Pain Relieving Cooling

Description

Pain Relieving Cooling Gel contains Natural Menthol as its active ingredient. The product is manufactured by J.R. Watkins, a company established in 1868. It is designed for temporary relief of discomfort associated with muscles and joints. The net weight of the gel is 3.3 oz (93 g).

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, arthritis, strains, and sprains.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 2 years and older, it is recommended to apply the product liberally to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

After application, it is essential to wash hands thoroughly to prevent accidental contact with other areas or individuals.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may increase the risk of skin burns or other adverse effects.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

Users should refrain from applying the product to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, the use of a heating pad in conjunction with this product is contraindicated, as it may increase the risk of burns or other injuries.

While using this product, it is crucial to avoid contact with sensitive areas, including the eyes, nostrils, and mouth. Bandaging should not be done tightly, as this may impede circulation and lead to further complications.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if a rash or irritation develops.

To ensure safety, this product should 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 is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. It is contraindicated for use on wounds or damaged skin and should not be used in conjunction with a heating pad.

While using this product, patients should avoid contact with the eyes, nostrils, and mouth, and should refrain from tightly bandaging the area of application.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if a rash or irritation develops.

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

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relieving Cooling (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to apply liberally to the painful area, not exceeding 3-4 times daily.

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

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in pregnant individuals. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information regarding the use of this drug in lactating mothers or lactation considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to nursing mothers, as the effects on breastfed infants are not established. It is advisable to monitor breastfed infants for any potential adverse effects if the mother is treated with this medication.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise clinical judgment when prescribing to patients with renal impairment, as specific recommendations are not provided in the available data.

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 event of an overdosage, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt action is crucial in managing potential overdosage situations to mitigate risks 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important for patients to understand that they should stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be cautioned to stop use and seek medical advice if symptoms clear up and then recur within a few days, or if any rash or irritation occurs.

While using this product, patients should be advised to avoid contact with the eyes, nostrils, and mouth. Furthermore, they should not bandage the area tightly when applying the product.

Storage and Handling

The product is supplied with a tamper-evident seal; it should not be used if this seal is not intact. It is essential to store the product away from children to ensure safety. The recommended storage conditions are in a dry, well-ventilated area at room temperature, specifically between 59°F and 77°F. Proper handling and storage are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3-4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)