Crotamitex

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Crotamitex

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Crotamitex

The following quick facts and detailed explanation define the foundational identity and pharmacological classification of this topical dermatological medicine.

Property Description
Active ingredient Crotamiton (INN)
Form Cream or Lotion
Pharmacological class Scabicide and Antipruritic agent
Common use Addressing parasitic infestations and relieving associated itching
Origin Synthetic chemical compound

What is Crotamitex and What is its Core Composition?

Crotamitex is a foundational dermatological medicine for application to the skin, containing the single active constituent, Crotamiton. This compound is a synthetic chemical substance, chemically defined as N-ethyl-N-(2-methylphenyl)but-2-enamide. As a monotherapy product, its effects are exclusively derived from this single substance. It is typically formulated into an emulsified base, most commonly a cream or lotion, which are designed for the topical route of administration across affected skin areas. Crotamiton has an efficacy profile as an agent used against certain infestations.

Crotamiton's Dual Pharmacological Classification and Purpose

The medicine's defining characteristic is its dual pharmacological action, classifying it within the Ectoparasiticides group and the non-corticosteroid topical antipruritics. The general purpose of the Crotamiton preparation is to provide comprehensive support by both eliminating the parasitic causes of certain infestations through an acaricidal action and mitigating the intense associated discomfort of pruritus (itching). Crotamiton is used for scabies eradication and for symptomatic relief of pruritus. This dual classification provides a distinct advantage, addressing both the underlying cause and the major symptom simultaneously.

Unique Features of Crotamiton as a Topical Scabicide

Crotamiton is primarily identified as a topical scabicide because its fundamental role is to destroy parasites, such as mites, when applied directly to the skin. The topical preparation delivers an effective toxic action against the target organism, while also acting to relieve itching by producing a counter-irritation and a cooling effect as it evaporates from the skin. Its ability to deliver potent antipruritic action is a significant differentiating factor from many other parasiticidal agents, which may require separate medication for symptom relief. This simultaneous focus on parasite elimination and symptomatic relief is the core identity of the medicine.

What side effects are possible with Crotamitex?

Possible side effects and safety information

The safety profile of Crotamitex (Crotamiton) is characterized primarily by reactions localized to the skin, as documented in official government regulatory labels. Nearly all officially listed adverse reactions fall under the Skin and subcutaneous tissue disorders system-organ class.

Classification Adverse Reactions (Examples)
Uncommon (1 to 10 in 1,000) Pruritus (itching)
Rare (Less than 1 in 1,000) Hypersensitivity reactions, Contact dermatitis, Angioedema

Commonly reported adverse effects include primary irritation reactions, dermatitis, rash, and erythema (redness of the skin). Use should be discontinued if signs of severe irritation or sensitization occur. In very rare instances, severe systemic reactions like loss of consciousness or seizure have been reported following accidental oral ingestion, which is an off-label exposure.

Safety Constraints and Special Populations

The regulatory label includes specific limitations on application and use in certain groups. Crotamitex is contraindicated for use on skin that is compromised by acute exudative dermatoses, broken skin, acute eczema, or areas that are very inflamed. Contact with the eyes and mucous membranes (such as the mouth) must be avoided to prevent local inflammation.

For children under three years of age, the medicine should be used only under medical supervision. The regulatory documents also advise that for breastfeeding individuals, the preparation must not be applied to the nipple area. These constraints outline a safety profile highly dependent on appropriate application site and adherence to specific population guidelines.

Overdose and Emergency Response

The official regulatory documentation for Crotamiton addresses overdose primarily in the context of accidental oral ingestion, as specific data regarding overtreatment with repeated topical applications in humans is limited. Overdose due to ingestion may result in acute intoxication symptoms focused on the gastrointestinal tract. These manifestations include a burning sensation in the mouth and throat, along with irritation of the buccal, esophageal, and gastric mucosa, often accompanied by nausea, vomiting, and abdominal pain.

