Magnificent Menthol Cooling Pain Cream

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 deep muscle therapy treatments.

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

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area no more than 10 times per day, or as directed by a physical or occupational therapist. It is essential to follow the specific guidance provided by the healthcare professional regarding the frequency and technique of application to ensure optimal therapeutic outcomes.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging should be avoided to prevent compromised circulation.

• Contact with the eyes must be avoided to prevent irritation or injury.

• Application to wounds or damaged skin is contraindicated due to the risk of adverse effects.

• Concurrent use with heating pads or other heating devices is not recommended, as it may lead to increased absorption and potential toxicity.

Warnings and Precautions

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

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to avoid tight bandaging of the treated area to prevent complications. Additionally, contact with the eyes must be strictly avoided to prevent irritation or injury.

The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Furthermore, the use of heating pads or other heating devices in conjunction with this product is contraindicated, as it may increase the risk of skin irritation or burns.

Side Effects

For external use only. Patients should discontinue 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 within a few days.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Magnificent Menthol Cooling Pain Cream (menthol topical analgesic). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 10 times a day, or as directed by their physical or occupational therapist. For children under 12 years of age, it is advised to consult a physical or occupational therapist for appropriate guidance on use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of MAGNIFICENT MENTHOL COOLING PAIN CREAM during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known risks, dosage modifications, or special precautions outlined for its use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. However, it is advisable to monitor breastfed infants for any potential effects, as no data on excretion in breast milk or effects on nursing infants are available.

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, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to dosing recommendations are crucial to minimize the risk of overdosage and ensure patient safety.

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 compound in these areas.

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 swallowed. It is important to instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, patients should be informed of specific precautions. They should not bandage the area tightly and must avoid contact with the eyes. Additionally, patients should be cautioned against applying the product to wounds or damaged skin. It is also essential to advise patients not to use the product in conjunction with heating pads or other heating devices to prevent potential complications.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. The container must be kept tightly closed to maintain the integrity of the product. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

Patients aged 12 years and older are instructed to apply the medication to the affected area no more than 10 times a day, or as directed by their physical or occupational therapist. For children under 12 years of age, it is recommended to consult a physical or occupational therapist for guidance on administration.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)