Ichthyol ointment

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Ichthyol ointment

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Medically reviewed

Rosario Oropesa

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 Ichthyol ointment

Property Description
Active ingredient Ichthammol (Ammonium bituminosulfonate)
Form Ointment, Cream, Lotion (Topical)
Pharmacological class Dermatologic Agent, Antiseptic, Anti-inflammatory agent
Common use Soothing localized skin irritations (Drawing Salve)
Origin Derived from natural mineral (sulfonated shale oil)

Defining Ichthyol Ointment: Active Ingredient and Class

Ichthyol Ointment is a well-established topical dermatologic preparation defined by its core active ingredient, Ichthammol, which is officially known in pharmacopeias as Ammonium bituminosulfonate. Within pharmacology, Ichthammol is broadly categorized as an Antiseptic and an Anti-inflammatory agent. The preparation is primarily available in the dosage form of an ointment or cream and is intended for topical (cutaneous) administration. It is occasionally referenced by the traditional, non-official name, "Black Ointment." This classification confirms the medicine as a recognized single-entity compound designed for external application.


Ichthammol: Composition, Origin, and Properties

The active substance Ichthammol is a unique complex chemical entity whose preparation is derived from natural mineral sources—specifically, the destructive distillation and subsequent sulfonation of bituminous schists (shale oil). This mineral-derived origin sets it apart from purely synthetic topical treatments. The defining attribute of Ichthammol is its substantial content of organically bound sulfur, which is considered fundamental to its therapeutic actions. The ingredient possesses mild antiseptic and anti-inflammatory properties, making it useful in various skin conditions. The final formulation consists solely of Ichthammol combined with a fatty base/vehicle, such as petrolatum or lanolin.


General Therapeutic Role: Why is it Used?

Its general function is as a supportive agent for localized skin irritations. Its role is based on its multiple properties: it is used to moderate localized inflammation and swelling, and to provide a mild antiseptic effect on the skin's surface. Ichthammol functions by reducing the release of inflammatory mediators in the skin, which underlies its anti-pruritic effects. It is often utilized in situations involving localized superficial irritation where a mild drawing action is desired, such as helping to soothe small areas of skin that are tender and contained.

Regulatory References

  1. Ichthammol Drug Label Information

What side effects are possible with Ichthyol ointment?

Possible side effects and safety information

Official regulatory documents classify the safety profile of Ichthammol Ointment (Ammonium bituminosulfonate) as primarily involving localized cutaneous reactions, consistent with its topical application as a dermatologic agent.


Documented Adverse Reactions

Adverse reactions are classified within the Skin and subcutaneous tissue disorders and the Immune system disorders System-Organ Classes.

Classification Adverse Reaction Context
Common / Expected Local skin irritation, Erythema (redness), Pruritus (itching), Dry skin, Burning sensation (transient) Effects localized to the application site.
Uncommon Allergic skin reactions (Contact dermatitis) Officially documented frequency based on regulatory data.

Safety Constraints and Considerations

The most important safety information relates to the proper application context, which is essential to prevent severe local effects or increased absorption. Regulatory labeling strictly dictates that the ointment is for external use only [DailyMed]. Application must be avoided on large areas of broken skin, mucous membranes, or the eyes, as this could lead to heightened irritation or potential systemic exposure.

Time-Related Patterns

A burning sensation or erythema may be more noticeable upon the initial applications of the product. The risk of developing allergic contact dermatitis may be associated with prolonged or repeated use over time.

Population Considerations

Regulatory agencies advise caution or consultation for use during pregnancy and breastfeeding due to the absence of extensive data regarding systemic absorption, aligning with standard regulatory practice for many topical products. Individuals with a known hypersensitivity to the active ingredient must avoid use.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Ichthyol ointment (Ammonium Bituminosulfonate) primarily addresses the management of accidental systemic exposure and local adverse effects from excessive use.

Accidental Ingestion and Emergency Action

The most significant overdose risk detailed in regulatory documents is accidental ingestion of the product, which is particularly relevant for children.

Overdose Scenario Required Emergency Action
If the product is swallowed Get medical help or contact a Poison Control Center immediately.
Local symptoms persist Stop use and ask a doctor if redness, irritation, swelling, or pain persists after application.

Accidental ingestion is designated as an event requiring immediate professional intervention, and the product must be kept out of reach of children to mitigate this risk. No specific antidote for Ichthyol overdose is specified in the official labeling.

Documented Overdose Manifestations

No specific systemic toxicity symptoms are explicitly listed as characteristic of Ichthyol ointment overdose in regulatory labeling. However, excessive topical application that results in persistent or severe adverse reactions such as skin irritation, pain, or swelling is the documented local consequence that requires medical consultation. Management for systemic exposure is symptomatic and supportive, as determined by a healthcare professional.

