Kamillosan

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Medically reviewed

Marina Burgos

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 Kamillosan

Quick Facts

Property Description
Active Ingredients Levomenol (Natural Alpha-bisabolol), Chamazulene
Primary Form Liquid Extract/Solution (Concentrate)
Pharmacological Class Traditional Herbal Anti-inflammatory and Antiseptic Agent
Origin Plant-based (Matricaria Chamomilla)
General Purpose Soothing and mitigating superficial irritation

Defining Kamillosan: A Traditional Herbal Medicinal Product

Kamillosan is a well-established traditional herbal medicinal product founded upon the beneficial properties of German Chamomile (Matricaria Chamomilla). The preparation is broadly classified as an anti-inflammatory and antiseptic agent due to its recognized topical effects.

The product's identity is defined by its plant-based origin and is available in multiple high-level pharmaceutical forms, including a concentrated liquid extract/solution, cream, and ointment. Preparations of Matricaria chamomilla are traditionally used for symptomatic relief of minor inflammation of the mouth and throat. This recognition emphasizes the product's function in helping to ease discomfort and superficial inflammation.

Composition and Active Constituents (Levomenol and Chamazulene)

The efficacy of Kamillosan relies on a combination of active components extracted from the chamomile flower, specifically standardized extracts containing Levomenol (Natural Alpha-bisabolol) and Chamazulene. Levomenol, a monocyclic sesquiterpene alcohol, is recognized for its chief soothing and calming effect.

A distinguishing feature of the product is its use of a specific, high-yield strain of Matricaria Chamomilla, intended to ensure a consistent, higher content of Levomenol compared to generic extracts. This standardization is critical for therapeutic consistency. The final liquid extract form frequently utilizes ethanol as a primary base vehicle to ensure solubility and product stability.

The General Therapeutic Purpose of Kamillosan

The overarching purpose of Kamillosan is to deliver localized relief by addressing irritation and mitigating minor, surface-level inflammation where applied. This is achieved through the combined effect of its direct soothing action and underlying antiseptic action.

The general use of the product is therefore centered on supporting the natural recovery of irritated tissues and mucous membranes. This mechanism serves to calm discomfort and reduce redness associated with low-grade, non-serious topical and mucosal irritations, providing symptomatic management through defined biological actions.

Regulatory References

  1. About EMA
  2. EMA Herbal Monograph

What side effects are possible with Kamillosan?

Possible Side Effects and Safety Information

The safety profile of Kamillosan, which contains extracts from the chamomile flower, is primarily defined by the potential for allergic reactions and restrictions on its use in specific populations.

Adverse Reactions and System Organ Classes

The most important documented adverse effects are related to the Immune System Disorders and Skin and Subcutaneous Tissue Disorders.

Adverse Reaction Category Frequency Classification System-Organ Class Involved
Allergic Reactions, Hypersensitivity Very Rare / Not Known Immune System Disorders
Anaphylaxis Reactions Very Rare Immune System Disorders
Skin Reactions Not Known Skin and Subcutaneous Tissue Disorders

Serious adverse reactions, such as anaphylaxis reactions, have been reported with a very rare frequency for specific formulations, underscoring the potential for severe hypersensitivity. The frequency of general allergic reactions is classified as very rare or not known depending on the formulation and reporting basis.

Safety Restrictions and Special Populations

Official regulatory documents note several safety-related restrictions and special population considerations:

  • Contraindications: Use is strictly prohibited if a patient has a known allergy (hypersensitivity) to chamomile (Matricaria recutita), other plants of the Compositae family (such as yarrow, mugwort, or chrysanthemums), or any of the product’s other ingredients.
  • Pregnancy: For the oral solution, use during pregnancy is generally not recommended due to insufficient data and the product's alcohol (ethanol) content. The alcohol content also requires consideration for patients with liver disease or epilepsy.
  • Breastfeeding: Similar to pregnancy, use of the oral solution is generally not recommended due to a lack of sufficient data on its excretion into breast milk.
  • Pediatric Use: Use in children under 12 years of age is not recommended due to an absence of specific safety data for this age group.

This documented safety structure focuses on the risk of hypersensitivity as the main concern and formally limits its application in certain populations where safety data is incomplete or where ingredients pose a known risk.

