Fongitar Shampoo

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Fongitar Shampoo

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Method of action: Antipsoriatic

Treatment option:

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Fongitar Shampoo

Fongitar Shampoo: A Medicated Dual-Action Dermatological Agent

Property Description
Active Ingredients Coal Tar, Pyrithione Zinc
Form Topical Suspension (Shampoo)
Pharmacological Class Combination Antiseborrheic and Keratolytic Agent
Route of Administration Topical
Product Type Dual-Active Formula

Fongitar Shampoo is defined as a medicated dermatological preparation formulated as a topical suspension, utilized for external application to the scalp. It is classified as a Combination Antiseborrheic and Keratolytic Agent, utilized for managing conditions characterized by accelerated skin cell shedding. This product's identity is rooted in its therapeutic function, distinguishing it from non-medicated cosmetic cleansers by the intentional inclusion of Active Pharmaceutical Ingredients (APIs) intended to stabilize the scalp’s epidermal and microbial environment.


Composition: The Combination of Coal Tar and Pyrithione Zinc

The shampoo's therapeutic activity is derived from its two key ingredients: Coal Tar and Pyrithione Zinc. Coal Tar, a complex derived substance, functions primarily as a cytostatic and keratolytic component, working to normalize the cell life cycle and soften scaly skin. Pyrithione Zinc, a synthetic coordination complex, provides the antifungal and antiseborrheic component, acting to control the proliferation of yeasts like Malassezia species often implicated in scalp inflammation. This dual-active formula is a differentiating factor, as it targets both the cellular overgrowth and the microbial imbalance concurrently.


General Therapeutic Purpose and Scalp Stabilization

The general purpose of this medicine is scalp stabilization, achieved by implementing two complementary actions: slowing excessive skin cell proliferation and managing microbial overgrowth. Pyrithione Zinc’s fungistatic properties interfere with the growth of targeted microorganisms, and the keratolytic activity of Coal Tar aids in reducing the rapid shedding of skin cells. The primary benefit is the reduction of visible scaling and relief from persistent pruritus (itching) associated with inflammatory scalp conditions, helping to restore a healthier epidermal environment. For individuals managing recurring scalp discomfort, this combination formula is a trusted option within topical dermatological care.

What side effects are possible with Fongitar Shampoo?

Possible Side Effects and Safety Information

The safety profile of Fongitar Shampoo (containing ketoconazole) is defined by officially documented adverse reactions, which are primarily local and affect the application site, hair, and scalp.

Adverse Reactions

Adverse drug reactions (ADRs) observed in clinical trials occurred in less than 1% of patients and are generally classified as Uncommon (ge 1/1,000 to < 1/100 incidence). The official safety data identifies the following adverse reaction categories:

System Organ Class Uncommon ADRs Rare/Post-Marketing ADRs (Frequency Not Known)
Skin and Subcutaneous Tissue Disorders Alopecia, Dry skin, Hair texture abnormal, Rash, Skin burning sensation Angioedema, Urticaria, Hair colour changes, Acne, Contact dermatitis, Skin exfoliation
General Disorders & Admin Site Conditions Application site erythema, irritation, pruritus, or reaction Application site hypersensitivity, Application site pustules
Other Folliculitis, Increased lacrimation, Dysgeusia (taste disturbance) Hypersensitivity, Eye irritation

Serious Reactions: The potential for serious hypersensitivity reactions, including Angioedema (swelling beneath the skin) and Urticaria (hives), has been reported through post-marketing experience. These are classified with a frequency of Not Known (cannot be estimated from available data) and represent the most clinically significant documented safety concern.

Safety-Related Restrictions

  • Contraindications: The shampoo is strictly contraindicated for individuals with known hypersensitivity or allergy to the active substance (ketoconazole) or any of the excipients in the formulation.
  • Eye Contact: Contact with the eyes must be avoided, as the product can be irritating to mucous membranes. If accidental contact occurs, the eyes should be bathed gently with water.
  • Corticosteroid Use: Patients on prolonged topical corticosteroid treatment should gradually withdraw the steroid therapy over a 2–3 week period while using the shampoo to mitigate a potential rebound effect.
  • Specific Populations: Safety and efficacy have not been established in children younger than 12 years of age. For pregnant or lactating women, caution is advised as there are no adequate and well-controlled studies, although systemic absorption of the topical shampoo is considered minimal.

