Eurax

Treats pruritic skin. NDA 6927, held by Journey. Crotamiton.

As of Nov 13, 2026, NDA 6927 (Eurax), held by Journey, was first approved by FDA on Jul 6, 1949, with 24 approved supplements and 0 published complete response letters.

First approved: Jul 6, 1949
Supplements approved: 24
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 25 submissions below

Date	Submission	Status	Documents
Jul 6, 1949	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Eurax10% · cream;topical	Crotamiton	RxReference drug

All 25 submissions, including labeling and manufacturing supplements


Oct 30, 2013	Supplement 33Manufacturing	Approved	None posted
Jun 26, 2003	Supplement 30Labeling	Approved	Label Letter
May 23, 2002	Supplement 29Manufacturing	Approved	None posted
Aug 25, 1989	Supplement 27Manufacturing	Approved	None posted
Mar 13, 1987	Supplement 28Manufacturing	Approved	None posted
Nov 26, 1984	Supplement 26Manufacturing	Approved	None posted
Jun 12, 1984	Supplement 25Manufacturing	Approved	None posted
May 8, 1984	Supplement 24Manufacturing	Approved	None posted
Mar 6, 1984	Supplement 23Manufacturing	Approved	None posted
Sep 9, 1983	Supplement 17Labeling	Approved	None posted
Feb 4, 1983	Supplement 22Manufacturing	Approved	None posted
Jun 30, 1982	Supplement 21Manufacturing	Approved	Letter Label
May 28, 1982	Supplement 20Manufacturing	Approved	None posted
Jun 4, 1981	Supplement 19Labeling	Approved	None posted
Jan 10, 1980	Supplement 15Labeling	Approved	None posted
Mar 12, 1979	Supplement 16Manufacturing	Approved	None posted
Oct 5, 1978	Supplement 14Labeling	Approved	None posted
Oct 27, 1977	Supplement 9Manufacturing	Approved	None posted
Oct 27, 1977	Supplement 10Manufacturing	Approved	None posted
Oct 27, 1977	Supplement 11Manufacturing	Approved	None posted
Oct 27, 1977	Supplement 12Manufacturing	Approved	None posted
Oct 27, 1977	Supplement 13Manufacturing	Approved	None posted
Nov 13, 1975	Supplement 7Manufacturing	Approved	None posted
Nov 13, 1975	Supplement 8Labeling	Approved	None posted
Jul 6, 1949	Original application	Approved	None posted

Identifiers

Application: NDA 6927
Drugs@FDA: Overview at FDA
Company: Journey Medical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters