Pain Relief

Description

No description information is available for the specified drug.

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.

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

Dosage and Administration

For adults and children aged 12 years and older, the affected area should be cleaned and dried prior to application. The protective film of the gel-patch should be partially peeled back, allowing the exposed side to be applied directly to the site of pain. The remaining film must be carefully removed while ensuring the gel-patch adheres firmly to the skin. The gel-patch may remain in place for a maximum of 8 hours. It is recommended that the gel-patch be applied to the affected areas no more than 3 to 4 times daily.

For children under 12 years of age, consultation with a physician is advised prior to use.

After application, it is important to wash hands thoroughly with cool water to prevent any unintended contact with other areas of the body.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for exacerbating injury and delaying healing. Use is also contraindicated on irritated skin or in cases where excessive irritation develops, as this may lead to further skin damage or adverse reactions. Additionally, tight bandaging or the use of heating pads or devices in conjunction with the product is not recommended, as this may increase the risk of skin irritation or burns.

Contact with eyes or mucous membranes must be avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. It should not be applied to irritated skin or if excessive irritation develops. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad or device, as this may exacerbate adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; or recurrence of symptoms after a brief improvement. Furthermore, if arthritic pain continues for more than 10 days or if redness is observed, medical advice should be sought. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Side Effects

Patients should be aware that the product is for external use only. In the event of adverse reactions, it is advised to stop use and consult a healthcare professional if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms for more than 7 days; or if symptoms clear up and then recur within a few days. Additionally, if arthritic pain persists for more than 10 days or if redness is present, patients should seek medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. For patients aged 12 years and older, the recommended application involves cleaning and drying the affected area, then partially peeling back the protective film to apply the exposed gel-patch to the site of pain. The remaining film should be carefully removed while pressing the gel-patch to the skin, which can be left in place for up to 8 hours. The gel-patch should not be used on affected areas more than 3 to 4 times daily.

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

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney 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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals should refer to established protocols and consult relevant toxicology resources.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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 accidentally ingested. It is important to instruct patients not to apply the product to wounds or damaged skin, and to avoid application on irritated skin or if excessive irritation develops.

Patients should be informed not to bandage the area tightly or use the product in conjunction with a heating pad or device. They should use the product only as directed and be cautioned to avoid contact with the eyes and mucous membranes.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience pain, swelling, or blistering of the skin. Additionally, patients should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be informed to stop use and consult a doctor if arthritic pain persists for more than 10 days or if redness is present.

Finally, it is essential to remind patients who are pregnant or breastfeeding to consult a health professional before using the product.

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 a temperature range of 68-77℉ (20-25℃). The storage location should be a cool, dry place, ensuring that the product is kept away from direct sunlight to maintain its integrity and efficacy. Proper handling and adherence to these storage conditions are crucial for optimal product performance.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, the affected area should be cleaned and dried before applying the gel-patch. The protective film should be partially peeled back to expose the gel-patch, which is then pressed onto the site of pain. The remaining film is to be carefully removed while ensuring the gel-patch adheres to the skin, and it may be left in place for up to 8 hours. The gel-patch should not be used on affected areas more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)