Overdose and Emergency Response

The official regulatory documentation for the active ingredients in Fongitar Shampoo (Coal Tar and Pyrithione Zinc) defines overdose primarily in the context of accidental ingestion of the topical liquid, rather than systemic toxicity from excessive skin application.

Feature Regulatory Documentation Status
Primary Overdose Concern Accidental swallowing of the topical suspension.
Documented Manifestations Specific systemic signs are not itemized; the event is classified as one with the potential for systemic poisoning [Government Regulatory Basis].
Population Risk The mandatory warning Keep out of reach of children designates them as a high-risk group for accidental ingestion.

The required emergency actions are clear and non-negotiable when ingestion occurs. In this circumstance, the regulatory instruction is to Seek immediate medical attention or Contact a Poison Control Center right away. These mandated actions are necessary to assess and manage the potential for acute, systemic toxicity. No specific antidote is documented or specified in the official product labeling; therefore, clinical management relies on supportive and symptomatic treatment provided in a professionally monitored setting. The focus of the official overdose profile is strictly on the immediate need for emergency care following an exposure event.

Therapeutic Uses of Fongitar Shampoo

The primary therapeutic support is considered relevant in clinical settings marked by the heightened symptoms of chronic inflammatory scalp conditions. Its ingredients are commonly used to help with the control of conditions involving localized discomfort and inflammatory processes, specifically dandruff, seborrheic dermatitis, and scalp psoriasis.

This preparation is relevant in contexts involving heightened systemic burden where supportive symptom management is appropriate. It is applicable in situations involving recurrent or episodic manifestations, assisting with the management of pronounced discomfort, including recurring and intense scalp itching (pruritus) and localized irritation.

Fongitar Shampoo helps address the visible burden of excessive scaling, flaking, and associated crust formation. This approach generally helps improve day-to-day comfort during periods of heightened symptoms, may assist patients with managing difficult episodes, and contributes to easing the overall symptom load.


Key Symptom Focus: Supports management of persistent scaling and itching.

Eligibility and Restrictions for Use

Who Can and Cannot Use Fongitar Shampoo? (Official Eligibility)

This section outlines the official population eligibility and contraindications for Fongitar Shampoo, based strictly on government regulatory documents.


Contraindications: Who Must Not Use It

Use of Fongitar Shampoo is absolutely contraindicated (must not be used) if an individual has:

  • A known hypersensitivity or allergy to the active ingredient, ketoconazole, or any of the product's other components.
  • Broken or inflamed skin on the scalp or application area.

Age-Related Eligibility

Population Regulatory Status
Adults and Adolescents (typically 12 years and older) Use is established and generally allowed.
Children (under 12 years) Safety and effectiveness have not been established. Use is generally not recommended.

Special Population Limitations

Population Regulatory Caution
Pregnant Women Use is conditional. Should be used only if the potential benefit justifies the potential risk, as determined by a healthcare provider.
Nursing/Breastfeeding Women Use requires caution, although systemic absorption from topical scalp application is typically undetectable.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Category Official Regulatory Documentation
Medicinal product categories with documented interactions Photosensitizing medicinal products (systemic or topical agents that increase light sensitivity)
Specific interacting medicines (if explicitly listed) Not consistently listed across all regulatory documents; examples cited in related guidance include Methoxsalen or Aminolevulinic acid when used in combination with UV radiation exposure.
Mechanistic basis of interactions (only if stated in label) Pharmacodynamic photosensitization (increased risk of phototoxicity or severe local reaction upon co-exposure to UV light).
Timing-based interaction rules (if applicable) The treated area must be protected from direct sunlight or artificial UV light sources for a specified period (e.g., up to 72 hours) following application.
Population-specific interaction notes (if applicable) None documented. Regulatory labels do not contain explicit statements altering the interaction profile for specific populations.
Interaction-related restrictions Exposure to Ultraviolet (UV) light (including direct sunlight, sunlamps, or phototherapy) is restricted following application.

