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.

Cough Relief

• Temporarily relieves cough due to cold or inhaled irritants.

• Temporarily relieves occasional minor irritation and pain associated with sore throat or sore mouth.

Pain Relief

This drug is also indicated for the temporary relief of minor aches and pains of muscles and joints associated with:

• Arthritis

• Simple backache

• Strains

• Sprains

• Bruises

• Cramps

Special Conditions

• For adults and children over 12 years, apply to the affected area no more than 3 times daily and do not wear the patch for more than 8 hours.

• Consult a doctor for children under 12 years of age.

Limitations of Use

• No teratogenic or nonteratogenic effects have been 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 recommended prior to use.

For topical applications, adults and children 2 years and older may apply the product to the affected area not more than 3 to 4 times daily. Children under 2 years 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 patch to the skin, 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. Children under 12 years should consult a physician before use.

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

Contraindications

Use of the products is contraindicated in the following situations:

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

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

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

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

• 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 persistent or chronic cough, such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm.

• If swallowed, seek medical help or contact a Poison Control Center immediately.

Consult a healthcare professional if conditions worsen or if symptoms clear up and recur within a few days.

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 symptoms persist for more than 2 days, consult a doctor promptly. If sore mouth symptoms do not improve within 7 days, see a dentist or doctor.

Cough Warnings Cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache should prompt a consultation with a doctor, as these may be signs of a serious condition.

General Precautions

• For external use only.

• Avoid contact with eyes and mucous membranes.

• Do not apply to wounds, damaged, or irritated 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, seek medical help or contact a Poison Control Center immediately.

Stop Use and Consult a 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 then recur within a few days.

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

Emergency Medical Help In case of accidental ingestion, get medical help or contact a Poison Control Center immediately. If severe skin reactions occur, discontinue use and seek medical advice.

Laboratory Tests Consult a doctor before use if you have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus).

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 and warnings associated with these 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 multiple cough drop products, including those from brands such as Halls, Equate, and Freegells.

• Consult a Doctor: If cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, this may signal a serious condition requiring medical attention.

Common Adverse Reactions

• Skin Reactions: Patients may experience skin irritation, redness, or burning sensations at the application site. If these symptoms persist for more than 7 days or worsen, patients should discontinue use and consult a doctor.

• Transient Burning Sensation: Some products may cause a transient burning sensation upon application, which generally subsides over time. If the burning sensation is severe or persistent, patients should stop using the product.

Warnings for Specific Conditions

• External Use Only: All products are for external use only. Patients should avoid contact with eyes, mucous membranes, and broken or damaged skin.

• Do Not Bandage Tightly: Patients are advised not to bandage the area tightly or use heating pads in conjunction with these products, as this may exacerbate irritation or cause burns.

• Pregnancy and Breastfeeding: Pregnant or breastfeeding women should consult a healthcare professional before using these products.

Additional Considerations

• Flammability: Many topical analgesics are flammable and should be kept away from heat or open flames.

• Keep Out of Reach of Children: All products should be stored out of reach of children. In case of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Summary of Stop Use Recommendations

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

• Condition worsens or symptoms persist for more than 7 days.

• Redness, irritation, or excessive skin reactions develop.

• Symptoms clear up and then recur within a few days.

This summary highlights the importance of monitoring for adverse reactions and seeking medical advice when necessary.

Drug Interactions

No specific drug interactions have been identified for the following products:

• Equate Sf Menthol Cough Drops (Lozenge)

• Biofreeze (Spray)

• Premier Value (Lozenge)

• Smooth Gator Head-Ezz Analgesic (Cream)

• Fortify (Oil)

• Bae Sciences Menthol Muscle Rub (Lotion)

• Miracle Foot Repair (Cream)

• Discount Drug Mart (Lozenge)

• Cough Drops (Pastille)

• Healthwise Pain Relief (Spray)

• Medi First Plus Cherry Cough Drops, Medi-First Cherry Cough Drops, Medique Medikoff Drops (Lozenge)

• Green Guard Cough Drop Relief (Lozenge)

• Halls (Lozenge)

• Medfreeze Naturally Cool Pain Relief (Liquid)

• Menthol (Paste)

• 4jointz (Cream)

• Mgc Health Cough Drops (Lozenge)

• Exchange Select Cough Drops (Lozenge)

• Chinese Red Tiger Plaster (Patch) - Note: Do not use with other ointments, creams, sprays, or liniments.

