Label: EURAX- crotamiton cream
- NDC Code(s): 69489-311-60
- Packager: Journey Medical Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 17, 2025
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- Official Label (Printer Friendly)
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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 cisand transisomers. Its molecular weight is 203.28.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
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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.
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.
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.
- ADVERSE REACTIONS
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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. -
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.
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HOW SUPPLIED
Eurax ®(crotamiton, USP) Cream, 10% is a white to yellowish-white soft cream and supplied as:
60 g tube NDC 69489-311-60Store 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.comEUR-P01-R00 Revised 12/2025
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EURAX
crotamiton creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69489-311 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROTAMITON (UNII: D6S4O4XD0H) (CROTAMITON - UNII:D6S4O4XD0H) CROTAMITON 100 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208) LAURETH-23 (UNII: N72LMW566G) BENZYL ALCOHOL (UNII: LKG8494WBH) STEARETH-2 (UNII: V56DFE46J5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) PETROLATUM (UNII: 4T6H12BN9U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69489-311-60 1 in 1 CARTON 03/16/2026 1 60 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 NDA NDA006927 03/16/2026 Labeler - Journey Medical Corporation (079640860) Registrant - Journey Medical Corporation (079640860) Establishment Name Address ID/FEI Business Operations DPT Laboratories, Ltd 832224526 analysis(69489-311) , label(69489-311) , manufacture(69489-311) , pack(69489-311)