Interaction Classifications (High-Level)

Category Official Regulatory Documentation
Interaction severity classification The interaction with UV light is considered clinically significant, classified by some sources as leading to a severe phototoxic reaction.
Regulatory basis Information is aligned with FDA Over-the-Counter (OTC) Drug Monograph principles and labeling standards regarding topical agent photosensitivity warnings.

Official interaction statements:

  • The Coal Tar component is officially documented as conferring a photosensitizing effect on the skin of the treated area.
  • The interaction necessitates a mandatory, time-dependent separation requirement from both natural and artificial Ultraviolet (UV) light sources.
  • Co-administration with other photosensitizing medicinal products is subject to regulatory caution due to the risk of additive phototoxicity when followed by UV light exposure.
  • Regulatory documentation reflects the absence of systemic pharmacokinetic interactions (e.g., CYP-mediated or transporter-based effects), consistent with the minimal systemic absorption from the topical route of administration.

Connection to the overall interaction profile (2–4 sentences): Regulatory documents define this product's interaction profile almost exclusively around a single pharmacodynamic constraint: the risk of phototoxicity caused by the Coal Tar component upon co-exposure to UV radiation. This profile mandates a timing restriction and imposes restrictions on combining the product with other photosensitizing agents to prevent a severe local reaction. The official labeling, reflecting the topical route, otherwise documents an absence of systemic pharmacokinetic interactions.

Mechanism of Action

The mechanism of this topical suspension relies on the complementary action of two active components, Pyrithione Zinc and Coal Tar, to modulate distinct biological pathways.


Inhibiting Microbial Proliferation

The primary mechanistic domain of Pyrithione Zinc involves fungistatic activity against Malassezia species. It acts as an ionophore, facilitating the influx of metal ions that damage and inactivate critical mitochondrial enzymes within the fungal cell. This molecular action suppresses fungal growth and limits the production of free fatty acids, decreasing the microbial-driven inflammatory load on the epidermis.


Normalizing Epidermal Cell Turnover

The parallel domain of action, driven by Coal Tar, is both cytostatic and keratolytic. Coal Tar works by interfering with DNA synthesis in hyperproliferating keratinocytes, effectively slowing the rate of cell division in the epidermis. This normalization of epidermal cell kinetics, coupled with the disruption of intercellular cohesion, supports a more regulated epidermal state and leads to a reduced rate of cellular accumulation in the outer epidermal layers.


Physiological Consequences of Dual Action

These two mechanisms result in coordinated physiological changes: microbial control is achieved while simultaneously modulating the hyperproliferative cellular response. This dual-target modulation impacts both microbial activity and keratinocyte kinetics, leading to a modified inflammatory and proliferative state of the scalp epidermis.

Dosage and Administration Information

The administration of Fongitar Shampoo is governed by usage protocols established for medicated topical suspensions containing Coal Tar and Pyrithione Zinc. The preparation is designated strictly for topical application to the scalp.

Official Administration Guidelines

The core principles of administration relate to frequency and the required application technique, ensuring proper contact time with the active ingredients.

Feature Official Labeled Guideline
Route Topical application to the scalp only.
Dosing Frequency Use a minimum of twice weekly to manage symptoms, or increase application to every time the hair is shampooed for maximum control.
Preparation The topical suspension must be shaken well immediately before each use to ensure uniform concentration of the ingredients.
Contact Time The application process requires the lather to be left on the scalp for several minutes before rinsing.
Age Rule Use in children under 2 years of age must be determined by a physician, as stated in official labeling.

