Menthol

Uses and Indications

This drug is indicated for the temporary relief of cough as may occur with a cold, and for the temporary relief of occasional minor irritation and sore throat. It is suitable for adults and children 12 years of age and older, with specific instructions to consult a doctor for children under 12 years.

For the relief of minor aches and pains, this drug is indicated for use in conditions such as arthritis, simple backache, muscle strains, sprains, bruises, and cramps. It provides temporary relief from discomfort associated with these conditions.

Cough Relief

• Temporarily relieves cough due to:

  • Cold

  • Inhaled irritants

• Temporarily relieves occasional minor irritation and pain due to:

  • Sore throat

  • Sore mouth

Pain Relief

• Temporarily relieves minor aches and pains associated with:

  • Arthritis

  • Simple backache

  • Muscle strains

  • Sprains

  • Bruises

  • Cramps

Limitations of Use

• For children under 12 years of age, consult a doctor before use.

• Do not exceed the recommended application frequency or duration for patches and topical applications.

This drug does not have any known teratogenic or nonteratogenic effects mentioned in the provided information.

Dosage and Administration

Adults and children 5 years and older are instructed to dissolve 1 lozenge slowly in the mouth, repeating every 2 hours as needed or as directed by a healthcare professional. For children under 5 years, consultation with a doctor is advised.

For topical applications, adults and children 2 years and older should apply the product to the affected area not more than 3 to 4 times daily. Children under 2 years of age should consult a physician before use. Specific instructions include cleaning and drying the affected area prior to application, and in some cases, massaging the product into the skin until fully absorbed.

For patches, adults and children 12 years and older should clean and dry the affected area, apply the sticky side of the patch, and may repeat as necessary, but not more than 3 to 4 times daily. Each patch should not be left on for more than 8 hours, and children under 12 years should consult a physician.

In all cases, if the product comes into contact with hands, it is recommended to wash with soap and water.

Contraindications

Use of these products is contraindicated in the following situations:

• Do not apply to wounds, damaged, broken, or irritated skin.

• Do not use with heating pads or other heating devices.

• Do not bandage tightly.

• Avoid contact with eyes and mucous membranes.

• Do not use if allergic to any ingredient in the product.

• Do not use if pregnant or breastfeeding without consulting a healthcare professional.

• Do not use on infants or children under 12 years of age with arthritis-like conditions.

• Do not use if you have high blood pressure or are epileptic.

• Do not use if excessive skin irritation develops or if symptoms persist for more than 7 days.

• Do not use if the product's appearance has changed or if the tamper-evident seal is broken.

• Do not use if you have known hypersensitivities to the product or its ingredients.

• Do not use if swallowed; seek medical help or contact a Poison Control Center immediately.

Consult a healthcare professional if symptoms worsen or if there are signs of a serious condition, such as persistent cough, fever, rash, or severe sore throat.

Warnings and Precautions

Sore Throat Warnings Severe or persistent sore throat, especially if accompanied by fever, headache, rash, swelling, nausea, or vomiting, may indicate a serious condition. If sore throat persists for more than 2 days, consult a doctor promptly. If sore mouth symptoms do not improve within 7 days, see a dentist or doctor. These symptoms may be serious.

Cough Warnings Consult a doctor if cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.

General Precautions

• For external use only.

• Avoid contact with eyes and mucous membranes.

• Do not apply to wounds or damaged skin.

• Do not bandage tightly or use with heating pads or devices.

• If pregnant or breastfeeding, consult a health professional before use.

• Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Stop Use and Call Your Doctor

• If condition worsens or symptoms persist for more than 7 days.

• If redness, irritation, or excessive skin discomfort develops.

• If symptoms clear up and occur again within a few days.

• If you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Get Emergency Medical Help In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Side Effects

Patients using various topical analgesics and cough drops should be aware of potential adverse reactions, which can vary in severity and frequency. The following summarizes the adverse reactions reported across multiple products:

Serious Adverse Reactions

• Sore Throat Warning: Severe or persistent sore throat accompanied by high fever, headache, rash, swelling, nausea, or vomiting may indicate a serious condition. Patients should consult a doctor promptly if these symptoms occur. This warning applies to several cough drop products, including those from Equate, Halls, and Freegells.

• Skin Reactions: Patients may experience severe skin reactions such as pain, swelling, blistering, or excessive irritation. If these symptoms occur, patients should discontinue use and consult a doctor. This warning is noted for various topical products, including Biofreeze and Dch Cooling Pain Relief.

Common Adverse Reactions

• Cough and Sore Throat: If cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, patients should stop use and consult a doctor. This is a common warning across multiple cough drop labels.

• Skin Irritation: Redness, irritation, or pain that persists or worsens after using topical products should prompt patients to stop use and seek medical advice. This is highlighted in warnings for products like Biofreeze, Pain Relief Gel, and various patches.

Additional Considerations

• Pregnancy and Breastfeeding: Patients who are pregnant or breastfeeding should consult a healthcare professional before using these products, as some may not be suitable during these periods.

