Valid Ghana · FDA Ghana

STARBALM COLD SPRAY

Menthol/ MN/Eucalyptus Oil

FDA/SD.243-050841 Menthol/ MN/Eucalyptus Oil INN generic

What it does

Eucalyptus is a natural remedy often used for its soothing properties, especially for respiratory issues.

Commonly used for: coughs, cold symptoms, respiratory infections

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.243-050841
Registration date
2024-05-27
Expiry date
2027-04-01
Status
Valid
Active ingredient
Menthol/ MN/Eucalyptus Oil
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
319781
Manufacturer / MAH
Novum Pharma
Country of origin
Netherlands

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:38 · updated 2026-09-18 04:00:07

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About eucalyptus

Eucalyptus is a natural remedy often used for its soothing properties, especially for respiratory issues.

What it treats

  • coughs
  • cold symptoms
  • respiratory infections

How it works

Eucalyptus contains compounds that can help relieve symptoms by reducing inflammation and acting as a mild antiseptic.

Who it's for

Eucalyptus is suitable for adults and children, but care should be taken with young children and those with allergies.

Cautions

  • • Avoid if allergic to eucalyptus or related plants.
  • • Use with caution in young children.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About menthol

Menthol is a natural compound often used for its soothing and cooling effects.

What it treats

  • cough relief
  • muscle pain relief
  • skin irritation treatment

How it works

Menthol creates a cooling sensation on the skin and mucous membranes, which can help relieve discomfort.

Who it's for

Menthol is suitable for adults and children who need relief from coughs, muscle aches, or skin irritation.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: eucalyptus

Eucalyptus is a genus of flowering trees and shrubs in the myrtle family, Myrtaceae. The leaves and oil extracted from eucalyptus are commonly used in traditional medicine and as flavoring agents. Eucalyptus oil is known for its antiseptic, anti-inflammatory, and analgesic properties, making it popular in respiratory therapies for conditions such as coughs, colds, and sinusitis.

Indications

  • Respiratory infections
  • Cough and cold symptoms
  • Sinusitis
  • Bronchitis
  • Muscle pain and inflammation

Dosage

Children: Refer to specific product guidelines or consult a healthcare professional for appropriate dosing of eucalyptus oil in children, as it varies based on formulation and indication.

Adults: Refer to specific product guidelines or consult a healthcare professional for appropriate dosing of eucalyptus oil, as it varies based on formulation and indication.

Mechanism of action

Eucalyptus oil contains compounds such as eucalyptol (1,8-cineole) that exhibit antimicrobial properties. It acts on the respiratory system by promoting bronchodilation and reducing mucus production. The oil also has a cooling effect, which can provide relief from symptoms of respiratory distress. Additionally, the oil's anti-inflammatory properties help decrease inflammation in the airways.

Pharmacodynamics

The primary active ingredient in eucalyptus oil, eucalyptol, interacts with the body's inflammatory response and can modulate the activity of neurotransmitters involved in pain signaling. It may enhance mucociliary clearance in the respiratory tract, facilitating the expulsion of mucus and pathogens. The analgesic effects can help relieve discomfort associated with respiratory infections.

Pharmacokinetics

Eucalyptus oil is typically administered via inhalation or topical application. When inhaled, components like eucalyptol are absorbed through the mucous membranes of the respiratory tract and rapidly distributed throughout the body. The oil is metabolized primarily in the liver, and its metabolites are excreted in urine. The half-life of eucalyptol varies but is generally short, necessitating frequent dosing for sustained effects.

Adverse effects

  • Allergic reactions
  • Skin irritation
  • Nausea
  • Vomiting
  • Diarrhea
  • Dizziness

Interactions

  • May interact with anticoagulants, potentially increasing bleeding risk
  • May enhance the effects of other medications that cause sedation

Precautions

  • Use with caution in individuals with asthma or other respiratory conditions
  • Avoid use in young children without medical supervision
  • Eucalyptus oil should not be ingested in large quantities due to toxicity

Pregnancy

Eucalyptus oil is generally considered unsafe in pregnancy due to potential toxicity and should be avoided unless prescribed by a healthcare professional.

Breast-feeding

Caution is advised when using eucalyptus during breastfeeding, as it may pass into breast milk and could affect the infant.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Eucalyptus oil (topical, inhalation, or oral preparations)
  • Eucalyptus leaves (dried for teas or extracts)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: menthol

BNF-referenced

Menthol is a cyclic monoterpene alcohol that is widely used as a flavoring agent and in topical analgesic preparations due to its cooling sensation. It is commonly derived from peppermint oil and is known for its soothing properties in various applications, including cough drops, ointments, and as a fragrance in personal care products.

Indications

  • Topical analgesic for muscle and joint pain
  • Cough suppressant in cough drops and lozenges
  • Relief of minor throat irritation
  • Cooling agent in various cosmetic and personal care products

Dosage

Children: Refer to BNF for Children for specific dosing guidelines, as doses may vary based on age and formulation.

Adults: For topical use, apply a thin layer to the affected area not more than 3 to 4 times daily. For cough drops, follow the product-specific instructions as per the formulation.