Procedural Structure

The standard administration involves a two-step sequence. First, the product is applied to the wet scalp and massaged into a lather. After the specified contact time, the product is rinsed thoroughly, and the entire application is repeated. If an application is missed, the dose should be resumed when remembered, but double doses should not be applied to compensate for the skipped use. These instructions define the standardized approach to using the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Fongitar Shampoo

The evidence base for the active ingredients in Fongitar Shampoo—Coal Tar and Pyrithione Zinc—is compiled from structured clinical evaluations and the evidence documented by regulatory bodies. This overview describes the research landscape.


Evidence for use in Dandruff (Pityriasis capitis)

Research relies on Randomized Controlled Trials (RCTs) and comparative studies. Study designs were used in research exploring how symptoms change over time, monitoring visible scaling, flaking, and patient-reported outcomes describing perceived discomfort (itching). Findings describe patterns of change compared to non-active formulations in the observed populations.


Evidence for use in Seborrheic Dermatitis (Scalp SD)

The evidence for this condition includes RCTs and Systematic Reviews. Studies monitored outcomes linked to inflammatory states, examining measurements related to scaling, erythema (redness), and perceived discomfort over defined time intervals. Results apply mainly to adult populations with mild-to-moderate disease.


Evidence for use in Scalp Psoriasis

Research for this indication is based on evidence reviewed for Regulatory Monographs and supportive post-marketing data. Studies monitored outcomes related to physical discomfort, focusing on measurements of scaling thickness and perceived discomfort. The existing data is largely defined by the established regulatory status of the Coal Tar ingredient in isolation.


Long-Term Studies and Follow-Up Data

Most clinical trials assessed outcomes during short-term (4–6 weeks) or intermediate-term (up to 12 weeks) use. Long-term effects are not fully established regarding the durability of response after treatment stops, and limited information is available for symptom recurrence prevention.


Evidence in Specific Patient Groups

The research was primarily applied in studies examining adult populations with mild-to-moderate disease. Data for certain groups remain insufficient, including individuals with severe disease or specific comorbidities.


What is Still Uncertain About the Research

Comparative evidence against all alternative treatments is lacking. Furthermore, follow-up durations were limited, and overall, findings describe group patterns, not personal outcomes.

Key Studies & References Anti-Dandruff Products Monograph (Health Canada)

Frequently Asked Questions (FAQ)

Common questions about Fongitar Shampoo (FAQ)

Q: How quickly can I expect to see the effects of Fongitar Shampoo?

A: Official guidelines indicate that achieving the full intended effect requires consistent and regular use. Effectiveness is typically measured based on using the product as directed over a period of several weeks. Consistent use, according to the label's directions, is considered necessary for the product's full intended effect.

Q: Can Fongitar Shampoo be used on colored or treated hair?

A: Official product warnings related to the Coal Tar component advise that the shampoo may rarely cause changes to hair color, particularly in light-colored hair. The product also carries a caution that it may stain hair or skin. These warnings describe a potential risk for individuals with cosmetically treated hair.

Q: Does Fongitar Shampoo interact with any common over-the-counter medications?

A: Regulatory documents reflect that because the product is applied topically, minimal systemic absorption occurs. Therefore, it is generally not expected to interact with common orally-taken systemic medicines, such as those for pain relief. Official warnings primarily focus on the risk of interaction with other topical agents or photosensitizing medicines.

Q: Is there a limit to how long a person can continue using Fongitar Shampoo?

A: Official instructions caution against using the product for a longer duration than what is recommended on the label. Regulatory documents note that prolonged use beyond label directions warrants consultation with a healthcare provider. There is no specific, open-ended time limit for continuous use provided in regulatory documents.

Q: Why do some people experience initial irritation when starting Fongitar Shampoo?

A: The official safety profile for the active ingredients lists skin irritation, stinging, and a burning sensation as common reactions that may occur at the application site. These temporary effects are considered part of the product's known side effect profile, which is associated with its intended action on the scalp.

Q: Is Fongitar Shampoo generally available without a prescription?

A: The product's active ingredients, at the labeled concentrations, are categorized by regulatory agencies as Over-the-Counter (OTC) drug products. This classification is governed by an official FDA Monograph, allowing it to be sold without a prescription.