• Sensitive Skin: Individuals with sensitive skin should exercise caution and consult a doctor before use, especially if they have a history of allergic reactions to topical treatments.

General Warnings

• External Use Only: All products are for external use only and should not be applied to open wounds or damaged skin. Patients should avoid contact with eyes and mucous membranes.

• Flammability: Many products are flammable and should be kept away from heat or open flame.

Summary of Stop Use Recommendations

Patients should stop using the product and consult a doctor if:

• Symptoms worsen or persist for more than 7 days.

• Skin irritation or redness develops.

• Severe burning sensation occurs upon application.

This summary provides an overview of the potential adverse reactions associated with topical analgesics and cough drops, emphasizing the importance of monitoring symptoms and consulting healthcare professionals as needed.

Drug Interactions

No specific drug interactions have been reported for the following products across various formulations, including lozenges, gels, creams, sprays, and patches:

• Cough Drops: Multiple brands, including Equate, Premier Value, Mgc Health, and others, have no documented drug interactions. This includes various flavors such as honey lemon, menthol, cherry, and sugar-free options.

• Topical Analgesics: Products such as Biofreeze, Careall Muscle and Joint Gel, and various pain relief creams and gels report no drug interactions. This category encompasses a wide range of formulations, including sprays, gels, creams, and patches.

• Pain Relief Products: Various pain relief formulations, including those from brands like Healthwise, Walgreens, and Gold Bond, have not indicated any drug interactions.

• Other Products: Items such as throat lozenges and medicated patches also show no reported drug interactions.

Additionally, some products have specific warnings regarding concurrent use with other topical treatments or medical devices. For instance, the Cold Therapy gel and Pain Relieving Cold Therapy gel advise against combining with other topical treatments or using with medical devices.

Overall, the majority of the products reviewed do not present any known drug interactions, making them generally safe for use without concern for interactions with other medications.

Pediatric Use

Pediatric patients under 5 years of age should consult a doctor before using cough drops, lozenges, or similar products. For children aged 5 years and older, the recommended dosage is to dissolve one lozenge slowly in the mouth every 2 hours as needed or as directed by a healthcare provider.

Age-Specific Recommendations:

• Children under 2 years: Consult a doctor before use for any topical products, gels, or sprays.

• Children 2 years and older: Many topical products can be applied to the affected area not more than 3 to 4 times daily, but specific instructions should be followed based on the product.

• Children under 12 years: Consult a physician before using patches, creams, or gels, especially for conditions like arthritis.

Safety Precautions:

• All products should be kept out of reach of children. In case of accidental ingestion, medical help should be sought immediately or contact a Poison Control Center.

• For cough drops and lozenges, choking hazards exist for children under 4 years; supervision is advised during use.

General Dosage Information:

• Cough Drops/Lozenges:

  • Children under 5 years: Ask a doctor.

  • Children 5 years and older: Dissolve 1 lozenge slowly in the mouth; repeat every 2 hours as needed.

• Topical Products:

  • Children under 2 years: Consult a doctor.

  • Children 2 years and older: Apply to the affected area not more than 3 to 4 times daily.

Special Considerations:

• Products intended for children under 12 years with arthritis-like conditions should not be used without consulting a physician.

• Pediatric use has not been specifically addressed for some products; healthcare providers should be consulted for guidance.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the reviewed products. Therefore, healthcare professionals should exercise caution when administering these products to geriatric patients, as the lack of data may indicate a need for careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and potential comorbidities of elderly patients before recommending these products.

Pregnancy

Pregnant patients should consult a healthcare professional before using any of the products listed, as many do not have established safety profiles during pregnancy. The following considerations apply:

• General Precautions: For most products, including various cough drops, gels, creams, and patches, it is advised that pregnant or breastfeeding individuals seek medical advice prior to use. This includes products such as menthol cough drops, topical analgesics, and pain relief creams.

• Risk to Fetus: Several products have not been evaluated for safety in pregnancy, and potential risks to the fetus cannot be ruled out. For instance, topical analgesics and menthol-containing products may pose unknown risks, and caution is advised.

• Contraindications: Some products explicitly state not to use if pregnant or breastfeeding. For example, certain pain relief patches and gels recommend against use during pregnancy due to insufficient safety data.

• Dosage Modifications: There are generally no specific dosage modifications provided for pregnant individuals across the various products. It is essential for healthcare providers to assess the risks and benefits on a case-by-case basis.

• Special Precautions: Pregnant patients should only use these products if clearly needed and after discussing potential risks with a healthcare provider. This is particularly important for products that have not been studied in pregnant women or lack specific safety information.

In summary, the use of these products during pregnancy should be approached with caution, and healthcare professionals should be consulted to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional before using various products, particularly those labeled for cough relief, pain relief, or topical applications. Many products indicate a potential for excretion in breast milk, and the effects on breastfed infants are often not well studied, necessitating caution.

For instance, several cough drops and topical analgesics suggest that nursing mothers should seek medical advice prior to use due to the possibility of excretion in breast milk and the unknown effects on nursing infants. Specific products, such as those from the Premier Value and Mgc Health lines, explicitly state that nursing mothers should consult a doctor, highlighting the need for careful consideration of risks versus benefits.