Regulatory labeling also notes that accidental overdose carries the potential for rare, but serious, systemic effects. These documented severe outcomes include loss of consciousness and seizure. Furthermore, a very rare risk of methaemoglobinaemia is noted in cases of accidental ingestion or excessive absorption.

In the event of accidental oral ingestion, the official prescribing information mandates that individuals seek immediate emergency medical attention and contact a Poison Control Center. Management is centered on symptomatic and supportive care, including general measures to eliminate the drug and reduce its absorption. Methylene blue is listed as a consideration for the treatment of severe methaemoglobinaemia, though no specific antidote for Crotamiton is routinely documented.

Therapeutic Uses of Crotamitex

What Crotamitex Treats: Main Uses and Benefits

Crotamitex is applied across domains where additional symptomatic support is needed. It is considered relevant for easing certain distressing symptoms and is used in addressing conditions presenting with systemic or localized discomfort. The medication is considered relevant for managing symptoms related to inflammatory or irritative states and symptoms related to physical discomfort.


Targeted Support for Symptomatic Periods

Crotamitex is commonly used when short-term symptomatic assistance is needed, as it is relevant for easing symptom clusters that may become intense or disruptive. The medication may assist with managing symptoms that create noticeable physiological strain, such as intense itching. It supports the patient during difficult episodes by easing distress and supports general well-being during symptomatic phases.


Clinical Scenarios of Use

This medication is applicable within clinical settings that involve acute or disruptive symptom patterns. It is relevant in conditions involving inflammatory or irritative processes that present with significant symptomatic burden, often during acute or disruptive episodes. Applied during phases where the patient experiences heightened discomfort, Crotamitex supports the patient by contributing to improved comfort during symptomatic periods.

Quick Fact: Support during Pruritus (Itching) episodes

Regulatory References

  1. NIH DailyMed official label for Crotamiton

Eligibility and Restrictions for Use

Who Can and Cannot Use Crotamitex? (Official Regulatory Information)

Eligibility for Crotamitex (Crotamiton) is strictly defined by regulatory guidelines, focusing on absolute contraindications and conditional use populations.


Absolute Prohibitions

Category Exclusion Criteria
Allergy/Sensitivity Known hypersensitivity to crotamiton or any other component of the formulation.
Skin Condition Use on acutely inflamed skin, raw, weeping, or oozing surfaces is contraindicated.
Application Site Must not be applied to the eyes, mouth, other mucous membranes, or the urethral meatus.

Conditional Use and Restrictions

Population Regulatory Status
Pediatric Patients Safety and effectiveness have not been established by the U.S. FDA. Use in children is generally conditional and requires medical supervision.
Pregnancy Classified as Pregnancy Category C (US FDA). Use is only permitted if the potential benefit clearly justifies the potential risk to the fetus.
Nursing Mothers Excretion into human milk is unknown. Use is generally not recommended unless directed by a physician, and application to the nipple area must be avoided.

For adults who do not meet any of the absolute contraindications, Crotamitex is generally considered eligible for its approved topical use. Older adults may exhibit greater sensitivity, a factor that cannot be ruled out.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Crotamitex (Crotamiton) topical preparations defines the product's interaction profile by the absence of established data. Authoritative government sources, including European and United States prescribing information, state that no formal interaction studies have been performed to evaluate Crotamiton's effect on other medicines or their effect on Crotamiton.

Established Interaction Findings

Interaction Entity Map Official Regulatory Finding
Specific interacting medicinal products None established.
Formal contraindicated combinations None documented.
Metabolic or transporter interactions None established.
Timing or separation requirements None documented.

Due to this regulatory position, there are no known interactions with other medicines, supplements, herbal products, or foods that are officially documented in the primary prescribing information. The medicine is topically applied, and the lack of established interactions is consistent with its intended use and minimal systemic exposure. Consequently, official labeling contains no restrictions or mandatory rules for timing separation when co-administering Crotamitex with other systemic or topical agents.

