crotamiton

FDA Drug Profile — Eurax

Drug Details

Generic Name
crotamiton
Brand Names
Eurax
Application Number
NDA006927
Sponsor
Journey Medical Corporation
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
CROTAMITON

Indications and Usage

CROTAN ™ (crotamiton USP 10%) is a scabicidal and antipruritic agent as a lotion for topical use only. Crotamiton is a colorless to slightly yellowish oil, having a faint amine-like odor. It is miscible with alcohol and with methanol. Crotamiton is a mixture of the cis and trans isomers. Its molecular weight is 203. 28. Crotamiton is N-ethyl-N(o-methyl-phenyl) 2-butenamide and its structural formula is: CROTAN lotion contains crotamiton USP 10% (100mg/ml) in a creamy lotion base containing purified water, light mineral oil, propylene glycol, cetearyl alcohol (and) cetearth-20, cetyl alcohol, lanolin, benzyl alcohol, carbomer 971P, sodium hydroxide with citric acid (for pH adjustment). image description INDICATIONS AND USAGE: For eradication of scabies ( Sarcoptes scabiei ) and for symptomatic treatment of pruritic skin.

Warnings

WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.