Pain Relieving Cold Therapy

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to apply a liberal amount of gel directly onto the skin over the affected area. This application may be repeated as necessary; however, it is important to limit the total number of applications to no more than four times daily.

For pediatric patients under the age of 2 years, consultation with a physician is recommended prior to use.

Contraindications

The use of this product is contraindicated in the following situations:

Application of the product should not occur on wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, contact with eyes or mucous membranes must be avoided to prevent harmful effects. The product should not be used in conjunction with any medical device or other topical treatments, as this may lead to unpredictable interactions. Furthermore, bandaging or covering the treated area is not recommended, nor should ice or heating pads be applied simultaneously, as these actions may compromise the efficacy and safety of the treatment.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended systemic exposure.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. This precaution is crucial to mitigate potential adverse effects associated with ingestion.

Patients should be instructed to discontinue use and consult their healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur. Additionally, if redness or irritation develops, it is essential to stop the treatment and seek medical advice promptly. Monitoring for these signs is vital to ensure patient safety and effective management of their condition.

Side Effects

Patients should be aware that the product is intended for external use only. It is advised that individuals who are pregnant or breastfeeding consult a healthcare professional prior to use.

In clinical practice, patients are instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Additionally, if redness or irritation develops, patients should stop using the product and consult a doctor.

Drug Interactions

The use of this medication is contraindicated in combination with any other topical treatments. Co-administration with medical devices or any other devices is also not recommended, as it may lead to adverse effects or reduced efficacy.

There are no specific interactions noted with laboratory tests; however, it is advisable to monitor the patient's overall response to treatment and any potential side effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may use the gel by massaging a liberal amount directly onto the skin over the affected area, with a maximum application frequency of 4 times daily as needed. For children under 2 years of age, consultation with a physician is advised prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a healthcare 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 considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 adhere to general principles of management in cases of suspected overdose.

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

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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.

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 in the event of accidental ingestion of the product. Patients should be informed that if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur, they should consult their healthcare provider.

It is important to instruct patients to monitor for any signs of redness or irritation that may develop during the use of the product. Patients should be reminded to use the product only as directed and to avoid bandaging or covering the area being treated. Additionally, they should not apply ice or a heating pad in conjunction with the product.

Healthcare providers should emphasize that the product should not be used with any medical device or any other device, nor should it be combined with any other topical treatments. Patients must be cautioned to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin.

Storage and Handling

The product is supplied in a secure container that must be stored in a cool, dry place. It is essential to ensure that the lid or cap is closed tightly to maintain the integrity of the product. Additionally, the product should be kept away from excessive heat and open flames to prevent any potential degradation or safety hazards.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)