Medterra Pain Relief Menthol Roll-on

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to apply the cream to the affected areas once daily, or as needed, based on the patient's condition. It is recommended to consult with a physician to determine the optimal usage tailored to individual patient needs.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes or mucous membranes should be avoided due to the potential for irritation. Application to wounds or damaged skin is contraindicated to prevent adverse reactions. The product should not be used concurrently with other ointments, creams, sprays, or liniments, as this may lead to unpredictable effects. Application to irritated skin or in cases where excessive irritation develops is also contraindicated. Bandaging the area after application is not recommended, as it may exacerbate irritation. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse effects.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin is contraindicated, and if excessive irritation develops, use should be discontinued. Bandaging the area after application is not recommended.

Healthcare professionals should advise patients to wash their hands thoroughly with cool water after using the product. Additionally, it should not be used in combination with heating pads or devices, and proper storage in a cool, dry place is essential to maintain product integrity.

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

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, individuals with sensitive skin should seek medical advice before using this product.

Drug Interactions

Co-administration of this product with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this product is also not recommended, as it may lead to adverse effects.

There are no specific interactions identified with laboratory tests associated with this product. Therefore, no adjustments or special monitoring are required in this context.

Packaging & NDC

Below are the non-prescription pack sizes of Medterra Pain Relief Menthol Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, it is essential for healthcare professionals to remain vigilant and exercise caution when administering the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any potential symptoms that may arise, although no specific symptoms have been documented in the available literature.

Management of an overdosage situation should involve standard supportive care measures. This may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient’s safety. In cases where the overdosage is suspected, immediate consultation with a poison control center or a medical toxicologist is advised to determine the most appropriate course of action.

Healthcare professionals are encouraged to report any observed adverse effects or overdosage incidents to the relevant regulatory authorities to enhance the understanding of the medication's safety profile.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

When using this product, it is important to avoid contact with the eyes and mucous membranes. Patients should be cautioned against applying the product to wounds or damaged skin, and they should not use it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should refrain from applying the product to irritated skin or if excessive irritation develops, and they should not bandage the area after application. It is recommended that patients wash their hands with cool water after use and avoid using the product with heating pads or devices. Patients should also be informed to store the product in a cool, dry place.

Furthermore, healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place to maintain its efficacy. Care should be taken to keep the product away from excessive heat and open flame, as these conditions may compromise its quality. Proper storage conditions are crucial for ensuring the product remains safe and effective for use.

Additional Clinical Information

Patients should apply the cream to affected areas daily as needed, with consultation from a physician recommended for optimal usage. The cream is for external use only and should not come into contact with the eyes or mucous membranes. It is contraindicated for application on wounds, damaged, or irritated skin, and should not be used in conjunction with other ointments, creams, sprays, or liniments. Bandaging the area after application is not advised, and hands should be washed with cool water post-application.

Patients are cautioned against using the cream with heating pads or devices and should store it in a cool, dry place. Those who are pregnant or breastfeeding should seek advice from a health professional before use. The product must be kept out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)