Overdose and Emergency Response

Overdose and When to Seek Help

This section summarizes the officially documented overdose information for Kamillosan, a traditional herbal medicinal product, based strictly on government regulatory documents.

Overdose Profile Summary

For the active herbal constituents (Matricaria Chamomilla extract), regulatory documentation generally states that no known symptoms of overdosage have been reported when the product is used as directed.

Feature Official Regulatory Status
Documented Overdose Signs None reported for the herbal component.
Antidote Information No specific antidote is documented.
Management Measures Management is generally focused on symptomatic treatment.

Urgent Help-Seeking Requirements

The primary, officially documented risk associated with excessive intake relates to the excipient (non-active substance) in the concentrated liquid extract formulation:

  • Risk to Children: Accidental ingestion of a large, concentrated volume presents a specific danger to life for children due to the product’s high ethanol (alcohol) content. This risk is classified as a severe outcome related to the excipient, not the herbal extract.
  • Mandatory Action: If accidental concentrated ingestion occurs, especially involving children, official labeling mandates that users consult a doctor immediately or contact a Poison Center. This immediate consultation is required even if symptoms have not yet developed.
  • Population Considerations: The alcohol content must be specifically considered for children and patients with an increased risk due to liver disease or epilepsy.

Therapeutic Uses of Kamillosan

What Kamillosan Treats: Main Uses and Benefits

This preparation is a traditional herbal medicinal product commonly used for supportive symptom management across several domains. It is primarily relevant in contexts involving acute or disruptive symptom patterns linked to minor irritation and inflammation of tissues.

Kamillosan is used to help address symptom clusters that may become disruptive, specifically the burning, localized pain, and soreness associated with minor ulcers and inflammations of the mouth and throat, and is relevant for easing symptoms related to inflammatory or irritative states of the skin, such as those that appear with minor sunburn or small superficial wounds. The product supports general well-being during symptomatic phases, assisting with maintaining functional stability.

The preparation is applicable for use involving acute or disruptive symptom patterns of a minor, superficial nature.

It is further applied across domains where additional symptomatic support is needed, such as when used for managing symptoms related to irritations in the anal and genital regions, or for the symptomatic relief of minor gastrointestinal complaints and the symptoms of common cold via inhalation. These applications help ease the overall symptom burden in situations where symptoms interfere with daily functioning.


Quick Fact: Relief for Localized Irritation
Primary Symptom Focus Burning, localized pain, redness, itching, and soreness
Condition Categories Minor oral ulcers, superficial gum and skin inflammation, mild wounds, and chafing
Patient Benefit Supports symptom management and contributes to improved comfort during symptomatic periods

Regulatory References

  1. European Medicines Agency's traditional use monograph on Matricariae flos

Eligibility and Restrictions for Use

Eligibility Map: Who can and Cannot Use Kamillosan

This eligibility profile is defined by official population rules found in government regulatory documents and is not medical advice.

Population Status Eligibility Rule Regulatory Basis
Allowed Use Adults and adolescents aged 12 years and over Standard use is established for this age group.
Contraindicated Patients with known allergy to chamomile (Matricaria Chamomilla) or other plants of the Asteraceae (Composite) family. Absolute exclusion due to hypersensitivity.
Use Not Recommended Children under 12 years of age. Not recommended due to lack of data to support safe use.
Use Not Recommended Pregnant and breastfeeding women. Not recommended due to insufficient data on safety during these periods.

Condition-Specific Restrictions (Internal Use)

Kamillosan liquid concentrate contains a high concentration of ethanol (alcohol), which triggers specific non-eligibility rules:

  • Absolute Prohibition: The product is contraindicated for internal ingestion (oral use) in patients suffering from alcoholism.
  • Mandatory Caution: The alcohol content must be taken into account for patients with liver disease or epilepsy, necessitating restricted or conditional use.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Kamillosan, a Traditional Herbal Medicinal Product, strictly as described in governmental regulatory documentation.

Pharmacodynamic and Excipient Interactions

The regulatory interaction profile is defined by two primary domains, rather than formal pharmacokinetic interactions with specific systemic drug classes. The first domain concerns pharmacodynamic interactions stemming from the mild sedative activity traditionally associated with the chamomile extract.