Therapeutic Uses of Ichthyol ointment

What Ichthyol Ointment Treats: Main Uses and Benefits

Ichthyol Ointment is used to provide symptomatic support for various localized skin issues. This topical preparation is commonly used across conditions presenting with acute or episodic changes, helping to address symptom clusters related to heightened physiological activity.

It is generally applied in contexts involving symptomatic discomfort such as mild eczema, dermatitis, furuncles (boils), and minor abscesses, as well as common irritations like insect bites and ingrown hairs. The application helps manage symptoms that interfere with daily comfort, including redness, localized swelling, and pruritus (itching). The application is also relevant for its effect on contained lesions, supporting patients during episodes of heightened discomfort associated with these manifestations.

Quick Fact: Symptomatic Relief Ichthyol Ointment is used in clinical contexts involving common, external irritations to support patients during episodes of heightened discomfort by easing symptom burden.

Regulatory References

  1. NIH DailyMed overview of Ichthammol Ointment uses

Eligibility and Restrictions for Use

Ichthyol ointment is approved for use across various age groups, though specific restrictions define who is eligible and who must avoid the medicine according to official regulatory labeling.


Eligibility Scope

  • Populations for whom use is allowed: Use is established for the general adult population, older adults, and the pediatric population (specifically, children under 12 years).
  • Populations for whom use is contraindicated: Use is strictly contraindicated in individuals with a known hypersensitivity or documented allergy to the active ingredient, Ichthammol, or any of the ointment’s excipients.
  • Age-related eligibility rules: Established use covers adults, older adults, and children under 12 years.

Conditional and Restricted Use

  • Pregnancy and Lactation Eligibility: The regulatory status for pregnant and breastfeeding individuals is that use has not been formally investigated. Due to this insufficient data, the product is subject to conditional recommendation.
  • Eligibility-related restrictions: Application is prohibited on broken skin and on mucous membranes (such as the eyes, nose, or mouth), as these conditions represent absolute bars to the product's use.
  • Condition-specific eligibility: Official labeling generally does not include explicit contraindications for systemic conditions like hepatic or renal impairment for topical Ichthammol.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for topical Ichthyol Ointment (Ichthammol or Ammonium bituminosulfonate) is defined by the absence of formally documented systemic interactions. This determination is made based on the medicine’s topical route of administration and the minimal rate of absorption of its active component into the systemic circulation.

Official Interaction Scope

Interaction Type Regulatory Documentation Status
Systemic Drug-Drug Interactions None formally documented.
Pharmacokinetic Interactions (CYP, Transporters) None formally documented.
Contraindicated Combinations None formally documented.
Alcohol, Food, or Herbal Products No known interactions are documented.

Regulatory Conclusion

Official government prescribing information, including documentation from regulatory agencies, establishes that neither specific medicinal products nor general product classes are listed as interacting with Ichthyol Ointment. Due to its minimal systemic presence, the official labeling for this preparation does not include mandatory timing-based separation rules or specific population-based interaction cautions, such as those related to kidney or liver function. This means the official prescribing text does not contain specific restrictions on the co-administration of Ichthyol Ointment with other systemic medications. The resulting interaction profile is a neutral reflection of the medicine’s highly localized action, which results in a negligible risk of systemic interaction as determined by regulatory authorities.

Mechanism of Action

Modulating Local Inflammatory Signaling

The mechanism of Ichthammol (Ammonium bituminosulfonate) primarily engages in the enzyme-mediated signaling pathways characteristic of inflammation. It acts as an inhibitor of key enzymes, specifically Cyclooxygenase (COX) and Lipoxygenase (LOX), within the Arachidonic Acid Cascade. This molecular action modifies the initial synthetic steps of potent inflammatory mediators, leading to the attenuation of the inflammatory cascade and reducing capillary permeability, which results in decreased tissue exudation.

Dual Mechanism for Dermal Structure and Signal Interference

Ichthammol's core mechanism involves localized physiological adjustments through two complementary actions. First, its sulfur compounds disrupt the metabolic processes and cell membrane integrity of certain microorganisms, resulting in a bacteriostatic and fungistatic action. Second, the drug possesses keratoplastic and osmotic properties that loosen the stratum corneum (outer skin layer), increasing dermal permeability and modulating dermal cohesion. Concurrently, the compound exerts a peripheral effect by inhibiting signals transmitted via sensory nerve fibers, resulting in the suppression of nociceptive signaling and afferent C-fiber activity.

