Official product label reference
Eurax — Journey Medical Corporation
This page contains 18 source sections for CROTAMITON, topical route. Label set 99c826aa-c7dd-4e60-be9c-e9c151033d13, version 2.
Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label
Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.
Uses described in the label
INDICATIONS AND USAGE For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.
Dosage and administration — label text
DOSAGE AND ADMINISTRATION In Scabies: Thoroughly massage into the skin of the whole body from the chin down, paying particular attention to all folds and creases. A second application is advisable 24 hours later. Change clothing and bed linen the next morning. Take a cleansing bath 48 hours after the last application. In Pruritus: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: Take a routine bath or shower. Thoroughly massage Eurax cream into the skin from the chin to the toes including folds and creases. Put Eurax cream under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax cream under the fingernails. Immediately after use, wrap the toothbrush in paper and throw it away. Use of the same brush in the mouth could lead to poisoning. A second application is advisable 24 hours later. A 60 gram tube is sufficient for two applications. Change clothing and bed linen the next day. Dry clean contaminated clothing and bed linen, or wash in the hot cycle of the washing machine. Take a cleansing bath 48 hours after the last application.
Contraindications
CONTRAINDICATIONS Do not apply Eurax topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.
Warnings
WARNINGS Discontinue treatment with this product if severe irritation or sensitization develops, and institute appropriate therapy.
Adverse reactions
ADVERSE REACTIONS Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
Drug interactions
Drug Interactions None known.
Product description
DESCRIPTION Eurax (crotamiton, USP) is a scabicidal and antipruritic agent available as a cream for topical use only. Eurax provides 10% (w/w) of the synthetic, crotamiton, USP, in a vanishing-cream base containing: carbomer homopolymer type B, cetyl alcohol, diazolidinyl urea, dimethicone, glyceryl monostearate, laureth-23, magnesium aluminum silicate, benzyl alcohol, petrolatum, propylene glycol, sodium hydroxide, steareth-2, and water. Crotamiton is N-ethyl-N-( o -methylphenyl)-2-butenamide and its structural formula is: Crotamiton, USP is a colorless to slightly yellowish oil, having a faint amine-like odor. It is soluble with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203.28. structurenew
Clinical pharmacology
CLINICAL PHARMACOLOGY Eurax has scabicidal and antipruritic actions. The mechanisms of these actions are not known. The pharmacokinetics of crotamiton and its degree of systemic absorption following topical application have not been determined.
Precautions
PRECAUTIONS General Do not apply Eurax in the eyes or mouth because it may cause irritation. Do not apply on acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided. Information for Patients See DIRECTIONS FOR PATIENTS WITH SCABIES. Drug Interactions None known. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals have not been conducted. Pregnancy Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies with Eurax (crotamiton, USP) Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
General precautions
General Do not apply Eurax in the eyes or mouth because it may cause irritation. Do not apply on acutely inflamed skin or raw or weeping surfaces until the acute inflammation has subsided.
Information for patients
Information for Patients See DIRECTIONS FOR PATIENTS WITH SCABIES.
Carcinogenesis and mutagenesis and impairment of fertility
Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies in animals have not been conducted.
Pregnancy
Pregnancy Animal reproduction studies have not been conducted with Eurax. It is also not known whether Eurax can cause fetal harm when applied topically to a pregnant woman or can affect reproduction capacity. Eurax should be given to a pregnant woman only if clearly needed.
Children and adolescents
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
Older adults
Geriatric Use Clinical studies with Eurax (crotamiton, USP) Cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Overdose information
OVERDOSAGE There is no specific information on the effect of overtreatment with repeated topical applications in humans. A death was reported but cause was not confirmed. Accidental oral ingestion may be accompanied by burning sensation in the mouth, irritation of the buccal, esophageal and gastric mucosa, nausea, vomiting, abdominal pain. If accidental ingestion occurs, call your Poison Control Center.
Instructions for use
DIRECTIONS FOR PATIENTS WITH SCABIES: Take a routine bath or shower. Thoroughly massage Eurax cream into the skin from the chin to the toes including folds and creases. Put Eurax cream under fingernails after trimming the fingernails short, because scabies are very likely to remain there. A toothbrush can be used to apply the Eurax cream under the fingernails. Immediately after use, wrap the toothbrush in paper and throw it away. Use of the same brush in the mouth could lead to poisoning. A second application is advisable 24 hours later. A 60 gram tube is sufficient for two applications. Change clothing and bed linen the next day. Dry clean contaminated clothing and bed linen, or wash in the hot cycle of the washing machine. Take a cleansing bath 48 hours after the last application.
Supply and packaging
HOW SUPPLIED Eurax ® (crotamiton, USP) Cream, 10% is a white to yellowish-white soft cream and supplied as: 60 g tube NDC 69489-311-60 Store at room temperature, 20˚C - 25˚C (68˚F - 77˚F); Excursions permitted: 15˚C - 30˚C (59˚F - 86˚F) [See USP Controlled Room Temperature]. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact Journey Medical Corporation at 1-855-531-1859 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: Journey Medical Corporation Scottsdale, AZ 85258 www.JMCderm.com EUR-P01-R00 Revised 12/2025 logo
Official sources and product identifiers
- DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
- openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.
- Drugs@FDA application NDA006927Application history where available; verify the specific product and indication.
Substances listed: CROTAMITON
RxNorm identifiers: 207864, 309552
Package NDC codes
69489-311-60
Further research and background
These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.
Coverage and corrections
The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.
Source retrieved 2026-10-02. Read the source policy.