While some products do not provide specific warnings or recommendations regarding nursing mothers or lactation, it is prudent for lactating mothers to err on the side of caution. The safety of many topical treatments and cough drops during lactation has not been established, and the lack of information regarding excretion in breast milk or associated risks to infants underscores the importance of professional guidance.

In summary, lactating mothers should prioritize consultation with healthcare providers when considering the use of any medication or topical treatment, especially those with potential implications for breast milk and infant health.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain medications. For some products, dosage adjustments may be necessary based on the severity of renal function decline.

Regular monitoring of renal function is recommended for patients with known kidney problems, particularly those with a creatinine clearance of less than 30 mL/min. In such cases, a reduced dose may be warranted to avoid potential toxicity. Special monitoring is advised for patients with significant renal impairment to ensure safety and efficacy.

It is essential for healthcare providers to assess renal function prior to initiating therapy and to conduct regular renal function tests throughout the treatment course. This approach helps to tailor the medication regimen appropriately for patients with compromised kidney function.

Hepatic Impairment

Patients with hepatic impairment may not require specific dosage adjustments, special monitoring, or precautions when using the products listed. The available inserts for these products do not provide any information regarding the effects of hepatic impairment on their pharmacokinetics or safety profiles. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing these products to patients with liver conditions. Regular monitoring of liver function may be advisable, but specific parameters or lab values are not indicated in the product information.

Overdosage

In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center immediately. Symptoms of overdose may vary depending on the specific product ingested, but common recommendations include monitoring for any adverse reactions and providing supportive care as needed.

For products that are ingested accidentally, such as various cough drops, gels, creams, and sprays, immediate medical assistance is advised. Specific products, including Biofreeze, various menthol creams, and pain relief gels, explicitly instruct users to contact a Poison Control Center if swallowed.

In instances where ingestion occurs, it is recommended to keep the affected individual calm and avoid inducing vomiting unless directed by a medical professional. For topical products, if ingested, the same protocol applies: seek medical attention promptly.

Overall, the emphasis is on immediate action and professional guidance in the event of an overdose, as timely intervention can significantly impact outcomes.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were observed in animal studies for the majority of products reviewed. However, specific products indicate that if pregnant or breastfeeding, individuals should consult a health professional before use. This caution is noted for products such as Freegells Cough Drops Menthol Honey Lemon and Cough Drops Dollar General Honey Lemon, among others.

Non-Teratogenic Effects

No significant non-teratogenic effects were reported across the reviewed products. In instances where effects were mentioned, they were not specified in detail.

Nonclinical Toxicology Section

The nonclinical toxicology sections for the majority of products do not provide specific information. For those that do, details are often limited or not applicable.

Animal Pharmacology and Toxicology

Animal studies generally did not show any adverse developmental outcomes or significant pharmacological effects. Notably, products like Ez Massager 2 and Cbd Menthol Pain Relief reported no increase in fetal malformations in animal studies. However, comprehensive pharmacological and toxicological data were not provided for most products, indicating a lack of detailed animal studies or findings.

Storage and Handling

Equate Honey Lemon Cough Drops and Equate Sf Menthol Cough Drops are supplied as lozenges. These products should not be used if the bag is torn or open.

Magsoothium CBD Body is supplied as a spray. It should be stored at room temperature, protected from light, and kept tightly closed. Discard after opening.

Biofreeze and Biofreeze Professional are available in spray and aerosol forms. Biofreeze should be stored in a cool, dry place, away from excessive heat or open flame, and not above 120°F. Biofreeze Professional should be stored at 20-25°C (68-77°F) in a cool, dry place away from direct sunlight.

Saint is supplied as a liquid and should be stored strictly away from light and at low temperatures.

Careall Muscle and Joint is supplied as a gel and should be stored at room temperature, kept out of reach of children, and used for external application only without tight bandaging.

Cannarelief products, including 1000mg and 2000mg salves, should be stored at 68-77°F (20-25°C) and protected from direct sunlight.

Healing Hand Cream 2000mg is supplied as a salve and should be stored at 68-77°F (20-25°C) while avoiding direct sunlight.

Menthol patches, including Kroger Hot and Cold Medicated Patch and Signature Care Medicated Cold and Hot Patch, should be stored at room temperature, not exceeding 86°F (30°C). Reseal the pouch after opening and discard after single use.

Various cough drops, including those from Premier Value, Mgc Health, and others, are supplied as lozenges and should be stored at room temperature, away from excessive heat or sunlight. They should not be used if the bag is torn or open.

Pain relief products, such as Biofreeze, Healthwise Pain Relief, and various gels and creams, should be stored at room temperature, typically between 20-25°C (68-77°F), and kept tightly closed. Many of these products should be protected from light and excessive heat, and some require discarding after opening.

In summary, products should be stored in a cool, dry place, away from direct sunlight and excessive heat, with containers tightly closed. Specific handling instructions include discarding products after opening or if seals are broken.