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RUB A-535 Antiphlogistine Ice

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RUB A-535 Antiphlogistine Ice

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Method of action: Locally Irritating

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.

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Overview of RUB A-535 Antiphlogistine Ice

Property Description
Active ingredient Levomenthol (INN)
Form Topical Gel or Rub
Pharmacological class Topical Analgesic / Counterirritant
Route of Administration Topical (External use only)
Type Over-the-Counter (OTC)

What Type of Medicine is RUB A-535 Antiphlogistine Ice?

RUB A-535 Antiphlogistine Ice is a widely available over-the-counter (OTC) medicinal preparation designed for external use. Pharmacologically, it is classified as a Topical Analgesic and belongs to the sub-group of Counterirritants. This means the product is applied directly to the skin, providing localized comfort rather than working internally. The classification as a Counterirritant is defined by its ability to create a strong, superficial sensation that helps distract from deeper aches.

Composition and General Purpose

The sole active ingredient in this preparation is Levomenthol (INN). The product is manufactured as a topical gel or rub in a suitable base, which ensures easy application and absorption through the skin. Levomenthol is the purified, powerful component recognized for its rapid sensory effects, and is related chemically to natural menthol.

What is the General Purpose of this Topical Rub?

The general purpose of the product is to provide immediate, temporary comfort to localized areas of discomfort, such as minor muscle stiffness or tension. It achieves this by generating a strong, distinct ice-like cooling effect through the Levomenthol component. This cooling action quickly activates nerve receptors in the skin, fulfilling the product's primary role as a quick-acting, external preparation to temporarily soothe aches and stiffness.

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What side effects are possible with RUB A-535 Antiphlogistine Ice?

Possible Side Effects and Safety Information

The safety profile for this topical rub, which contains the active ingredient Levomenthol, is primarily characterized by localized effects related to its application as a counterirritant. Adverse reactions are classified by official regulatory sources mainly under Skin and Subcutaneous Tissue Disorders.

Adverse Reactions and Frequency Classification

The most common documented adverse events are localized dermatological reactions. These include local irritation, skin redness (erythema), itching (pruritus), rash, and discomfort at the site of application. The official frequency for these and other possible adverse reactions is often categorized as Not known (cannot be estimated from the available spontaneous post-marketing data), according to government regulatory standards.

Serious Adverse Reactions and Application Restrictions

Although rare, official labeling documents the potential for serious adverse reactions, including severe, intense skin reactions such as blistering or a painful burning sensation that exceeds the expected cooling effect. Signs of a more generalized hypersensitivity reaction (e.g., anaphylaxis) are also listed as a possibility.

The safety profile mandates strict application restrictions to prevent severe local injury and potential systemic exposure. The product must not be applied to open wounds, damaged or irritated skin, or mucous membranes. Additionally, official regulatory documents note that the safety of the product has not been established for use in young children, leading to age restrictions in pediatric populations per regional labeling requirements.

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Overdose and Emergency Response

Overdose and When to Seek Help

Regulatory documents define the severe overdose profile for topical Levomenthol products, such as RUB A-535 Antiphlogistine Ice, primarily in the context of accidental ingestion (swallowing) or inappropriate inhalation, rather than intended topical use. Accidental ingestion is considered a medical emergency due to the potential for severe systemic toxicity.

Documented Overdose Manifestations

System Documented Clinical Signs
Neurological Confusion, unsteadiness (ataxia), dizziness, tremor, convulsions, and unconsciousness (coma).
Gastrointestinal Abdominal pain, nausea, vomiting, and hematuria (blood in urine).
Cardiopulmonary Breathing difficulties, palpitations, and potential respiratory failure.

Required Emergency Actions

Official labeling mandates that emergency medical attention must be sought immediately following any suspected accidental ingestion. Contacting a Poison Help line or emergency services (such as 911) is required if severe systemic symptoms, including passing out or trouble breathing, are observed.

Overdose management is explicitly defined as symptomatic and supportive care, and the official information confirms that no specific antidote is known for Levomenthol poisoning. Infants and young children are noted as a population more susceptible to severe gastrointestinal and respiratory symptoms from ingestion.

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Therapeutic Uses of RUB A-535 Antiphlogistine Ice

What RUB A-535 Antiphlogistine Ice Treats: Main Uses and Benefits

The primary therapeutic utility of this topical rub is generally providing supportive, temporary symptomatic comfort for localized musculoskeletal discomfort, stiffness, and minor aches, which may help contribute to easing the overall symptom load in specific areas. This class of products is commonly used for managing symptoms related to physical discomfort.