Dosage and Administration Information

The administration of Ichthyol Ointment is based on a localized topical protocol, which defines the method, quantity, and frequency of application. The preparation, commonly available in 10% or 20% strengths of the active ingredient, Ichthammol, is strictly for external use.

Official Administration Guidelines

The usage protocol is based on specific instructions to ensure the ointment is applied correctly. The route of administration is consistently topical (cutaneous use).

Administration Scope General Instruction
Dosage Quantity Apply an amount sufficient to form a thin layer over the affected area.
Dosing Frequency Apply to the affected area once or twice a day. The application may be repeated as necessary for episodic use.
Age Restriction Directions are generally specified for use in adults and children 6 years and over.

Procedural Instructions

Correct application involves specific preparation and handling steps:

  1. The skin area requiring treatment must be cleansed prior to the ointment’s application.
  2. Apply the thin layer of the ointment and cover the treated area, typically with a gauze bandage or a loose wrapping.
  3. Do not rub or massage the preparation into the affected area.

These parameters define the usage pattern as a non-systemic, localized treatment, structuring how the medicine is used in practice.

Recent Clinical Evidence

Evidence for Use in Localized Inflammatory Skin Conditions (Eczema, Dermatitis)

Research has explored the use of the ointment for conditions characterized by fluctuating or episodic manifestations like eczema and dermatitis. Studies have included short-term Randomized Controlled Trials (RCTs), systematic literature reviews, and mechanistic laboratory analyses. These trials primarily explored outcomes related to physical discomfort in patient populations, including pediatric patients (children).

In these research settings, studies monitored outcomes related to physical discomfort, such as disease severity index scores and the patients' reported experience of pruritus (itching). Some controlled trials reported that patterns in the measured outcomes were mixed when compared against a non-active base or vehicle cream. Overall, the available research base for this application evidence is limited and heterogeneous.

Evidence for Use in Localized Lesions and Superficial Irritations (Furuncles, Minor Abscesses)

Research was studied for conditions associated with acute or disruptive episodes, with evidence largely supported by case series and descriptive historical reports, supplemented by laboratory studies. Specific studies examined the use of the ointment on contained skin lesions. In these settings, studies examined adult populations presenting with episodic or acute changes.

Studies reported how symptoms evolved in the observed populations, monitoring outcomes related to physical discomfort and describing the duration of phases of heightened symptom activity. This body of evidence is highly heterogeneous and mainly relies on descriptive reporting, as modern, controlled clinical trials are lacking for these specific acute uses. The evidence for this application is not supported by the same level of controlled trials that is often available for modern treatments.

Long-Term Studies and Follow-up Duration

The existing evidence base primarily consists of trials and observational periods with follow-up durations that were limited to the short term. This means that long-term outcomes are not well characterized and research exploring patterns of response over time or continued use remains insufficient in the current scientific literature.

Key Studies & References

  1. Ichthammol Ointment 20% - DailyMed (Human OTC Drug Label)
  2. Efficacy and tolerability of pale sulfonated shale oil cream 4% in the treatment of mild to moderate atopic eczema in children: a multicentre, randomized vehicle-controlled trial
  3. Ichthammol revisited (Review of historical and dermatologic applications)
  4. [Anti-inflammatory, antibacterial and antimycotic effects of dark sulfonated shale oil (ichthammol)]

Frequently Asked Questions (FAQ)

Common questions about Ichthyol ointment (FAQ)

Q: Is Ichthyol ointment the same as the corrosive product often called 'black salve'?

Official documents define Ichthyol ointment as a sulfonated shale oil derivative used as a mild antiseptic and anti-inflammatory agent for dermatologic application. This preparation is not the same as 'black salve,' which often contains corrosive ingredients and is subject to official warnings from regulatory agencies.


Q: Is the distinctive odor of Ichthyol ointment considered a normal characteristic?

Yes, the distinctive odor is a normal characteristic. The active ingredient, Ichthammol, is derived from bituminous schists (shale oil). Official monographs describe the substance as having a characteristic, bitumen-like odor, which is an expected and inherent property of the preparation.


Q: What is the official advice if skin irritation or redness occurs or worsens after using the ointment?

Regulatory documents list localized skin irritation and redness (erythema) as possible effects. Official safety instructions advise discontinuation if skin reactions persist or worsen. Official safety documents indicate that advice from a qualified healthcare professional may be appropriate in these circumstances.


Q: Does Ichthyol ointment affect the absorption of other topical products applied simultaneously?

Official drug labeling does not formally document any systemic interactions due to the minimal rate of absorption. However, the product possesses keratoplastic and osmotic properties, which soften the outer skin layer. This mechanism may be relevant to the absorption of other topical preparations applied at the same location.


