CROTAMITON: 29 Adverse Event Reports & Safety Profile
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Route: TOPICAL · Manufacturer: Marnel Pharmaceuticals, Inc. · FDA Application: 006927 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20140104 · Latest Report: 20250301
What Are the Most Common CROTAMITON Side Effects?
All CROTAMITON Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pruritus | 14 | 48.3% | 0 | 1 |
| Skin burning sensation | 9 | 31.0% | 0 | 0 |
| Urticaria | 9 | 31.0% | 0 | 0 |
Who Reports CROTAMITON Side Effects? Age & Gender Data
Gender: 65.4% female, 34.6% male. Average age: 53.7 years. Most reports from: GB. View detailed demographics →
Is CROTAMITON Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 4 | 1 | 2 |
| 2015 | 1 | 0 | 0 |
| 2016 | 2 | 0 | 0 |
| 2020 | 1 | 1 | 0 |
| 2021 | 4 | 0 | 0 |
| 2023 | 1 | 0 | 1 |
| 2024 | 1 | 0 | 0 |
| 2025 | 9 | 0 | 0 |
What Is CROTAMITON Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 17 |
Official FDA Label for CROTAMITON
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (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 & 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 Pruradik ™ lotion into the skin from the chin to the toes including folds and creases. 2.
Put
Pruradik lotion under fingernails after trimming the fingernails short, because scabies are likely to remain there. A toothbrush can be used to apply the Pruradik 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.
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.
Known 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
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx ONLY
Precautions
PRECAUTIONS: General: Pruradik lotion should not be applied in the eyes or mouth because it may cause irritation. It should not be applied to acutely inflamed skin or raw or weeping surfaces until acute inflammation has subsided.
Drug Interactions
Drug Interactions: None known.