Crotamiton

Indications

Pruradik ™ (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: Pruradik 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION: SHAKE WELL BEFORE USE. 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. Clothing and bed linen should be changed the next morning. A cleansing bath should be taken 48 hours after the last application. In Pruritis: Massage gently into affected areas until medication is completely absorbed. Repeat as needed. DIRECTIONS FOR PATIENTS WITH SCABIES: 1. Take a routine bath or shower. Thoroughly massage Pruradik ™ lotion into the skin from the chin to the toes including folds and creases. 2.

Contraindications

CONTRAINDICATIONS: Pruradik lotion should not be applied topically to patients who develop a sensitivity or are allergic to it or who manifest a primary irritation response to topical medications.

Warnings and precautions

FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx ONLY

Pregnancy

Pregnancy (Category C): Animal reproduction studies have not been conducted with Pruradik (crotamiton USP) lotion. It is also not known whether Pruradik can cause fetal harm when applied to a pregnant woman or can affect reproduction capacity. Pruradik should be given to a pregnant woman only if clearly needed.

Storage and supply

STORAGE: Store 20 ° to 25 º C (68 ° - 77 ° F). Excursions allowed between 15 ° and 30 ° C (59 ° and 86 ° F) .

Source: Crotamiton (Pruradik) — US FDA prescribing information, 2025-06-02, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.