Q: What information is available regarding the use of Ichthyol ointment during pregnancy?

Regulatory documents state that the use of Ichthyol ointment has not been formally investigated in pregnant individuals. Due to this lack of extensive data on systemic absorption, the product is subject to conditional guidance regarding use during pregnancy, consistent with regulatory practice for many topical agents.


Q: Are there any specific warnings about using Ichthyol ointment while breastfeeding?

Official regulatory documents indicate that the use of Ichthyol ointment has not been formally investigated while breastfeeding. Due to the absence of extensive safety data, the product is subject to conditional guidance regarding use by individuals who are breastfeeding.


Q: Is the effect of Ichthyol ointment described in official sources as 'drawing' or softening the skin?

Official texts describe the ointment as possessing keratoplastic and osmotic properties, which soften the outer skin layer and aid drainage. The product is sometimes associated with a mild 'drawing action,' which relates to its effects of softening the outer skin layer and modulating dermal cohesion.


Q: Does Ichthyol ointment contain Lanolin, and is there an allergy warning for this ingredient?

Ichthyol ointment often contains excipients (inactive ingredients) such as Lanolin or Petrolatum in its base. Regulatory safety information indicates that use should be avoided in cases of known hypersensitivity or documented allergy to the active ingredient or any of the excipients.


Q: Are there any age-related restrictions on use for older adults?

Regulatory information establishes use for the general adult population, which includes older adults. Official documents do not list specific additional precautions or contraindications solely based on older age compared to other adults.


Q: What is the official guidance on how often Ichthyol ointment should be applied?

The official product information typically specifies a frequency of application of once or twice a day. The product’s application may also be repeated as necessary for episodic use.


Q: What is the origin of the raw material used to produce Ichthammol?

The active substance, Ichthammol, is described in pharmacopeias as being derived from natural mineral sources. Specifically, it is produced through the destructive distillation and subsequent sulfonation of bituminous schists, which is a type of shale oil.


Q: Is the black or dark color of the ointment expected to stain the skin permanently?

Due to its characteristic dark color, the product can stain the skin and other materials upon contact. While the color is intense, permanent staining of the skin itself is not commonly documented, but temporary discoloration at the application site is possible.


Q: Can the ointment cause permanent staining of clothing or bedding materials?

Yes, official information acknowledges the risk of staining clothing and bedding due to the dark color and oily texture of the ointment. Covering the treated area with a bandage or gauze is often advised as a precautionary measure to minimize this risk.


Q: What is the appropriate way to remove the ointment from the skin before a fresh application?

The usage protocol requires the skin area to be cleansed prior to application. Due to its oil-based nature, patient-facing instructions commonly suggest using a mild soap and warm water, or a gentle oil-based cleanser, to facilitate its complete removal.


Q: Is it recommended to cover the treated area with a bandage after applying the ointment?

The official application procedure frequently instructs patients to cover the treated area, typically with a gauze bandage or loose wrapping, after applying a thin layer of the ointment. This step helps to keep the product in place and protects clothing from staining.


Q: What research evidence themes exist regarding the use of Ichthyol ointment for acne?

Pharmacological monographs and specialist association lists often mention the use of Ichthammol for various localized inflammatory skin conditions. This includes research examining the product in the context of acne.


Q: Is it described as normal for the treated area to feel warm after application?

Official documents list a transient burning sensation as a possible, common side effect upon initial application. Patient-facing documents sometimes describe this sensation in milder terms, such as a localized feeling of warmth.


Q: What is the appropriate procedure for disposing of unused or expired Ichthyol ointment?

Official instructions mandate that unused or expired ointment be properly discarded according to local/regional regulations, and it should not be flushed down the toilet. General guidance from government agencies for disposal often involves mixing the medication with an unpalatable substance (like dirt or coffee grounds), placing it in a sealed bag, and disposing of it in household trash.

How should Ichthyol ointment be stored and disposed of?

The storage and disposal of Ichthyol (Ichthammol) Ointment must comply strictly with official regulatory labeling to ensure product stability and safety.

Storage Conditions

  • Temperature: Store at room temperature, typically defined as 15 C to 30 C (59 F to 86 F).
  • Container: Keep the product in the original container and the cap tightly closed when not in use.
  • Child Safety: It is mandatory to keep out of reach of children and seek immediate medical help or contact a Poison Control Center if the product is swallowed.

Disposal Instructions

  • Mandate: Unused or expired ointment must be properly discarded according to local/regional regulations.
  • Restriction: Do not flush the medicine down the toilet or pour it into a drain unless specific instructions from a regulated disposal program are provided.

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

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