Menthol

Description

Menthol 4% Cream is a topical formulation containing menthol as the active ingredient. The product is packaged in a 120-gram container. The National Drug Code (NDC) for this formulation is 50488-1040-1.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication externally to the affected area up to 3 to 4 times daily. The application should be performed with clean hands, ensuring that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects. Application to wounds or damaged skin is contraindicated due to the potential for increased sensitivity and complications. Additionally, the product should not be bandaged, as this may alter its intended effects and increase the risk of local reactions.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes when using this product. It is crucial to instruct patients not to apply the product in large quantities, especially over raw surfaces or blistered areas, and to refrain from using it on wounds or damaged skin. Additionally, patients should be cautioned against bandaging the area after application.

Patients must be informed to discontinue use and seek medical advice if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after they have cleared, or the onset or increase of redness, irritation, swelling, pain, or other adverse symptoms.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from using the product in large quantities, particularly over raw surfaces or blistered areas. The product should not be applied to wounds or damaged skin, and it is advised not to bandage the area after application.

In clinical practice, patients are advised to stop use and consult a doctor if an allergic reaction occurs, if the condition worsens or does not improve within 7 days, or if symptoms clear up and then return within a few days. Additionally, patients should seek medical attention if they experience increased redness, irritation, swelling, pain, or other symptoms.

This product should be kept out of reach of children. In the event of ingestion, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to four times a day. For children under 2 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of Menthol 4% Cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of this treatment.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of Menthol Cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Menthol Cream in breast milk or its effects on breastfed infants. Healthcare professionals may consider this lack of specific data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any allergic reactions, if their condition worsens or does not improve within 7 days, if symptoms resolve and then return within a few days, or if they notice any increase in redness, irritation, swelling, pain, or other symptoms.

While using this product, patients should be cautioned to avoid contact with the eyes. They should not use the product in large quantities, especially over raw surfaces or blistered areas, and it should not be applied to wounds or damaged skin. Additionally, patients should be informed not to bandage the area where the product is applied.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20-25°C (68-77°F), with permissible excursions between 15-30°C (59-86°F) in accordance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of up to four times a day for adults and children aged 2 years and older. For children under 2 years, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Menthol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)