Ichtholan 10%

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Ichtholan 10%

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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 Ichtholan 10%

Quick Facts

Property Description
Active ingredient Ichthammol (Ammonium bituminosulfonate)
Form Ointment (Salbe), 10% concentration
Pharmacological class Dermatologic Agent / Sulfonated Shale Oil
General purpose Management of localized skin inflammations
Origin Derived from natural oil-rich shale

What Type of Medicine is Ichtholan 10%?

Ichtholan 10% is a topical preparation that serves as a Dermatologic Agent, specifically belonging to the pharmacological class of Sulfonated Shale Oils. Its main function is characterized by mild local Antiseptic and Germicidal properties. The preparation is a single-ingredient product formulated as a dark, semi-solid Ointment intended exclusively for cutaneous application.

The active substance is also officially known as Ichthammol or Ammonium bituminosulfonate, which is a key chemical entity used in external applications. Its classification as a sulfonated shale oil derivative is recognized in regulatory contexts, supporting its identity as a traditional agent for addressing superficial skin concerns.


Composition and Origin of Ichtholan 10%

The sole active component of Ichtholan 10% is Ichthammol. This key ingredient is a derived substance with a natural origin, produced through the controlled distillation and sulfonation of specific oil-rich shale deposits. This process yields the unique sulfur-containing organic molecule responsible for the product's characteristic dark color.

The 10% concentration defines the strength of the Ichthammol component embedded within the inert, lipophilic ointment base, typically comprising substances like petrolatum. The compound's anti-inflammatory and antiseptic effects are associated with its clinically recognized role in soothing irritation. This underscores the ointment's function in promoting the resolution of superficial skin issues.


The General Purpose of This Topical Ointment

The general purpose of Ichtholan 10% is to support the management of localized discomfort associated with minor skin inflammations, such as irritated hair follicles. This utility is linked directly to the established physiological actions of the active compound, providing both a supportive anti-inflammatory and a mild antiseptic effect at the application site.

The preparation aids the skin's natural recovery processes. It is traditionally valued for its ability to help soothe the affected area and facilitate tissue maturation, a property often referred to as a drawing effect in the context of minor, confined skin issues.

What side effects are possible with Ichtholan 10%?

Possible Side Effects and Safety Information

The safety profile of Ichtholan 10% is primarily characterized by localized adverse reactions affecting the Skin and subcutaneous tissue disorders system, consistent with its function as a topical agent. The officially documented adverse events are generally restricted to the site of application.

Adverse Reaction Scope

Category Official Regulatory Statement
Key Adverse Reactions Local skin irritation (e.g., burning, redness, itching), allergic reactions, and contact dermatitis.
Frequency Classification Uncommon for allergic reactions, including contact dermatitis, according to European regulatory documents. Other effects may have a frequency of not known.
System-Organ Classes (SOC) Skin and subcutaneous tissue disorders only.
Serious Adverse Reactions Potential for severe allergic reactions (hypersensitivity), which forms the basis for the primary contraindication.

Safety Considerations and Restrictions

The risk of contact dermatitis is a duration-related safety pattern officially noted as being potentially associated with prolonged use of the preparation. This high-level safety information guides the understanding of the product’s risk.

A primary safety-related restriction listed in regulatory documents is the contraindication for use in cases of known hypersensitivity to the active ingredient, Ichthammol, or any of the formulation’s components. Furthermore, official safety notes mandate that the preparation is for external/cutaneous use only and must avoid contact with the eyes and mucous membranes.

Connection to the Overall Safety Profile

Official labeling rigorously structures the understanding of risk around localized cutaneous effects and the potential for a time-dependent allergic response. This focus dictates that the officially defined risks are highly restricted to the immediate application area, making hypersensitivity the principal constraint documented by regulatory authorities.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory classification for topical preparations like Ichtholan 10% indicates that overdose is primarily a concern for accidental oral ingestion, as excessive use on the skin is not documented to cause systemic toxicity. Should the ointment be swallowed, it is officially mandated to seek immediate medical attention or contact a Poison Control Center right away without delay. Urgent help is required if severe systemic symptoms, such as passing out or difficulty breathing, are observed following exposure.

Documented Systemic Manifestations (Accidental Ingestion):

Regulatory toxicity data defines specific systemic symptoms following ingestion of the active substance. These may include gastrointestinal effects such as nausea and vomiting, and neurological changes like dizziness and ataxia. Ingestion of a high amount has been reported to cause severe, life-threatening effects, including acute pulmonary oedema and coma.

