INDICATIONS AND USAGE: For eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin.
SUMMARY OF RISK INFORMATION FOR EURAX CREAM
CONTRAINDICATIONS: Do not apply EURAX topically to patients who develop sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.
WARNINGS: Discontinue treatment with this product if severe irritation or sensitization develops, and institute appropriate therapy.
PRECAUTIONS: 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.
It is 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.
PRECAUTIONS: Safety and effectiveness in pediatric patients have not been established.
Clinical studies with EURAX did not include sufficient numbers of subjects aged 65 years and older to determine whether they
respond differently than younger subjects.
ADVERSE REACTIONS: Primary irritation reactions, such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
This preparation is not for ophthalmic, oral, or intravaginal use.
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.
For topical use only. Please see Full Prescribing Information.