Co-administration with other medicinal products that cause drowsiness or have known sedative properties may result in an additive effect, potentially increasing the degree of sedation. This is a cautionary note based on the known activity of the herbal constituents.


The second documented domain is an excipient-based interaction specific to the liquid concentrate formulation. The product contains a high concentration of ethanol (alcohol). This excipient content necessitates a formal regulatory caution regarding concurrent use with alcohol consumption and with other medicines that are known to interact with alcohol or induce a disulfiram-like reaction.

Regulatory documentation does not formally list specific medicinal products as contraindicated combinations, nor does it specify timing requirements for dose separation.

Mechanism of Action

The mechanism of action initiates at the cellular signaling level where Levomenol inhibits key upstream transcription factors, including Nuclear Factor kappa B ( NF-kappa B) and the Mitogen-Activated Protein Kinase ( MAPK) pathways. By blocking the activation and nuclear translocation of NF-kappa B, the active components suppress the transcription of genes that code for numerous pro-inflammatory enzymes and chemical messengers. This suppression of NF-kappa B signaling regulates the transcription of pro-inflammatory genes.

The inhibition of inflammatory signaling cascades leads to a downstream consequence: the reduced activity of the enzyme Cyclooxygenase-2 (COX-2). The combined action of Levomenol and Chamazulene lowers the synthesis of Prostaglandin E2 ( PGE2), a powerful mediator that drives local vascular changes. This mechanism results in the physiological consequence of attenuated micro-edema and reduced vasodilation at the site of application.

The components work synergistically; while Levomenol suppresses the initiation signal, Chamazulene complements this by modulating the p38/ COX-2 axis and activating the anti-inflammatory nuclear receptor PPARgamma. This multi-target mechanism results in the localized modulation of the inflammatory response, which adjusts excessive signaling on mucosal and superficial surfaces.

Dosage and Administration Information

Official Administration Guidelines

Kamillosan is a traditional herbal preparation characterized by its localized administration, which varies depending on the affected area. The available formulations—primarily the liquid concentrate, cream, and ointment—determine the intended routes, which include oromucosal use (rinsing/gargling), cutaneous use (topical application, washes, baths), and steam inhalation.

Standard Regimens and Preparation

Proper use of the concentrated solution necessitates dilution with water before application. For adults and adolescents, the regimen for oromucosal use, such as rinsing or gargling, typically involves mixing 5 to 10 mL of the concentrate with a defined volume of warm water for a single dose. This preparation is then applied multiple times daily, often three to four times, in an as-needed pattern. Topical use of semi-solid forms is achieved by applying a thin layer to the skin or by using the diluted liquid concentrate for washes and compresses, generally performed several times per day.

Application Method Typical Adult Dose Range Frequency Pattern
Oromucosal Rinse/Gargle (Concentrate) 5–10 mL diluted in water 3–5 times daily
Cutaneous/Topical (Cream/Ointment) Thin layer application Several times daily
Inhalation (Concentrate) Specified volume diluted in hot water As needed, multiple times daily

Course Duration and Age Rules

Use is restricted to short-term symptomatic management. If symptoms persist longer than seven days during the course of application, use should be discontinued. Specific age limitations apply; for some concentrated oral forms, use is not recommended for children under the age of 12 years due to insufficient data, while other external applications may be used for children aged six years and older. These instructions define the specific parameters for application.

Recent Clinical Evidence

Kamillosan: Recent Clinical Evidence

Kamillosan, which contains German chamomile (Matricaria recutita) extract, has been the subject of multiple clinical investigations focusing on its potential anti-inflammatory and soothing properties, particularly for conditions affecting the skin and mucous membranes.

Efficacy in Inflammation and Pain

Recent systematic reviews and meta-analyses have examined the efficacy of chamomile-derived products across various conditions. Research has specifically explored its influence on inflammatory pain and mucosal inflammation. A meta-analysis of randomized controlled trials (RCTs) found a statistically significant association between chamomile use and a reduction in pain severity levels, particularly concerning oral mucosal conditions.

Similarly, some studies suggest a significant influence on measures of mucositis severity and mucosal inflammation in the oral cavity. However, other outcomes, such as gum bleeding or the gingival index, did not demonstrate consistent or statistically significant results across all analyzed trials, suggesting variability in findings based on the specific condition studied.