Easing Discomfort from Muscle Aches, Stiffness, and Tension

This product is commonly applied to manage localized muscular aches and soreness that may follow physical activity or exertion, or result from general tension. It is used in situations where symptoms cluster around muscular stiffness or localized pain, generally providing a cooling sensation that contributes to general comfort and supports a more manageable experience of post-activity recovery. The product is relevant for symptomatic relief across several common conditions, including simple backache, lumbago, and muscle stiffness.

Targeted Relief for Minor Sprains, Strains, and Joint Aches

The product is considered relevant for symptoms associated with minor soft tissue injuries, such as strains and sprains, and for localized joint pain related to conditions like episodic arthritis pain. Its benefit is offering focused, symptomatic relief, which may assist with easing discomfort during mild to moderate pain manifestations that may interfere with routine activities or daily comfort.

Quick Fact: Relief for Localized Symptoms
Main Use Context: Commonly applied during phases when symptoms become more noticeable, offering supportive relief when general muscular or joint discomfort creates noticeable physiological strain.

Regulatory References

  1. NIH MedlinePlus overview of Menthol Topical
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Eligibility and Restrictions for Use

Eligibility: Who Can and Cannot Use This Topical Rub

The eligibility profile for topical Levomenthol products is defined by strict regulatory guidelines regarding age, application site, and pre-existing conditions. Use is permitted for adults and children 2 years of age and older under standard labeled conditions.


Population Eligibility Status Regulatory Classification
Absolute Contraindication Individuals with a documented hypersensitivity or allergy to Levomenthol or any other ingredient in the product must not use it.
Conditional Non-Eligibility The rub must not be applied to wounds, broken, irritated, or damaged skin. It must also not be used in conjunction with a heating pad or other external heat sources due to burn risk.
Pediatric Restriction Children under 2 years of age must not use the product without first consulting a doctor, as safety is not established for this age group.
Life Stage Restriction Individuals who are pregnant or breast-feeding are advised by regulators to ask a health professional before use.

The regulatory documentation thus establishes mandatory boundaries for use, ensuring that specific populations with heightened risks or conditional requirements seek professional guidance before application.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

RUB A-535 Antiphlogistine Ice contains the active ingredient Levomenthol, a topical analgesic designed for external use. Due to its minimal systemic absorption, official government regulatory documents do not generally document formal systemic pharmacokinetic interactions, such as those involving major metabolic enzymes (CYP450) or drug transporters.


Documented Local and Administration-Related Constraints

The regulatory profile for this topical product is defined by constraints related to local co-administration rather than systemic drug interactions. These restrictions are stated in official labeling to manage local effects at the application site.

Interaction Type Constraint Defined by Regulatory Labeling
Co-Application Restriction Must not be co-administered with other topical pain relievers on the same area of the body.
External Heat Prohibition Must not be used with heating pads or any external heating device on the treated area.

These official statements structure the product's interaction management, focusing strictly on local application safety and prohibiting the concurrent use of external heat or other topical analgesics on the same site. No formal contraindications with systemic medicinal products are documented in the regulatory labeling.

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Mechanism of Action

Sensory Nerve Modulation and Counter-Irritation

This immediate action is driven by Menthol and Camphor acting as agonists on Transient Receptor Potential (TRP) channels, primarily the TRPM8 cold receptor. This rapid modulation of somatosensory pathways creates the intense sensation of cold, which transmits a competing afferent signal, altering the perception of nociceptive input. This initiates a rapid, localized alteration of somatosensation.


Deep Anti-Inflammatory Action

The COX-inhibitory component operates through the absorption and metabolism of Methyl Salicylate into Salicylic Acid. This mechanism targets and inhibits Cyclooxygenase (COX) enzymes, reducing the synthesis of pro-inflammatory prostaglandins. This biochemical blockade modulates the inflammatory cascade, resulting in the attenuation of pro-inflammatory signaling and associated localized edema.


Neural Desensitization and Dual Response

Camphor further contributes to modulation by activating both cold- and warm-sensitive receptors (TRPV1/TRPV3), inducing a secondary, sustained effect of nerve desensitization. This process lowers the sensitivity and responsiveness of peripheral pain neurons, initiating a reduction in sensory neuron excitability, which influences subsequent nociceptive input.

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Dosage and Administration Information

The use of Levomenthol topical products, such as RUB A-535 Antiphlogistine Ice, is governed by structured, non-prescriptive directions for use outlined in regulatory labeling. The administration route is strictly topical and intended for external application to the affected areas of the skin, and is not for internal consumption.