• Cold Therapy (Gel) - Note: Do not use with other ointments, creams, sprays, or liniments.

• Budpack (Gel)

• Walgreens Medicated Foot Powder (Powder)

• Gutong Tiegao Pain Relieving (Plaster)

• Ez Massager 2 (Gel)

• Lilas Period (Patch)

• Healthwise Overnight Menthol Patch (Patch) - Note: Do not use at the same time as other topical analgesics.

• Pain Relieving Cold Therapy (Gel) - Note: Do not combine with any other topical treatments or use with any medical device.

• Mckesson Sugar Free Cough Suppressant Oral Anesthetic (Lozenge)

• Zhuanggu Gao Pain Relieving (Plaster)

• Recovery (Ointment)

• Caring Mills Menthol 4% Roll-on (Gel)

• Mgc Health (Tablet, Chewable, Extended Release)

• Biofreeze Overnight Roll-on (Gel)

• Theracare Roll-on Menthol 4% Pain Relief (Gel)

• Sugarloaf Organics Menthol Revive (Cream)

• Eco Lips Menthol Medicated Lip Balm (Stick)

• Control Menstrual Cramp Relief (Cream)

Additionally, no drug and laboratory test interactions have been reported for these products.

Pediatric Use

Pediatric patients may require special considerations when using various medications. The following summarizes the pediatric use information across multiple products:

Age-Specific Recommendations

• Children under 2 years:

  • Consult a physician before use for all products.

• Children 2 years and older:

  • Many products can be applied or administered, but specific instructions vary:

    • Topical applications (creams, gels, sprays): Generally safe for children 2 years and older, with a maximum application of 3 to 4 times daily.

    • Lozenges: Typically recommended for children 2 years and older, with specific instructions to dissolve slowly in the mouth and repeat every 2 hours as needed.

• Children under 5 years:

  • Ask a doctor before use for lozenges and other medications.

• Children 5 years and older:

  • Generally, medications can be used as directed for adults, with specific dosages often mirroring those for adults.

• Children under 12 years:

  • Many products advise consulting a physician before use, particularly for topical analgesics and cough drops.

Dosage and Administration

• Lozenges:

  • For children 2 years and older, dissolve slowly in the mouth, repeating every 2 hours as needed. Children under 5 years should consult a doctor before use.

• Topical Products:

  • Apply to the affected area not more than 3 to 4 times daily for children 2 years and older. For children under 2 years, consult a physician.

Safety Precautions

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

• Specific warnings apply to children under 12 years for certain products, advising against use unless directed by a physician.

Summary

Pediatric patients should be carefully monitored when using medications, particularly those under 12 years of age. Consultation with a healthcare provider is recommended for children under 5 years and for all children when using topical analgesics or cough drops.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the drug inserts for the products reviewed. Therefore, healthcare professionals should exercise caution when prescribing these medications to geriatric patients, as the absence of data may indicate a lack of established safety or efficacy in this population. Monitoring for potential adverse effects and adjusting dosages as necessary based on individual patient response is recommended.

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 precautions are advised:

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

• Specific Contraindications: Certain products explicitly advise against use during pregnancy. For example, some formulations of pain relief products and cough drops indicate that they should not be used if pregnant or breastfeeding.

• Safety Concerns: The safety of many ingredients, particularly menthol, during pregnancy has not been fully established. Pregnant patients should be cautious and discuss potential risks with their healthcare provider.

• Dosage Modifications: There are no specific dosage modifications provided for pregnant individuals across the majority of products. Consultation with a healthcare provider is essential for personalized guidance.

• Fetal Impact: Some products may pose potential risks to the fetus, and further studies are needed to determine their safety. Pregnant patients should only use these products if clearly needed and after discussing with a healthcare provider.

In summary, the overarching recommendation for all products is to consult a healthcare professional before use during pregnancy or breastfeeding to ensure safety and appropriateness.

Lactation

Lactating mothers are advised to consult a healthcare professional before using various products, particularly those labeled for pain relief or cough suppression. Many products, including lozenges and topical treatments, do not provide specific information regarding their safety during lactation or the potential for excretion in breast milk.