Q: Do regulatory agencies classify Fongitar Shampoo as generally safe?

A: The active components of the shampoo are included in the FDA's OTC Monograph. This classification indicates that the ingredients are generally recognized by regulatory bodies as safe and effective for their intended therapeutic use when the product is applied according to its directions.

Q: Can Fongitar Shampoo be used with other medicated hair products?

A: Official regulatory warnings advise caution when using Fongitar Shampoo with any other topical products, especially those that are also medicated. Combining the shampoo with photosensitizing medicines or certain other treatments is restricted. The official warnings indicate that co-application of other medicated hair products warrants guidance.

Q: Do studies suggest Fongitar Shampoo is effective for severe scalp flaking?

A: The research studies cited in official literature primarily examine populations with mild-to-moderate symptoms. For individuals who have severe or persistent scalp flaking, the scope of research may be limited. If the condition does not show improvement, official guidance indicates that consultation with a healthcare provider is appropriate.

Q: Is the sensation of tingling common after applying Fongitar Shampoo?

A: The safety profile lists temporary local sensory effects as possible adverse reactions. These reactions include stinging, burning, or irritation at the application site. Tingling is considered comparable to these common and temporary local sensory effects.

Q: What evidence is there regarding the continued use of Fongitar Shampoo for maintenance?

A: Official product information supports the principle that continued, regular use is helpful for maintaining the described benefits. Regular application is intended to help prevent the recurrence of flaking and itching associated with scalp conditions.

Q: Can men and women use Fongitar Shampoo in the same way?

A: Regulatory documents and the official product instructions provide a single set of dosage and administration guidelines. These guidelines are generic and do not differentiate the required use pattern based on adult gender.

Q: Can using Fongitar Shampoo affect drug test results?

A: Official product warnings indicate that the active ingredient may interact with certain laboratory tests. Official warnings state that it is necessary to inform laboratory personnel and healthcare providers of the product's use, as this interaction could potentially cause false results.

Q: Does the packaging of Fongitar Shampoo indicate any major allergen information?

A: Federal labeling regulations require that the product lists all inactive ingredients on the packaging. This is mandated so individuals may review the contents for any known allergens. The official contraindications also state that the product must be avoided if there is an allergy to any ingredient.

Q: Does Fongitar Shampoo help with oily scalp?

A: The official labeling states that the active ingredient Pyrithione Zinc is included in the formulation for its role in managing oiliness that may be associated with dandruff and seborrheic dermatitis. This ingredient targets the oiliness that can contribute to inflammatory scalp conditions.

Q: Are there different strengths or formulations of Fongitar Shampoo available?

A: Regulatory documents covering the active ingredients indicate that a range of concentrations and various dosage forms exist for this product class. The specific availability of different strengths or formulations of Fongitar Shampoo depends on the manufacturer's offerings and local market regulation.

Q: Does Fongitar Shampoo contain any parabens or sulfates?

A: Official drug labels are mandated to list all inactive ingredients. Reviewing this list allows individuals to determine the presence of ingredients used for cleaning and formulation purposes, such as sulfates or other common excipients. Contraindications require avoidance if an allergy to any ingredient is known.

How should Fongitar Shampoo be stored and disposed of?

How to Store and Dispose of Fongitar Shampoo?

The storage and disposal of Fongitar Shampoo (Coal Tar and Pyrithione Zinc) must adhere strictly to official regulatory guidelines to maintain product stability and ensure public safety.


Storage Requirements

Condition Requirement
Temperature Store at Controlled Room Temperature, typically 20 C to 25 C.
Protection Protect from light and do not freeze the product.
Container Keep in the original container with the cap tightly closed.
Child Safety Store out of the sight and reach of children.

️ Disposal Instructions

Unused or expired medicated shampoo should not be disposed of via wastewater or household trash. Instead, follow local instructions by asking a pharmacist or utilizing an official drug take-back program to ensure the medicine is discarded safely and prevents environmental contamination.

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

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