Management and Treatment:

Treatment for documented systemic effects is officially described as symptomatic and supportive. No specific antidote is listed in the regulatory documents. Certain procedural measures, such as gastric lavage, may be considered by medical professionals only in cases involving the ingestion of a life-threatening amount. Hospital monitoring is often required for continuous observation of potential systemic complications. No population-specific overdose considerations (e.g., for pediatrics or the elderly) are explicitly noted in the regulatory labeling.

Therapeutic Uses of Ichtholan 10%

What Ichtholan 10% Treats: Main Uses and Benefits

Ichtholan 10% is commonly used across conditions presenting with acute or episodic manifestations on the skin, where supportive symptom management is appropriate for localized irritative states. It is applied across domains where additional symptomatic support is needed for conditions presenting with systemic or localized discomfort.

The ointment is relevant for easing symptoms associated with inflammatory or irritative states, such as localized redness and swelling. By addressing these manifestations, it contributes to improved day-to-day comfort and provides supportive relief when symptoms interfere with routine activities. It also helps address symptom clusters that may become intense or disruptive, specifically targeting localized pain and itching.

It is used in areas where short-term symptom management is appropriate for conditions involving episodic or fluctuating manifestations, and may be part of symptomatic management for localized areas of tension beneath the skin, contributing to easing the overall symptom load during periods of heightened discomfort.


Quick Fact: Relief for Localized Discomfort and Inflammatory Manifestations

Regulatory References

  1. National Institutes of Health (NIH) DailyMed service

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Ichtholan 10% — Official Regulatory Information

The eligibility profile for Ichtholan 10% (Ammonium Bituminosulfonate) is determined by official governmental regulatory documents, focusing on contraindications and populations with restricted use.

Contraindicated Populations

  • Hypersensitivity: The medicine is strictly contraindicated for individuals with a known allergy or hypersensitivity to the active substance, Ammonium Bituminosulfonate, or any of the inactive ingredients (excipients) listed in the official formulation.

Age-Related Eligibility

  • Children Under 12 Years: Use is generally not established as safety and efficacy data are insufficient in this age group.
  • Adolescents and Adults: Use is allowed, provided no other contraindications are present.

Conditional and Restricted Use Populations

  • Pregnancy and Lactation: Use is not recommended and is only permitted if deemed clearly necessary by a physician, due to insufficient data. Specific restrictions apply: large-area application is contraindicated during pregnancy, and application to the breast area must not occur during breastfeeding.
  • Purulent Skin Conditions: Caution and restricted use are required in the presence of purulent (pus-containing) skin inflammations due to the risk of Schmierinfektion (smear infection/spread).

Other Considerations

  • Hepatic and Renal Impairment: No dose adjustment is considered necessary based on long-term experience.

What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Ichtholan 10%

Interaction Scope

Category Officially Documented Information
Medicinal product categories with documented interactions None Officially Documented with systemic medicines. The sole regulatory constraint relates to the localized co-application with other topical products (ointments, creams, etc.) due to chemical incompatibility.
Specific interacting medicines (if explicitly listed) None Officially Documented. No specific medicinal products are listed in official government regulatory documents as interacting substances.
Mechanistic basis of interactions (only if stated in label) None Officially Documented for systemic drugs. The localized concern is based on chemical incompatibility at the application site, which could result in precipitation or inactivation of the components.
Timing-based interaction rules (if applicable) None Officially Required for systemic medicines. A regulatory constraint requires separation of administration if other topical products are applied to the same skin area.
Population-specific interaction notes (if applicable) None Officially Documented. No specific interaction cautions are noted for populations such as those with hepatic or renal impairment.
Interaction-related restrictions Restriction against the simultaneous localized application with other topical medicinal products.

Interaction Classifications (High-Level)

Classification Officially Documented Status
Interaction severity classification (as defined in official documents) None. No systemic interactions are officially classified.
Regulatory basis (EMA / FDA / etc.) Information derived from Summary of Product Characteristics (SmPC) documents as issued by national and intergovernmental medicines authorities.
Interaction-context constraints (as defined in official documents) Interaction is constrained to the site of application; systemic interaction constraints are not documented.

Resulting Interaction Structure

Official interaction statements:

  • No interactions with other systemic medicinal products are officially documented in government regulatory sources.
  • Regulatory documents confirm that no systemic drug interactions are known for Ichtholan 10%.
  • A restriction exists regarding the simultaneous localized application with other topical medicinal preparations due to the risk of chemical incompatibility.