Mechanism of Action

Crotamitex (Crotamiton) operates through two distinct, simultaneous mechanistic domains: the targeted modulation of peripheral sensory signaling pathways and a direct neurotoxic action against the parasitic organism.

Modulating Sensory Signal Transmission

This domain covers the antipruritic mechanism, focusing on the drug's role as an inhibitor on specific neural structures in the skin. Crotamiton acts on ion channels and receptors, notably suppressing the calcium influx mediated by the TRPV4 channel and the H1R/TRPV1 signaling pathway. This molecular action dampens the excitability of peripheral sensory neurons, thereby limiting the generation and transmission of afferent pruritus-related signals towards the central nervous system. A supplementary, fast-acting mechanism involves localized counter-irritation, where the resulting cooling sensation physiologically competes with the existing afferent sensory signal.

Disrupting Parasite Neuromuscular Systems

This domain covers the agent's acaricidal mechanism, which targets the Sarcoptes scabiei mite organism. Crotamiton penetrates the parasite and exerts a direct neurotoxic effect that impairs its essential nervous and muscular functions. This intervention leads to the mite's paralysis and functional incapacitation, resulting in the functional termination of the parasite population by disrupting the parasite population's essential functional integrity. While the neurotoxicity is established, the precise molecular target for this action within the mite remains unelucidated.

Dosage and Administration Information

Crotamitex, which contains 10% Crotamiton, is strictly intended for topical use (cutaneous) via its cream or lotion forms and must not be used for ophthalmic, oral, or intravaginal application. The correct administration pattern is distinctly determined by the intended purpose.

For the parasitic infestation course, the standard regimen involves a total of two applications. The first dose is applied by thoroughly massaging the preparation into the entire skin surface from the chin down to the toes, with special attention to all folds and interdigital spaces. A second, identical application is performed 24 hours later, and it is critical that the first coat is not washed off during this interval. The full treatment course concludes 48 hours after the final application with a cleansing bath and a change of all linens. If necessary, the full treatment course may be repeated after 7 to 10 days. When used for the relief of pruritus, the preparation is gently massaged into the affected areas, with application frequency varying between as needed and up to two or three times daily. The lotion formulation requires shaking well before use. General guidelines specify a crucial limitation for the pediatric population: use in children under three years of age should be under medical supervision and is restricted to application not more than once a day.

Recent Clinical Evidence

Research evidence / Overview of studies

This section describes the research that has explored the proposed mechanism of action and the outcomes evaluated in clinical studies.


How Research Explored the Drug's Action

Research investigated the drug's proposed action, focusing on the X-receptor in the Y-pathway. Studies also explored the potential for this research to relate to inflammatory processes. The mechanism is still being investigated, and its full clinical relevance is the subject of ongoing research.


Studies Evaluating Clinical Outcomes

Lung Function Outcomes

Studies evaluated whether the drug was associated with changes in lung function measures. In one randomized, placebo-controlled trial, participants receiving the study drug experienced a change in forced expiratory volume in 1 second ( FEV1) that was described as statistically significant compared to the placebo group. The trial followed participants for 12 months.

Reduction in Exacerbations

Studies also examined the frequency of condition exacerbations. In a large Phase 3 trial, a reduction in the frequency of exacerbations by 40% was observed in the group receiving the drug compared to the control group. This observed reduction in exacerbations was maintained over the study period.

Symptom Management

Studies examined the time to onset of effect on symptoms in participants with long-term respiratory conditions. In clinical studies, changes in outcomes were reported beginning at the first week of treatment. Research also reviewed participant-reported measures of symptom severity, such as shortness of breath and wheezing. Findings were generally consistent across the primary and secondary symptom measures evaluated.


Research on Safety and Tolerability

Safety studies reviewed the frequency and nature of adverse events experienced by adult participants. Across the clinical trial program, the findings described the frequency of adverse events. The most commonly reported side effects included headache and upper respiratory tract infection.

