Menthol

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, specifically in conditions such as arthritis and minor injuries, including sprains, strains, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children over 12 years of age should apply an adequate amount of gel to cover the affected area. On the first day of treatment, the gel should be applied 2 to 3 times within the first hour, with a maximum of six applications throughout the day. For subsequent days, the gel may be applied 3 to 4 times daily, as needed.

The gel is for topical use only. Care should be taken to ensure that the application is thorough and that the affected area is adequately covered.

Contraindications

Use is contraindicated in individuals with a known allergy to any of the product's ingredients.

The product should not be used during pregnancy, while breastfeeding, or in individuals intending to become pregnant due to potential risks to the fetus or infant.

This product is for external use only; therefore, contact with eyes and open wounds must be avoided to prevent adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes and any open wounds. The product should not be used by individuals who have a known allergy to any of its ingredients.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with Poison Control should be established without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only; contact with the eyes and open wounds should be avoided. Patients who are allergic to any of the ingredients should not use this product. It is crucial to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or Poison Control should be contacted.

In terms of precautions, patients are advised to discontinue use and consult a physician if pain persists beyond three days, if a rash or irritation develops, or if the condition worsens or resolves and then returns. These measures are important to ensure the safety and well-being of patients using this product.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients are not specifically addressed in the prescribing information. The product is recommended for use in adults and children over the age of 12. There is no specific dosing information provided for children under 12 years of age.

Healthcare professionals should exercise caution, as the product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with Poison Control is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients, those who are breastfeeding, or women intending to become pregnant should not use this medication. The potential risks associated with the use of this drug during pregnancy have not been established, and its safety profile in this population remains unclear. Therefore, healthcare professionals are advised to counsel patients on the importance of avoiding this medication during pregnancy and while breastfeeding.

Lactation

Lactating mothers are advised against the use of this medication. It is contraindicated in individuals who are breastfeeding or intending to become pregnant. There is no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 available information.

Overdosage

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

Prompt intervention is crucial 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 essential for appropriate management.

Healthcare providers should ensure that patients are monitored closely and that supportive care is administered as necessary. This may include symptomatic treatment and stabilization of vital signs. It is recommended that all relevant information regarding the ingested substance, including the amount and time of ingestion, be communicated to the medical team to facilitate effective treatment.

Nonclinical Toxicology

Do not use this product in individuals who are pregnant, breastfeeding, or intending to become pregnant due to potential teratogenic effects. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the product is intended for external use only. Patients should be instructed to avoid contact with the eyes and any open wounds. It is important to inform patients not to use the product if they have a known allergy to any of its ingredients.

Providers should emphasize the necessity of keeping the product out of reach of children. In the event that the product is swallowed, patients should be instructed to seek medical help or contact Poison Control immediately.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product in a controlled environment, maintaining a temperature range between 68°F and 74°F (20°C to 23°C). The container must remain closed to ensure the integrity of the product.

Additionally, it is important to avoid applying the product in conjunction with a hot pack, as this may affect its efficacy and safety. Proper adherence to these storage and handling guidelines is essential for maintaining product quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)