For the eradication of scabies (Sarcoptes scabiei) and for symptomatic treatment of pruritic skin
Crotan Lotion (Crotamiton USP 10%) should not be applied topically to patients who develop sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.
If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Crotan Lotion (Crotamiton USP 10%) should not be applied to the eyes or mouth because it may cause irritation, If should not be applied to acutely inflamed skin or raw or weeping surface until the acute irritation has subsided.
It is not know whether Crotan Lotion (Crotamiton USP 10% )can cause fetal harm when applied topically to a pregnant woman or if it affects reproduction capacity. Crotan Lotion (Crotamiton USP 10%) should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in pediatric patients have not been established.
Clinical studies with Crotan Lotion (Crotamiton USP 10%) did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger patients.
Primary irritation reaction such as dermatitis, pruritus, and rash, and allergic sensitivity reactions have been reported in a few patients.
This preparation is not for opthalmic, oral or intravaginal use.
For topical use only. Please see Full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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