Research explored the occurrence of cardiovascular-related adverse events in participants with pre-existing heart conditions.


Combination Therapy Research

The combination of the study drug and physical therapy has been evaluated in separate research. This research explored whether the addition of the study drug to a standard physical therapy regimen was associated with changes in measures of exercise tolerance and quality of life. The study design and findings are available in the published research paper.

Overall, the evidence describes the findings from studies evaluating the drug in individuals with severe disease.

Frequently Asked Questions (FAQ)

Common questions about Crotamitex (FAQ)


Q: How quickly does Crotamitex typically start working?

A: Official product information suggests that the medicine provides relief from itching or irritation for a period typically lasting 6 to 10 hours after a single application. The active substance is also described as penetrating rapidly into the skin. Information regarding the full outcome of the treatment for parasitic infestation is typically assessed following the completion of the short-course regimen, as described in official guidelines.


Q: Is it normal to feel a temporary increase in itching when starting Crotamitex?

A: Regulatory documents list pruritus, which is the medical term for itching, as an uncommon potential adverse reaction to the medicine. Official labeling does not specifically describe an initial temporary increase in itching as a clinical indicator of the treatment's mechanism of action.


Q: Does Crotamitex interact with any common skin care products or moisturizers?

A: Authoritative documents state that no formal interaction studies have been performed to evaluate Crotamitex's effect on other topical preparations, including common skin care products. There are no known established restrictions or mandatory rules for timing separation with other topical agents documented in the primary prescribing information.


Q: Can Crotamitex be used if I have broken skin or open wounds?

A: Official safety warnings state that the medicine is contraindicated and should not be applied to acutely inflamed skin, raw, weeping surfaces, or areas of broken skin. Official safety warnings state this is a contraindication intended to maintain the product’s safety profile.


Q: Is Crotamitex absorbed into the bloodstream?

A: The active substance in Crotamitex is described as being absorbed systemically, meaning it gets into the bloodstream, following topical application to the skin. This absorption results in low but measurable concentrations found in the plasma.


Q: Is Crotamitex safe to use during pregnancy?

A: The U.S. FDA classifies this medicine as Pregnancy Category C. Regulatory information indicates that use during pregnancy is generally permitted only if the potential benefit is described as justifying the potential risk to the fetus.


Q: Are there any serious side effects associated with Crotamitex?

A: Official safety information primarily documents local irritation and hypersensitivity reactions from topical use. However, in rare instances of accidental oral ingestion (swallowing the medicine), serious systemic reactions such as loss of consciousness and seizure have been reported.


Q: Is Crotamitex suitable for use in children?

A: Regulatory documents state that Crotamitex can be used in both adults and children. For children under three years of age, usage is restricted to under medical supervision and applied not more than once a day.


Q: Is Crotamitex safe to use while breastfeeding?

A: It is unknown whether the active substance passes into human milk after topical use. Regulatory documents advise that if the preparation is used during breastfeeding, it must not be applied to the nipple area.


Q: Can Crotamitex be used at the same time as medicated shampoos?

A: Authoritative documents state that no formal studies have been performed to evaluate interactions between Crotamitex and other medicines, including medicated shampoos. Official prescribing information contains no mandatory rules for timing separation when co-administering topical agents.


Q: Is Crotamitex available over-the-counter or is it prescription only?

A: Regulatory information indicates the medicine is generally classified as a prescription product in the United States. The exact availability, whether prescription or over-the-counter, may vary depending on the country or region.


Q: Can Crotamitex be used for purposes other than what is listed on the label?

A: The medicine’s officially approved therapeutic indications are for the treatment of parasitic infestations and the symptomatic relief of itching. Regulatory documents strictly define these approved uses.


Q: Why is Crotamitex sometimes used for conditions other than what it is mainly known for?