Connection to the overall interaction profile: The regulatory profile of Ichtholan 10% is defined by the absence of documented systemic interactions, confirming the product presents no label-based risk for drug-drug interactions involving metabolic or transporter pathways. The only official interaction constraint relates to the localized chemical incompatibility with other topical agents, which requires separation of administration if other products are to be applied to the same skin area.

Mechanism of Action

How Ichtholan 10% Works

Targeting Inflammatory Mediator Production

Ichthammol works at the cellular level by inhibiting key enzymes, such as 5-Lipoxygenase and Cyclooxygenase, within the localized arachidonic acid cascade . This action restricts the synthesis and release of potent inflammatory chemical signals like Leukotriene B4. This restriction limits the formation of potent inflammatory mediators, resulting in the attenuation of local vasodilation and the inhibition of immune cell chemotaxis at the application site.


Direct Suppression of Sensory Nerve Signals

The active substance engages in a mechanism of localized signal blockade, directly interacting with peripheral sensory nerve endings in the skin. This action effectively suppresses the transmission of afferent nerve impulses, which are involved in nociception and pruriception. The resulting interruption of nociceptive signaling produces a localized attenuation of afferent nerve impulse conduction.


Keratoplastic and Secretolytic Modulation

Ichthammol exerts a functional modulation on the epidermal structural proteins, leading to a softening and loosening effect on the outermost layer of the skin. This change in skin structure increases the permeability of the stratum corneum and follicle openings. This mechanism underlies the substance's secretolytic action, promoting the physical expulsion of confined, superficial secretions or inflammatory material.

Dosage and Administration Information

How to Use Ichtholan 10% Ointment

Ichtholan 10% is an ointment (salve) for external use on the skin. Its application follows established procedural and frequency guidelines to ensure proper usage and management of localized skin issues.


Official Administration Guidelines

The following instructions detail the standardized administration of this topical product:

Instruction Category Administration Rule
Route of Administration For topical (cutaneous) use only.
Dosing Schedule Apply a sufficient amount to cover the affected area with a thin layer of the 10% ointment.
Frequency The standard application is one to two times daily (up to three times daily in some regions).

Procedural Application Steps

The guidelines define the specific steps required for the correct application of the ointment:

  1. The affected skin area must be cleansed before the ointment is applied.
  2. Apply the required quantity of the ointment directly onto a piece of gauze bandage or plaster, rather than directly onto the skin.
  3. Affix the medicated bandage or plaster to the affected area. The ointment must not be rubbed or massaged into the skin.
  4. Wash hands thoroughly both before and after the administration procedure to maintain hygiene.

Duration and Specific Populations

Treatment should continue until the condition shows improvement. If there is no visible improvement in the skin condition, or if it worsens after a short period, a healthcare professional must be consulted. The standard application frequency for this topical agent is generally applied across Adults and Children over a specified age (e.g., 6 or 12 years).

Recent Clinical Evidence

Ichtholan 10% (Ichthammol) Research Overview

Ichtholan 10% is a topical formulation containing Ichthammol (Ammonium bituminosulfonate), a substance derived from sulfur-rich oil shale. It has a long history of use in dermatology, and recent research continues to explore its applications in various skin conditions, often leveraging its anti-inflammatory, anti-pruritic (anti-itch), and mild antiseptic properties.


Evaluation in Inflammatory Skin Conditions

Clinical experience and certain guidelines suggest the use of Ichthammol-containing products as an adjunctive treatment for conditions involving acute inflammation. This includes specific presentations of atopic eczema and dermatitis. Studies have indicated that Ichthammol may influence the processes of inflammation by inhibiting certain messenger substances in the body.

Condition Evaluated Type of Evidence Key Findings
Atopic Eczema Clinical Experience/Guidelines Considered useful addition to basic regimen, especially in mild cases.
Scalp Psoriasis Prospective Study Formulations containing Ichthammol were associated with improvements in redness, scaling, and itching scores.

Study of Topical Applications

Ichthammol's action is also frequently studied in the context of minor lesions and infections, where it is sometimes referred to as a "drawing salve." Small-scale research and case reports have explored the use of 10% Ichthammol for localized skin issues, such as abscesses and boils, noting a potential for local symptom relief and size reduction in some cases.

Safety and Event Reporting

Clinical investigations into Ichthammol have generally noted a favorable tolerability profile for topical use, both short-term and long-term. Adverse event reports are typically confined to the application site, with the most commonly noted events being mild skin irritation or a temporary burning sensation in a small subset of individuals. The substance is distinctly different from "black salves" and does not possess corrosive properties.

