Mag 5 Pt Cooling Formula Recovery Cream

Description

The product is identified by the SPL code 34089-3. It is presented in a 16-ounce dosage form, specifically labeled as "MAG 5 PT 16.0 OZ." Additionally, it features a "16 OZ. COOLING LABEL."

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.

Limitations of Use: This drug is not intended for the treatment of chronic pain conditions or for use as a substitute for professional medical advice or treatment.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area no more than three times a day, or as directed by a physical or occupational therapist.

For children under 12 years of age, it is advised to consult a physical or occupational therapist for appropriate dosing and administration guidance.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging should be avoided, as it may lead to compromised circulation. Contact with the eyes must be strictly avoided to prevent irritation or injury. Application to wounds or damaged skin is contraindicated due to the risk of exacerbating the condition or causing further harm. Additionally, the use of heating pads or other heating devices in conjunction with this product is not recommended, as it may increase the risk of adverse effects.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

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. Monitoring for these signs is essential to ensure patient safety and effective management of the condition.

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 occur again within a few days.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mag 5 Pt Cooling Formula Recovery Cream (menthol). 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 three 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 prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of MAG 5 PT COOLING FORMULA RECOVERY CREAM during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution and consider the lack of data when prescribing this product to women of childbearing potential. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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 and consider the potential implications of excessive dosing.

It is essential to monitor patients closely for any signs or symptoms that may arise from an overdosage scenario. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement standard supportive measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

As there are no established guidelines for managing overdosage with this particular agent, consultation with a poison control center or a medical toxicologist is recommended for tailored management strategies.

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, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Patients should be informed not to bandage the affected area tightly, as this may lead to complications. Additionally, they should be cautioned to avoid contact with the eyes to prevent irritation or injury. It is essential to instruct patients not to apply the product to wounds or damaged skin, as this could exacerbate the condition or lead to adverse effects. Lastly, healthcare providers should emphasize that the product should not be used in conjunction with heating pads or other heating devices, as this may increase the risk of side effects.

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 at room temperature to maintain its efficacy. Additionally, the product must be protected from light to prevent degradation. Freezing is not permitted, as it may compromise the integrity of the formulation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. Furthermore, it is important to discard the product after opening to avoid any potential contamination or loss of effectiveness.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than three times a day for adults and children aged 12 years and older, or as directed by a physical or occupational therapist. For children under 12 years of age, consultation with a physical or occupational therapist is advised prior to use.

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

Drug Information (PDF)

This file contains official product information for Mag 5 Pt Cooling Formula Recovery Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)