Md80 Clinical Strength Topical Analgesic

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 of muscles and joints associated with conditions such as simple backache, strains, sprains, bruises, and arthritis.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply the medication to the affected area no more than four times daily.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

Application on large areas of the body is not recommended due to the potential for systemic absorption and increased risk of adverse effects. Concurrent use with other ointments, creams, sprays, or liniments may lead to unpredictable interactions and should be avoided. The application of this product in conjunction with a heating pad is contraindicated, as it may enhance absorption and increase the risk of local irritation or burns.

During use, it is essential to avoid contact with the eyes and mucous membranes to prevent irritation. Application to wounds or damaged skin is contraindicated due to the risk of exacerbating the injury or causing infection. Bandaging the area after application is not advised, as it may alter the product's efficacy and increase the risk of adverse reactions. Hand hygiene should be practiced post-application to prevent unintentional transfer of the product.

Warnings and Precautions

For external use only. This product should not be applied to large areas of the body, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Additionally, the use of heating pads in combination with this product is contraindicated.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or experience redness over the affected area.

While using this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and it is important not to bandage the area after application. Patients are also advised to wash their hands thoroughly after use to prevent unintended exposure.

Patients should discontinue use and seek medical advice if the condition worsens or if symptoms persist for more than 7 days. They should also consult a healthcare provider if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

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 a Poison Control Center should be made.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on large areas of the body, in conjunction with other ointments, creams, sprays, or liniments, and should not be used with a heating pad.

Before using this product, patients with sensitive skin or redness over the affected area should consult a healthcare professional. During use, it is important to avoid contact with the eyes or mucous membranes, and the product should not be applied to wounds or damaged skin. Bandaging the area after application is not recommended, and patients should wash their hands thoroughly after use.

Patients are advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, or if excessive skin irritation occurs.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

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

There are no specific interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not necessary in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Md80 Clinical Strength Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 12 years of age may apply the medication to the affected area up to four times daily. For children under 12 years, it is recommended to consult a physician prior to use to ensure appropriate treatment and safety.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human 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 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, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to instruct patients not to apply the product to large areas of the body and to avoid using it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should be informed not to use the product with a heating pad.

Patients should be counseled to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to stop using the product and seek medical advice if symptoms resolve but then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients must be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they bandage the area after application. It is also essential to remind patients to wash their hands thoroughly after using the product.

Finally, healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin or notice redness over the affected area.

Storage and Handling

The product is supplied in a package configuration that includes specific NDC numbers. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial for ensuring the product remains within its specified quality parameters.

Additional Clinical Information

For adults and children over 12 years of age, the medication should be applied to the affected area no more than four times daily. For children under 12 years, it is advised to consult a physician regarding the appropriate use and administration. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Md80 Clinical Strength Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)