Playmakar Roll on Cool Pain Relief

Description

The product is identified by SPL Code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

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

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, it is essential to seek medical advice promptly. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, care should be taken not to bandage the area tightly, as this could impede circulation and affect the efficacy of the treatment.

Healthcare professionals should advise patients to contact their physician prior to use if they are pregnant or breastfeeding, to ensure safety for both the patient and the child.

Side Effects

Patients should be aware that the product is for external use only and must avoid contact with the eyes. In the event that symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. If swallowed, patients should seek medical advice immediately. It is important to note that the product should not be applied to wounds or damaged skin, and it should not be bandaged tightly.

For patients who are pregnant or breastfeeding, it is recommended to contact a physician prior to use to ensure safety.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Playmakar Roll on Cool Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is recommended to consult a physician prior to 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

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential to evaluate the potential risks and benefits in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

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 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 that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the amount ingested. It is crucial for healthcare providers to monitor the patient closely for any adverse effects that may arise.

Management of overdosage should be guided by the clinical presentation and the physician's recommendations. Supportive care and symptomatic treatment may be necessary, and healthcare professionals should be prepared to provide appropriate interventions based on the patient's condition.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that if the medication is swallowed, they should consult their physician immediately. It is important for patients to understand the potential implications of swallowing the medication and to seek professional guidance without delay.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of three to four times daily for adults and children aged two years and older. For children under two years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should not come into contact with the eyes. Patients are advised to discontinue use and consult a physician if symptoms persist for more than seven days. It is important to keep the product out of reach of children, and if swallowed, medical advice should be sought. The product should not be applied to wounds or damaged skin, and tight bandaging is not recommended. Pregnant or breastfeeding patients should contact their physician before use.

Drug Information (PDF)

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

View product document (PDF)