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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Biofreeze Colorless
Generic Name
Menthol
Active Ingredient
Menthol, Unspecified FormCategory
Standardized Chemical Allergen [EPC]
Variants
2
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 40 mg/mL | GEL | TOPICAL | 59316-103 |
| 40 mg/mL | GEL | TOPICAL | 50090-6361 |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Biofreeze Colorless, you must consult a qualified healthcare professional.
Detailed information about Biofreeze Colorless
Menthol, Unspecified Form is a versatile compound used primarily as a topical analgesic and counterirritant. It belongs to several pharmacological classes including Standardized Chemical Allergens and Amide Local Anesthetics, providing relief for minor aches and pains.
For topical application, Menthol, Unspecified Form is typically used as follows:
No dosage adjustments are typically required for topical use due to low systemic absorption. However, patients with severe renal failure should use extensive topical applications with caution.
No specific adjustments are required for topical use. Systemic use (oral) should be monitored in patients with significant liver dysfunction.
Elderly patients may have thinner skin, which can increase the risk of irritation or systemic absorption. It is recommended to start with the lowest effective concentration.
If you miss a dose, apply it as soon as you remember. If it is almost time for the next application, skip the missed dose. Do not double the amount applied to 'catch up.'
Signs of topical overdose include severe skin redness, burning, or blistering. If ingested, menthol can be toxic, leading to symptoms such as abdominal pain, dizziness, vomiting, rapid heartbeat, and in severe cases, seizures or coma. In case of ingestion, contact a Poison Control Center or seek emergency medical help immediately.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most patients tolerate topical Menthol, Unspecified Form well. Common reactions include:
Menthol, Unspecified Form is for external use only. It should never be applied to open wounds, damaged skin, or sensitive areas like the eyes and genitals. If the product gets into the eyes, rinse thoroughly with cool water for several minutes.
No FDA black box warnings for Menthol, Unspecified Form.
There are no absolute drug-drug contraindications for topical menthol. However, it should not be used simultaneously with other topical medications on the same skin site unless directed by a physician, as this can alter the absorption of both drugs.
Menthol, Unspecified Form is generally considered safe for localized topical use during pregnancy when used as directed. It is often categorized as FDA Pregnancy Category B (or equivalent). However, extensive use over large surface areas should be avoided, as there are no well-controlled studies on the effects of high systemic menthol levels on fetal development. Always consult a healthcare provider before use during the third trimester.
Menthol is excreted into breast milk in small amounts when ingested, but topical application to areas away from the breast is unlikely to affect a nursing infant. Crucial: Do not apply menthol-containing products to the breast or nipple area, as the infant may ingest the medication during nursing, which can lead to serious respiratory distress or choking.
Menthol is approved for use in children over 2 years of age in low concentrations (e.g., chest rubs). However, products with high concentrations (above 5-10%) are generally restricted to children over 12. Pediatric use requires strict supervision to prevent accidental contact with eyes or mouth.
Menthol, Unspecified Form is a TRPM8 agonist. TRPM8 is an ion channel that, when activated by menthol or cold temperatures, allows the entry of sodium and calcium ions into the cell, resulting in depolarization of the sensory neuron and the perception of a 'cooling' sensation. It also exhibits desensitization of nociceptors (pain receptors) over time and inhibits voltage-gated sodium channels similarly to amide local anesthetics.
Onset of the cooling sensation typically occurs within 1-5 minutes of topical application. The duration of the analgesic effect usually lasts between 30 minutes and 2 hours. Menthol does not appear to cause significant pharmacological tolerance with intermittent use.
| Parameter | Value |
|---|---|
| Bioavailability | <5% (Topical); High (Oral) |
| Protein Binding | ~25% |
Common questions about Biofreeze Colorless
Menthol, Unspecified Form is primarily used as a topical analgesic to provide temporary relief from minor aches and pains associated with muscles and joints. It is commonly found in over-the-counter products for arthritis, backaches, and sports-related strains or sprains. Additionally, it is used in throat lozenges to soothe coughs and minor sore throat irritation. Some medical professionals also use it as a standardized allergen in patch testing to diagnose skin sensitivities. Always consult your doctor to ensure it is appropriate for your specific symptoms.
The most common side effects are localized to the area of application and include a strong cooling sensation, tingling, or mild redness of the skin. These effects are usually temporary and are part of the drug's intended pharmacological action. Some users may experience mild skin irritation or dryness, especially with alcohol-based gel formulations. If you notice severe burning, blistering, or a rash that spreads, you should stop using the product immediately. Contact your healthcare provider if any skin reaction persists for more than a few days.
There are no known direct contraindications between the use of topical Menthol, Unspecified Form and the consumption of alcohol. Because topical menthol has very low systemic absorption, it does not typically interact with substances in the bloodstream. However, heavy alcohol use can sometimes increase skin sensitivity or vasodilation, which might theoretically alter how the skin reacts to the medication. If you are using oral menthol products or have severe liver disease, you should discuss alcohol consumption with your doctor. Always use medications as directed on the label or by a professional.
Menthol, Unspecified Form is generally considered safe for use during pregnancy when applied topically to small, localized areas for short periods. There is no evidence suggesting that occasional use of menthol creams or lozenges poses a significant risk to the developing fetus. However, because comprehensive clinical trials in pregnant women are limited, healthcare providers usually recommend avoiding extensive application over large areas of the body. It is particularly important to consult your obstetrician before use in the third trimester. Always inform your healthcare team about any OTC products you use during pregnancy.