Mechanism of action

Menthol acts as an agonist for the transient receptor potential subtype M8 (TRPM8), a non-selective cation channel that is activated by cold temperatures. This activation leads to calcium influx in mast cells, inducing the release of histamine, which can trigger allergic responses such as urticaria, asthma, and rhinitis. Menthol's ability to induce histamine release via TRPM8 suggests potential therapeutic applications for TRPM8 antagonists in managing cold- and menthol-induced allergies.

Pharmacodynamics

Menthol produces a cooling effect by stimulating sensory neurons that convey cold sensations. It interacts with TRPM8 channels, leading to the activation of intracellular signaling pathways that can result in vasodilation and increased blood flow to the area of application. This cooling sensation can provide symptomatic relief in conditions characterized by pain or irritation.

Pharmacokinetics

Menthol is absorbed through the skin and mucous membranes, with systemic effects depending on the route of administration. Its bioavailability can vary, and it is metabolized primarily in the liver. The elimination half-life and excretion pathways have not been extensively characterized, but menthol is generally considered to have a rapid onset of action with effects lasting for a few hours.

Adverse effects

  • Allergic reactions
  • Urticaria
  • Asthma
  • Rhinitis
  • Skin irritation

Precautions

  • Use with caution in patients with known allergies to menthol or related compounds
  • May exacerbate asthma in sensitive individuals

Pregnancy

There are no well-controlled studies of menthol in pregnant women. Menthol should be used during pregnancy only if clearly needed.

Breast-feeding

Menthol is excreted in breast milk. Caution should be exercised when administering to nursing mothers.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Topical ointment
  • Cream
  • Liquid

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: menthol

PubChem CID 1254

Molecular formula: C10H20O

Mechanism of action

Exposure to low temperatures often causes allergic responses or urticaria. Similarly, menthol, a common food additive is also known to cause urticaria, asthma, and rhinitis. However, despite the obvious clinical implications, the molecular mechanisms responsible for inducing allergic responses to low temperatures and menthol have not been determined. Because a non-selective cation channel, transient receptor potential subtype M8 (TRPM8) is activated by cold and menthol, we hypothesized that this channel mediates cold- and menthol-induced histamine release in mast cells. Here, we report that TRPM8 is expressed in the basophilic leukemia mast cell line, RBL-2H3, and that exposure to menthol or low temperatures induced Ca(2+) influx in RBL-2H3 cells, which was reversed by a TRPM8 blocker. Furthermore, menthol, a TRPM8 agonist, induced the dose-dependent release of histamine from RBL-2H3 cells. When TRPM8 transcripts were reduced by siRNA (small interfering RNA), menthol- and cold-induced Ca(2+) influx and histamine release were significantly reduced. In addition, subcutaneous injection of menthol evoked scratching, a typical histamine-induced response which was reversed by a TRPM8 blocker. Thus, our findings indicate that TRPM8 mediates the menthol- and cold-induced allergic responses of mast cells, and suggest that TRPM8 antagonists be viewed as potential treatments for cold- and menthol-induced allergies. /DL-Menthol/ Menthol's characteristic cooling sensation is due, in part, to the activation of sensory neurons generally termed transient receptor potential (TRP) channels, in particular transient receptor potential melastatin family member 8 (TRPM8) and transient receptor potential subfamily A, member 1 (TRPA1). Menthol acts upon TRPM8 receptors by rapidly increasing intracellular calcium and mobilizing calcium flux through the channels to induce cold response signals at the application site. Aside from its cold-inducing sensation capabilities, menthol exhibits cytotoxic effects in cancer cells, induces reduction in malignant cell growth, and engages in synergistic excitation of GABA receptors and sodium ion channels resulting in analgesia. /DL-Menthol/ In recent years, the transient receptor potential melastatin member 8 (TRPM8) channel has emerged as a promising prognostic marker and putative therapeutic target in prostate cancer. We have found that forced overexpression of TRPM8 in PC-3 cells can inhibit the cell proliferation and motility probably through the TRPM8 activation. In this study, we aimed to investigate whether activating the TRPM8 channel by its selective agonist menthol can inhibit the proliferation and motility of androgen-independent prostate cancer (AIPC) with remarkable expression of TRPM8. Menthol is a naturally occurring compound, which has been widely used in cosmetics and pharmaceutical products, and also as flavoring in food. DU145 cells are androgen-independent but have a remarkable expression of TRPM8. The demonstration of the existence of TRPM8 and the absence of TRPA1 in DU145 cells provided the foundation for the following experiments, because both TRPM8 and TRPA1 are molecular targets of menthol. The outcome of MTT assay indicated that menthol inhibited the cell growth (p < 0.01). Cell cycle distribution and scratch assay analysis revealed that menthol induced cell cycle arrest at the G(0)/G(1) phase (p < 0.01). Furthermore, menthol inhibited the migration of DU145 cells by downregulating the focal-adhesion kinase. So it suggests that the activation of the existing TRPM8 channels may serve as a potential and pragmatic treatment for those AIPC with remarkable expression of TRPM8, and menthol is a useful compound for future development as an anticancer agent. /DL-Menthol/

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.