60
Rx only
ELIMITE® CREAM
(PERMETHRIN)
5%*

*W/W
FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.
AUROBINDO 60 g

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5% Container Label (60 g Tube)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5% Container Carton Label (60 g Tube)

NDC 59651-834-60
Rx only
ELIMITE® CREAM
(PERMETHRIN)
5%*

*W/W
FOR EXTERNAL USE ONLY. NOT FOR USE IN EYES.
AUROBINDO 60 g

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 5% Container Carton Label (60 g Tube)
(click image for full-size original)

ELIMITE permethrin cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-834
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PERMETHRIN (PERMETHRIN) PERMETHRIN 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)
CETETH-2
CETETH-20
GLYCERIN
ISOPROPYL MYRISTATE
LANOLIN ALCOHOLS
MEDIUM-CHAIN TRIGLYCERIDES
MINERAL OIL
GLYCERYL MONO AND DIPALMITOSTEARATE
WATER
SODIUM HYDROXIDE
FORMALDEHYDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-834-60 1 TUBE in 1 CARTON contains a TUBE
1 60 g in 1 TUBE This package is contained within the CARTON (59651-834-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019855 01/22/2024
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 878100017 ANALYSIS (59651-834), MANUFACTURE (59651-834)

Revised: 01/2024 Aurobindo Pharma Limited

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