Gel Cooling Pain Relief

Description

swan® is a roll-on cooling pain relief formulation designed to alleviate discomfort associated with arthritis, sore muscles, joints, and back pain. The product features a pain-relieving gel that incorporates soothing menthol as its active ingredient. It is presented in a 2.5 FL OZ (74 mL) container and is characterized by a diminishing scent. This formulation is comparable to Biofreeze® Cool the Pain® Colorless Roll-On Menthol Pain Relieving Gel.

Uses and Indications

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

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center without delay.

Patients should discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and intervention.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Gel Cooling Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

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

The product has not been evaluated for safety in pregnancy, and therefore, the safety of menthol during this period has not been established. Pregnant patients or those planning to become pregnant are advised to consult a healthcare provider prior to use. There are no specific contraindications listed for the use of this product during pregnancy; however, due to the lack of safety data, caution is warranted. No specific dosage modifications for pregnant individuals are provided. Healthcare professionals should consider these factors when advising women of childbearing potential regarding the use of this product.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the substance involved, the amount ingested, and the time of exposure, is crucial for effective treatment 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 for patients to understand that they should 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 instructed to avoid contact with the eyes. They should also be cautioned against applying the product to wounds or damaged skin, and they should not bandage the area tightly after application. These precautions are essential to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 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 prior to 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 Gel Cooling Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)