Crotamiton
FDA Drug Information • Also known as: Crotan, Eurax, Pruradik
- Brand Names
- Crotan, Eurax, Pruradik
- Route
- TOPICAL
- Dosage Form
- LOTION
- Product Type
- HUMAN PRESCRIPTION DRUG
What Is Crotamiton Used For?
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.
Dosage and Administration
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 CROTAN ™ lotion into the skin from the chin to the toes including folds and creases. 2. Put CROTAN lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply the CROTAN lotion under the fingernails. Immediately after use, the toothbrush should be wrapped in paper and thrown away. Use of the brush in the mouth could lead to poisoning. 3. A second application is advisable 24 hours leater. 4. Clothing and bed linen should be changed the next day. Contaminated clothing and bed linen may be dry-cleaned or washed in the hot cycle of the washing machine. 5. A cleansing bath should be taken 48 hours after the last application.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS: Primary irritation reactions such as dermatitis, pruritus and rash, and allergic sensitivity reactions have been reported in a few patients. To report SUSPECTED ADVERSE REACTIONS, contact Marnel Pharmaceuticals at 1-888-850-2905 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings and Precautions
WARNINGS: If severe irritation or sensitization develops, treatment with this product should be discontinued and appropriate therapy instituted.
Drug Interactions
Drug Interactions: None known.
Contraindications
CONTRAINDICATIONS: CROTAN 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.
Pregnancy and Breastfeeding
Pregnancy (Category C): Animal reproduction studies have not been conducted with CROTAN (crotamiton USP) lotion. It is also not known whether CROTAN can cause fetal harm when applied to a pregnant woman or can affect reproduction capacity. CROTAN should be given to a pregnant woman only if clearly needed.
Overdosage
OVERDOSAGE: There is no specific informaton 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.
How Supplied
HOW SUPPLIED: CROTAN (crotamitan USP) lotion, 10% is available in: 60 gm ( NDC: 0682-0051-20) 237 gm ( NDC : 0682-0051-10) 454 gm ( NDC : 0682-0051-30) Rx ONLY Mfd For: Marnel Pharmaceuticals LLC Charleston, South Carolina USA 888-850-2905 Rev July 2021
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.