Key Studies & References

  1. Antiinflammatory, antibacterial and antimycotic effects of dark sulfonated shale oil (ichthammol)
  2. Boils and carbuncles: Learn More – How are boils treated?
  3. 2018 Specials Recommended by the British Association of Dermatologists for Skin Disease
  4. Ichthammol. Ichthammol drawing salve for eczema

Frequently Asked Questions (FAQ)

Common questions about Ichtholan 10% (FAQ)

Q: Can Ichtholan 10% be used on sensitive skin areas?

A: Official product information notes that local skin irritation is listed as a potential side effect. Furthermore, the medicine is contraindicated (should not be used) in individuals with a known hypersensitivity (severe allergy) to the active substance or any of the inactive ingredients. Regulatory documents state that it is contraindicated if a hypersensitivity is known.

Q: Is it normal for the skin to feel slightly warm after applying Ichtholan 10%?

A: Regulatory documents do not include slight warmth in the official product description of normal usage. However, potential adverse reactions that some users may experience, such as local skin irritation and a burning sensation, are listed in the official product information.

Q: How does the concentration of the active ingredient relate to the product's function?

A: The 10% concentration defines the established strength of Ichthammol within the ointment base. This concentration is the one determined for the product's intended actions, which include anti-inflammatory, anti-pruritic (anti-itch), and softening effects on the skin.

Q: What is the historical or traditional use of the main ingredient in Ichtholan 10%?

A: The main ingredient, Ichthammol, has a long history of use in dermatology. It is traditionally valued for its ability to help soothe localized discomfort and is associated with a functional characteristic sometimes referred to as a drawing effect on certain superficial skin issues.

Q: Is it normal to experience a slight tingling sensation after application?

A: Official product information does not include tingling in the official product description of normal usage. As a topical product, regulatory documents do list local skin irritation and a burning sensation as possible adverse effects that may occur at the application site.

Q: Can Ichtholan 10% be used in the presence of minor skin infections (informational)?

A: Ichtholan 10% is described in official documents as possessing mild antiseptic and germicidal properties. However, official safety guidance advises caution and restricted use in the presence of purulent (pus-containing) skin inflammations due to a potential risk of spreading the infection.

Q: What are the non-active ingredients or excipients in Ichtholan 10%?

A: The active substance is formulated in a lipophilic ointment base, which typically includes substances like petrolatum. Official documents state that the medicine is contraindicated if a person is sensitive to the active ingredient or any of the listed excipients (non-active ingredients).

Q: What are the key safety warnings listed in the official patient leaflet?

A: Key warnings are related to the safety profile of the topical product. These include the primary contraindication for known hypersensitivity (allergy) to any component. The preparation is strictly for external/cutaneous use only, and contact with the eyes or mucous membranes must be avoided.

Q: What information is available regarding the long-term use of Ichtholan 10%?

A: Clinical reviews have generally noted a favorable tolerability profile for both short-term and long-term use of the product. However, the risk of developing contact dermatitis (a localized skin reaction) is a safety pattern that is officially associated with prolonged use.

Q: What is the significance of the 10% concentration?

A: The 10% concentration is the officially established strength and is used to denote the exact amount of the active ingredient, Ichthammol, within the ointment. This concentration is the one indicated for its primary dermatologic purposes, such as managing localized skin inflammations.

Q: What is the consistency or texture of Ichtholan 10% ointment?

A: According to official product descriptions, Ichtholan 10% is formulated as a dark, semi-solid Ointment (salve) intended exclusively for application to the skin.

Q: What is the procedure if someone accidentally swallows Ichtholan 10%?

A: Since the product is only intended for external use, official patient information states that consulting a physician or pharmacist is the required procedure for managing cases of accidental ingestion.

Q: Are there any known interactions between Ichtholan 10% and sun exposure?

A: Regulatory documents do not list photosensitivity or any specific interaction between Ichtholan 10% and sun exposure. The product's safety profile focuses primarily on localized reactions at the application site.

How should Ichtholan 10% be stored and disposed of?

How to Store and Dispose of Ichtholan 10%

The storage and disposal of Ichtholan 10% are strictly defined by regulatory labeling to ensure product stability and environmental safety.

Official Storage Requirements

Requirement Regulatory Statement
Temperature Store not above 30 °C (often specified as 15 – 25 °C).
Container Rule The tube must be closed tightly after opening.
Protection Store in a dry place.
Stability The ointment can be used until the expiration date printed on the package.
Child Safety Keep out of the sight and reach of children.

Disposal Protocol

Official instructions prohibit discarding the medicine via wastewater or household trash. Unused or expired Ichtholan 10% should be taken to a pharmacist or an authorized collection point for proper disposal, which contributes to environmental protection.

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

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