Application and Frequency

The standard regimen directs adults and children (typically 2 years of age and older, or 12 years and older, depending on the specific product label) to apply a thin film or layer of the gel or rub to the site of discomfort. This qualitative dose should be gently massaged into the skin until it is fully absorbed. The product is intended for as-needed use, and should be applied not more than three to four times daily.

Procedural Constraints and Duration

Official instructions mandate specific procedural constraints. The rub must be applied only to intact skin and should not contact the eyes or mucous membranes. Furthermore, the area should not be wrapped tightly (occlusive dressing) or exposed to external heat sources, such as a heating pad, after application. Users are directed to wash hands thoroughly with soap and water immediately after use, unless the hands are the area being addressed. The use of this preparation is limited to temporary, short-term periods; if the condition persists for more than seven days, a health professional must be consulted. For children under the age limit specified on the label (e.g., under 12 years or 2 years), use requires the consultation of a physician.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Levomenthol Topical Rub


Evidence for Temporary Relief of Localized Muscle Aches and Stiffness

Research has primarily focused on adults, including healthy volunteers and individuals experiencing acute, episodic discomfort, often through short-term randomized controlled trials and various controlled intervention studies. These studies used rigorous methods to examine patient-reported experiences and outcomes related to physical discomfort. Research has explored how symptoms change over a defined, short time interval following application.

Studies monitored outcomes related to perceived discomfort and how patients reported their experience using rating scales, and they also examined physical measures such as the Pain Pressure Threshold (PPT). Findings from these trials describe patterns observed in the studies, often reporting measured changes in the local pain sensitivity (PPT) and reports related to short-term perceived discomfort compared to an inactive product (placebo). This research provides insight into short-term changes and contributes to the broader evidence landscape regarding topical counterirritants.

Research on Minor Sprains, Strains, and Joint Discomfort

This area will outline the evidence base, which primarily involves regulatory acceptance within the counterirritant drug class, that supports the rub's inclusion in regulatory standards for its intended temporary symptomatic use associated with minor soft tissue injuries and episodic joint aches.

In these contexts, research focuses on patient-reported outcomes describing perceived discomfort. Evidence highlights what research has explored—that the product's use is examined for short-term symptom changes—but comparative evidence is lacking to directly assess its effect on specific markers of recovery or structural outcomes for sprains and strains. The findings describe group patterns related to temporary perceived discomfort, but the research does not determine whether an individual will respond similarly to all forms of topical pain relief.


Overview of Long-Term Studies and Research Gaps

The majority of published studies that researched this topical rub and similar counterirritants focus on episodes where symptoms become more noticeable, which translates to very short-term observation periods. While some large-scale regulatory summaries may cover longer periods of generalized usage, follow-up durations were limited for the specific temporary change outcome.

As a result, there is limited information for long-term outcomes regarding sustained symptomatic change or durability of effect. Data for certain groups remain limited; for instance, findings often apply only to the populations studied, such as healthy adults or those with simple muscle soreness, and data for certain groups remain insufficient for specific populations like older adults or individuals with complex chronic musculoskeletal conditions.

Key Studies & References

  1. Menthol (Topical Route) MedlinePlus Drug Information
  2. The Analgesic and Anti-inflammatory Effects of Essential Oils: A Review of the Research Evidence
  3. Effects of topical menthol on cutaneous blood flow and pain sensitivity
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Frequently Asked Questions (FAQ)

Common questions about RUB A-535 Antiphlogistine Ice (FAQ)

Q: Can this product be used for nerve pain, or only muscle pain?

A: Official labeling describes the product's intended use for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, strains, and sprains. It is classified as a counterirritant, which means it works by applying a sensation to the skin that alters the perception of the discomfort through local nerve pathways.


Q: Is the product generally considered safe for use by older adults?

A: The product is intended for temporary use. General official guidance for similar topical products suggests that individuals 60 years or older may have more sensitivity to side effects and should use the product with care. A healthcare professional should be consulted if there are specific health concerns, as noted in general guidance.


Q: Can I use this product if I am pregnant or breastfeeding, according to official guidelines?

A: Official product information suggests a healthcare professional be consulted regarding use during pregnancy or breastfeeding. It is particularly noted that products containing methyl salicylate (a related compound) should not be used late in pregnancy unless advised by a doctor.


Q: What is the generally accepted age limit for using this product?

A: Official labeling states the product is generally for use by adults and children 12 years of age and older. Since the safety of the product has not been established for very young children, consultation with a physician is necessary for use in individuals younger than the age stated on the label.


Q: Can people with asthma or respiratory sensitivities use this product?

A: Due to the active ingredient, Levomenthol, general guidance suggests that individuals with certain respiratory sensitivities, such as asthma or nasal polyps, should consult with a healthcare professional before use.