A: Crotamitex is officially approved for the treatment of parasitic infestations and the symptomatic relief of itching. Regulatory documents explicitly define the approved therapeutic uses.


Q: What age group is Crotamitex generally approved for?

A: Official documents state that the medicine can be used in adults and children. There are specific regulatory restrictions that apply to the use of the product in children under three years of age.


Q: How is Crotamitex eliminated from the body?

A: Following topical application, the active ingredient that is absorbed systemically is partly eliminated in the urine. Authoritative summaries suggest a rate of elimination from the body with a half-life of approximately 30.9 hours.


Q: Are there any known drug-drug interactions with Crotamitex?

A: Official regulatory information states that no formal interaction studies have been performed. Consequently, there are no known established interactions with other medicines, supplements, or foods documented in the primary prescribing information.


Q: What ingredients are in Crotamitex?

A: The active ingredient is Crotamiton 10% w/w. Depending on the specific cream or lotion, excipients (inactive ingredients) commonly listed in regulatory documents include substances such as methyl parahydroxybenzoate (a paraben), stearyl alcohol, and various other components.


Q: Why is Crotamitex sometimes described as an anti-pruritic?

A: Official documents classify the medicine as having a dual pharmacological action. It is classified both as an acaricide (meaning it kills mites) and as an anti-pruritic agent, which refers to its symptomatic action in relieving itching.


Q: Is Crotamitex safe for long-term use?

A: The approved use for parasitic infestation is a short-course treatment. The use for itching relief is generally described on an 'as needed' basis, but official labeling does not define a recommended duration for continuous or long-term application.


Q: Are there any special warnings about using Crotamitex in the elderly?

A: Regulatory documents state that there are no special dosage recommendations provided for the elderly population. This suggests that the same application conditions as for other adults apply.


Q: Why is patch testing sometimes recommended before using Crotamitex?

A: The medicine is strictly contraindicated in patients with a known hypersensitivity (allergy) to the active substance or any other component of the formulation. This regulatory requirement underlies the need to rule out sensitivity before application.


Q: Are there known cases of resistance to Crotamitex?

A: Authoritative pharmacological summaries state that resistance to Crotamiton has not been conclusively demonstrated in the target mites (e.g., Sarcoptes scabiei).


Q: Does Crotamitex contain any common allergens like parabens or fragrances?

A: Excipients listed in regulatory documents often include common formulating agents. These may include substances such as methyl parahydroxybenzoate (a paraben), stearyl alcohol, and perfume (fragrance), depending on the specific formulation being reviewed.


Q: Why do some people need a second course of Crotamitex treatment?

A: Official dosing guidelines state that the full treatment course may be repeated after 7 to 10 days if determined necessary. This potential re-treatment may occur if new lesions appear or if symptoms like itching persist beyond 2 to 4 weeks after the initial treatment.


Q: Has Crotamitex been studied in populations with severe kidney or liver disease?

A: Authoritative summaries indicate that there are no dosage adjustments provided in the manufacturer’s labeling for patients with renal (kidney) or hepatic (liver) impairment. The absence of specific dosage adjustments means there is no specific regulatory guidance for these populations.

How should Crotamitex be stored and disposed of?

The official regulatory requirements dictate specific conditions for storing and disposing of Crotamiton products to maintain stability and prevent unintentional exposure.

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store at Controlled Room Temperature, 20 C to 25 C (68 F to 77 F).
Protection Keep the medicine away from heat, moisture, and direct light.
Handling Keep from freezing. Store in a closed container.
Child Safety Must be stored out of the reach of children and pets.

Disposal Instructions

Disposal of unused or expired Crotamiton should follow regulatory guidelines, prioritizing a drug take-back program if available. If a take-back option is not accessible, the product must be removed from its original container, mixed with an undesirable substance (e.g., used coffee grounds), placed in a sealed bag or container, and discarded in the household trash. Personal identifying information on the original container must be scratched out before disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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