When applied topically, Menthol, Unspecified Form typically begins to produce a cooling sensation within 1 to 5 minutes. This rapid onset is due to the quick activation of TRPM8 receptors on the surface of the skin's sensory nerves. The peak analgesic effect is usually reached within 15 to 30 minutes of application. For oral lozenges, the soothing effect on the throat is often felt almost immediately as the lozenge begins to dissolve. The duration of relief generally lasts between one and two hours, after which another dose may be required according to package instructions.
Yes, Menthol, Unspecified Form can be stopped suddenly without any risk of withdrawal symptoms or physical dependence. Since it is a topical agent that works primarily on local nerve receptors rather than the central nervous system, there is no need for a tapering schedule. If you were using it for chronic pain and stop, your original symptoms may return. If your pain does not improve after 7 days of use, or if it worsens, you should discontinue the product and see a doctor. Sudden discontinuation is safe, but the underlying condition may require alternative treatment.
If you miss a dose of Menthol, Unspecified Form, simply apply it as soon as you remember. If it is nearly time for your next scheduled application, skip the missed dose and return to your regular routine. Do not apply extra cream or use multiple patches at once to make up for a missed dose, as this increases the risk of skin irritation or chemical burns. Because menthol is often used on an 'as-needed' basis for pain, missing a dose is generally not a medical concern. Following the recommended daily frequency (usually 3-4 times daily) is the best way to maintain relief.
There is no clinical evidence to suggest that Menthol, Unspecified Form causes weight gain. Whether applied topically or used in oral lozenges, menthol does not affect the body's metabolic rate, insulin levels, or appetite in a way that would lead to changes in body mass. Because it is not a systemic steroid or a hormonal medication, it lacks the mechanisms typically associated with drug-induced weight changes. If you experience unexpected weight gain while using any medication, it is likely due to other factors or underlying health conditions. You should discuss any significant weight changes with your healthcare provider.
Menthol, Unspecified Form can generally be used alongside most oral medications, but caution is advised with certain combinations. Specifically, patients taking the blood-thinner warfarin should be careful, as some menthol-containing products may increase the risk of bleeding. You should also avoid applying other topical creams, ointments, or 'liniments' to the same area of skin at the same time as menthol. This can lead to unpredictable absorption or severe skin irritation. Always provide your doctor or pharmacist with a full list of your current medications and supplements to check for potential interactions.
Yes, Menthol, Unspecified Form is widely available as a generic product and is a primary ingredient in hundreds of store-brand topical analgesics. Generic versions are required by the FDA to have the same quality and efficacy as brand-name products. You can find it in various forms, including generic 'muscle rubs,' 'cooling gels,' and 'medicated patches' at most pharmacies and grocery stores. Because it is an off-patent, naturally derived or easily synthesized compound, generic versions are typically very affordable. Check the 'Active Ingredients' section of the label to confirm the concentration of menthol.
Other drugs with the same active ingredient (Menthol, Unspecified Form)
> Warning: Stop taking Menthol, Unspecified Form and call your doctor immediately if you experience any of these.
Prolonged use of Menthol, Unspecified Form on the same skin area may lead to chronic skin irritation or sensitization, making the user more likely to develop allergic reactions to mint-related products in the future.
No FDA black box warnings currently exist for Menthol, Unspecified Form. However, the FDA has issued safety communications regarding the risk of serious skin burns with certain OTC topical muscle and joint pain relievers containing menthol.
Report any unusual symptoms to your healthcare provider.
No routine lab tests are required for standard topical use. However, if using menthol as part of a diagnostic allergen panel, healthcare providers will monitor the skin for 48 to 72 hours to evaluate the reaction.
Topical menthol does not typically interfere with the ability to drive or operate machinery. However, if oral ingestion occurs, dizziness may result, and these activities should be avoided.
There are no known direct interactions between topical menthol and alcohol. However, alcohol can cause vasodilation, which might theoretically increase the absorption of menthol if applied over large areas.
Menthol can be stopped abruptly without a tapering schedule. If pain persists for more than 7 days or clears up and occurs again within a few days, consult a doctor as this may indicate a more serious underlying condition.
> Important: Discuss all your medical conditions with your healthcare provider before starting Menthol, Unspecified Form.
There are no significant food interactions with topical menthol. For oral lozenges, avoid consuming very hot liquids immediately after use, as the cooling sensation may mask the temperature and lead to accidental burns in the mouth.
Menthol, Unspecified Form is not known to interfere with common blood or urine laboratory tests. It may, however, interfere with skin patch testing for other allergens if applied to the test site shortly before the diagnostic procedure.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Patients who are sensitive to Carvone (found in spearmint) or other terpene compounds may exhibit cross-sensitivity to Menthol, Unspecified Form. If you have a history of 'mint allergy,' a small patch test is recommended before full application.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Menthol, Unspecified Form.
Elderly patients are at a higher risk for skin breakdown. Clinical data suggests that the cooling sensation of menthol can sometimes mask the symptoms of underlying vascular issues in the limbs. Use with caution in patients with peripheral neuropathy or poor circulation.
No specific GFR-based dose adjustments are required for standard topical applications. Menthol is not effectively cleared by dialysis, but this is rarely a clinical concern given the route of administration.
In patients with Child-Pugh Class C impairment, systemic clearance of absorbed menthol is reduced. Limit use to small, localized areas and monitor for signs of systemic toxicity such as lethargy or confusion.
> Important: Special populations require individualized medical assessment.
| Tmax | 0.5 - 1 hour (Oral/Buccal) |
| Metabolism | Hepatic (Glucuronidation) |
| Excretion | Renal (>90% as metabolites) |
Menthol is classified as a cyclic terpene alcohol and is therapeutically grouped with counterirritants and topical analgesics.