Q: Is it normal to feel a strong cold sensation followed by warmth?

A: The active ingredient, Levomenthol, is primarily responsible for creating a strong, ice-like cooling sensation on the skin. Other active ingredients that may be included in the full formulation, such as camphor, are described in pharmacological texts as having a dual action on both cold- and warm-sensitive receptors.


Q: How is the pain relief from this product generally described in research?

A: Regulatory summaries of the research indicate that studies examine patient-reported outcomes related to perceived discomfort over short periods. The evidence supports the product’s use for temporary, short-term symptomatic relief associated with minor muscle and joint aches.


Q: What does 'Antiphlogistine' mean in the product name?

A: The term 'Antiphlogistine' is a historical reference, derived from Greek roots. In a medical context, it refers to a substance that is intended to act against or counteract inflammation or fever.


Q: Can I use this product on my face or sensitive areas?

A: Official warnings state to strictly avoid contact with the eyes and all mucous membranes. This aligns with general cautions against use on sensitive areas like the face. The product must also not be applied to damaged or irritated skin.


Q: What happens if a small amount of the product accidentally gets into the eyes?

A: In the event the product accidentally contacts the eyes, official guidance for similar topical rubs recommends rinsing the eyes immediately and thoroughly with plenty of cool tap water.


Q: Is there a maximum number of days the product is intended to be used?

A: This topical rub is intended for temporary, short-term use only. Official product information indicates that a health professional should be consulted if the condition persists for more than seven days or if symptoms clear up and reappear within a few days.


Q: Has there been research on using this product for fibromyalgia or chronic conditions?

A: Official regulatory summaries indicate that the majority of research focuses on acute, episodic discomfort over short-term observation periods. Data remains limited or insufficient regarding long-term outcomes or use in populations with complex chronic musculoskeletal conditions.


Q: Can people with sensitive skin generally use RUB A-535 Ice?

A: The product’s safety profile notes that common side effects include local skin irritation, redness, itching, and rash. Consultation with a healthcare professional is generally recommended for individuals with pre-existing skin sensitivities or known allergies to ingredients like menthol or aspirin-related substances before using the product.


Q: Can people with diabetes or circulation issues use this product?

A: While the product is for external use on intact skin only, official guidance for similar topical analgesics suggests that individuals with certain pre-existing conditions, such as high blood pressure, heart disease, or kidney disease, consult a healthcare professional before use.


Q: Can I apply other lotions or moisturizers over the top of the product?

A: Regulatory labeling prohibits co-administration with other topical pain relievers on the same area of the body. The label does not contain formal constraints regarding the use of non-medicated lotions or moisturizers.


Q: What is the official information regarding accidental exposure to pets?

A: Official guidance mandates that the product be stored securely and kept out of reach of both children and pets. If exposure is suspected, a veterinarian or a poison control center should be contacted immediately, as accidental ingestion or licking of products containing menthol can potentially cause adverse effects in pets.


Q: Can athletes use this product under official anti-doping rules?

A: The active ingredient, Levomenthol, and its pharmacological class are not currently included on the World Anti-Doping Agency (WADA) Prohibited List. The topical application of non-prohibited substances is generally permitted at all times.


Q: What does official guidance say about using the product for tension headaches on the neck?

A: Official product labeling describes the product's use for the temporary relief of minor aches and pains of muscles and joints, such as muscle stiffness or backache. Any use must adhere strictly to the instruction to only apply a thin film to the affected area.


Q: Are there any ingredients that might trigger an allergic reaction?

A: Official documents note the potential for rare, severe generalized hypersensitivity reactions. Common adverse effects include local skin reactions like rash and itching. Consulting a health professional is advised for individuals with known allergies to menthol or aspirin-related substances prior to use.

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How should RUB A-535 Antiphlogistine Ice be stored and disposed of?

How to Store and Dispose of RUB A-535 Antiphlogistine Ice

The official labeling for this topical product defines specific storage and disposal requirements to ensure product stability and household safety.


Storage Conditions

  • Temperature: Store the product at controlled room temperature, specifically maintained between 15 C and 25 C.
  • Protection: The product must be protected from freezing and exposure to direct sunlight.
  • Container Rules: Keep the container tightly closed when not in use. Do not use the gel if the safety seal is broken or missing.
  • Child Safety: It is mandatory to KEEP OUT OF REACH OF CHILDREN.

Disposal Instructions

Unused or expired contents and the product container must be disposed of strictly in accordance with local, regional, national, and international regulations for pharmaceutical waste. Do not pour the contents down a drain or dispose of them in household trash without confirming local guidelines.

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

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