Combination and Topical Use

Research has also investigated the extract’s use in topical applications, such as for inflammatory skin conditions. In one partially double-blind study, a chamomile cream was evaluated in comparison to a low-dose hydrocortisone cream and a placebo vehicle for patients with medium-degree atopic eczema. Results suggested a mild association with improvement, though the difference compared to the vehicle cream was marginal.

Safety Profile Observed in Studies

In the context of the clinical trials reviewed, the chamomile extract was generally described as well-tolerated by participants. Across the aggregated data, no consistent serious adverse events were reported, with a limited number of participants discontinuing trials due to minor adverse effects.

Frequently Asked Questions (FAQ)

Common questions about Kamillosan (FAQ)

Q: Is Kamillosan available over the counter, or do I need a prescription?

According to official regulatory classifications in many territories, Kamillosan is categorized as a medicine available only at a pharmacy. This means it is generally available over the counter (OTC) and does not require a doctor's prescription for purchase.

Q: Is Kamillosan the same as pure chamomile extract?

Kamillosan is not simply a generic extract. It is a standardized extract derived from a specific, high-yield type of chamomile called Manzana. This standardization process is used to ensure a consistent, defined amount of the active ingredients, which is important for the product's quality and therapeutic consistency.

Q: Does Kamillosan contain any alcohol or sugar?

The concentrated liquid formulation of Kamillosan contains a high percentage of ethanol (alcohol), which is used as a base vehicle for solubility and stability. Regarding sweeteners, official ingredient lists provided in the product information generally do not specify the addition of sugar.

Q: Can Kamillosan be used to soothe irritation from dentures or braces?

Official regulatory indications for the product's oral use include addressing inflammation and irritation within the mouth. This scope specifically covers conditions like pressure ulcers caused by dentures. The product is generally intended to soothe minor irritations of the mucous membrane.

Q: Is the Kamillosan spray formulation different from the liquid extract?

Regulatory documents show that Kamillosan products authorized as a spray often have a different composition than the concentrated liquid extract. Depending on the territory, the spray may include additional active components, such as various essential oils and other compounds, alongside the chamomile extract.

Q: Are there any official restrictions on driving or operating machinery while using Kamillosan?

Official product information notes that no dedicated studies have been conducted to assess the effects of Kamillosan on a person's ability to drive or use machinery. The product's sedative activity is described as mild, and official information does not provide a formal assessment of these effects.

Q: Is there evidence for Kamillosan's use in dental procedures?

Yes, for certain formulations, official regulatory indications include use for pain and inflammation that may arise after a tooth extraction. The product is also indicated for conditions like gingivitis and parodontosis, which relate to the health of the gums and supporting dental structures.

Q: Are there any regulatory warnings about mixing Kamillosan with hot water or other liquids?

The official instructions for use specify that the concentrate must be diluted with water, using either warm water for rinsing and gargling, or hot water for steam inhalation. Official product warnings generally do not contain information about mixing the concentrate with other types of liquids.

Q: Does Kamillosan have specific use conditions related to sun exposure?

In some regulatory documents, the product's authorized uses for the skin include helping to treat minor surface inflammations, such as sunburn. However, official warnings do not typically list restrictions about sun exposure while a person is using the product.

Q: Why do some official sources mention Kamillosan for internal use while others only mention external use?

The reason for the difference lies in varying national regulatory approvals. Some government bodies have authorized Kamillosan formulations for traditional internal use, such as for digestive complaints. However, in other regions, regulatory authorization is restricted strictly to external or topical use, including application on the skin or mucous membranes in the mouth.

How should Kamillosan be stored and disposed of?

Official Storage Requirements

Storage rules for Kamillosan liquid extract are defined to ensure product stability and safety. The medicine must be kept in the original container at all times. The primary temperature constraint applies after the first opening: the product must not be stored above 25°C. For the unopened product, no special storage conditions are typically required.

Stability and Child Safety

The medicine has a labeled shelf life of one year (12 months) after the container is first opened. Consumers must strictly adhere to the expiration date printed on the packaging. The product must be kept out of the sight and reach of children as a mandatory safety requirement.

Disposal Instructions

Unused or expired Kamillosan must not be disposed of in wastewater or ordinary household waste. To protect the environment, consumers are required to ask a pharmacist for instructions on how to properly discard the medicine.

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

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