For instance, some products explicitly state that nursing mothers should seek medical advice prior to use, as the effects on breastfed infants are not well studied. Caution is particularly emphasized for products like Mgc Health Cough Drops, which indicate a potential for excretion in breast milk and recommend consulting a doctor due to the unknown effects on nursing infants.

While several labels lack specific warnings or recommendations for nursing mothers, it remains prudent for lactating individuals to approach the use of any medication or topical treatment with caution. The absence of data does not imply safety, and healthcare professionals can provide guidance tailored to individual circumstances.

Renal Impairment

Patients with renal impairment may require careful consideration regarding the use of certain medications. For those with reduced kidney function, dosage adjustments may be necessary to avoid potential toxicity. It is recommended that renal function tests be conducted regularly to monitor the patient's condition.

Specifically, for patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered. Special monitoring is advised for patients with significant renal impairment to ensure safety and efficacy of the treatment.

In summary, healthcare providers should assess renal function prior to initiating therapy and adjust dosages accordingly for patients with renal impairment to mitigate risks associated with medication use.

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 tests may be advisable to ensure patient safety, although specific parameters are not outlined 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 general recommendations include monitoring for any adverse reactions and providing supportive care as needed.

For products such as Biofreeze, if accidentally ingested, individuals should get medical help or contact a Poison Control Center right away. Similarly, for products like Cannarelief and various menthol-based creams and gels, immediate medical assistance is advised if swallowed.

Specific products, including various cough drops and topical analgesics, also emphasize the importance of contacting a healthcare professional or poison control center in the event of accidental ingestion. This includes items like the Menthol Cough Drops, which instruct users to seek help if an overdose occurs.

In summary, the recommended action for any suspected overdose is to obtain medical assistance promptly, as timely intervention can mitigate potential health risks associated with the ingestion of these products.

Nonclinical Toxicology

Teratogenic Effects

No teratogenic effects were observed in animal studies for certain products, including those labeled as "Cbd Menthol Pain Relief" and "Pain Relief." However, some products explicitly advise against use during pregnancy or breastfeeding, such as "Fortify," "Pain Relief," and "Cvs Pain Relief," recommending consultation with a health professional.

Non-Teratogenic Effects

Animal studies did not indicate any increase in fetal malformations for products like "Cbd Menthol Pain Relief" and "Pain Relief." Nonetheless, several products lack specific information regarding non-teratogenic effects.

Nonclinical Toxicology

The nonclinical toxicology sections for many products do not provide relevant information. Notably, products such as "Cbd Menthol Pain Relief" and "Pain Relief" indicate that no adverse developmental outcomes were observed in animal studies. However, the majority of labels reviewed do not contain any nonclinical toxicology data.

Animal Pharmacology and Toxicology

Animal pharmacology and toxicology data are generally absent across the reviewed products. Where available, studies have not shown any significant adverse effects. For instance, "Cbd Menthol Pain Relief" and "Pain Relief" report no adverse developmental outcomes in animal studies.

Storage and Handling

Equate Honey Lemon Cough Drops, Equate Sf Menthol Cough Drops, and various other cough drop products are supplied in lozenge form. It is important to note that these products should not be used if the bag is torn or open.

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

Saint is supplied as a liquid and should be stored strictly away from light and kept at low temperatures. Cannarelief products, available in salve form, should be stored at 68-77°F and protected from direct sunlight.

For patches, such as the Signature Care Medicated Cold and Hot Patch and various menthol patches, storage should be at room temperature, not exceeding 86°F (30°C). They should be kept away from excessive moisture and direct sunlight.

Lozenges, including those from Premier Value, Mgc Health, and Quality Choice, generally do not have specific storage instructions but should be kept in a cool, dry place. Some products, like the Herbal Cough Drops and Natural Honey Herb Cough Suppressant Throat Drops, should also be stored in a dry place.

Gel and cream products, such as Pain Relief Gel and various topical analgesics, should be stored in a cool, dry place, with lids tightly closed. Many of these products specify a storage temperature range of 20-25°C (68-77°F) and should be protected from light and excessive heat.

In summary, products should be stored according to their specific requirements, with a focus on maintaining appropriate temperature ranges, protecting from light and moisture, and ensuring that containers are tightly closed to preserve product integrity.