Salonpas Pain Relief

Description

This topical analgesic contains 3% menthol and 10% methyl salicylate. It is an FDA-approved non-prescription pain-relieving patch, with effectiveness confirmed in clinical trials. Each package contains nine large patches, each measuring 3 15/16" x 5 1/2" (10 cm x 14 cm). The packaging is not child-resistant.

Uses and Indications

This drug is indicated for the temporary relief of mild to moderate aches and pains of muscles and joints associated with strains, sprains, simple backache, arthritis, and bruises.

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

Dosage and Administration

Adults aged 18 years and older are advised to apply only one patch at a time. Prior to application, the affected area should be cleaned and dried thoroughly. The patch should be removed from its backing film and applied directly to the skin, ensuring proper adherence. Each patch may be left in place for a duration of 8 to 12 hours.

If pain persists after the initial patch application, a second patch may be applied for an additional 8 to 12 hours. It is important to note that no more than two patches should be used in a single day, and the product should not be used for more than three consecutive days. When applying a new patch, the used patch must be removed from the skin.

This product is not recommended for use in children under 18 years of age, as its efficacy has not been established in this population.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the face or any rashes, as this may lead to adverse reactions. It is also contraindicated for use on wounds or damaged skin due to the risk of irritation and infection. Patients with a known allergy to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) should avoid this product to prevent allergic reactions.

Application of the product in conjunction with a heating pad is contraindicated, as this may increase the risk of skin burns or other complications. Additionally, the product should not be used when the patient is sweating, such as during exercise or exposure to heat, as this may affect the product's efficacy and safety.

Any patch from a pouch that has been open for 14 days or more should not be used, as the integrity and effectiveness of the product may be compromised. Finally, the product is contraindicated for use immediately before or after heart surgery due to potential complications.

Warnings and Precautions

For external use only. This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. Although the overall risk is low, certain factors can elevate this risk, including age (60 years or older), a history of stomach ulcers or bleeding disorders, concurrent use of anticoagulants or steroid medications, use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), consumption of three or more alcoholic drinks daily while using this product, and exceeding the recommended dosage or duration of use.

General precautions must be observed to ensure safe application. The product should not be applied to the face, rashes, wounds, or damaged skin. Individuals with known allergies to aspirin or other NSAIDs should refrain from using this product. It is also contraindicated for use with heating pads and should not be applied during periods of sweating, such as after exercise or exposure to heat. Patches from opened pouches should not be used if they have been open for 14 days or longer. Additionally, this product should not be used immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a physician prior to use if they have allergies to topical products, if the stomach bleeding warning is applicable, if they are taking diuretics, or if they have a history of high blood pressure, heart disease, or kidney disease.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and contact a healthcare provider if they experience worsening stomach pain or upset, faintness, vomiting blood, or the presence of bloody or black stools, as these may indicate stomach bleeding. Additional reasons to stop use include the development of a rash, itching, or skin irritation, worsening of the condition, persistence of symptoms beyond three days, or recurrence of symptoms after initial resolution.

Side Effects

Patients using this product should be aware that it is for external use only. The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may pose a risk of stomach bleeding. Although the overall chance of experiencing this adverse reaction is small, it is significantly increased in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily while using the product, or exceed the recommended dosage or duration of use.

Patients should not use this product on the face, rashes, wounds, or damaged skin, and it is contraindicated in individuals with known allergies to aspirin or other NSAIDs. Additionally, the product should not be used in conjunction with a heating pad, during periods of sweating (such as from exercise or heat), or with any patch from a pouch that has been open for 14 days or more. It is also advised against use immediately before or after heart surgery.

Before using this product, patients should consult a healthcare professional if they have allergies to topical products, if the stomach bleeding warning applies to them, if they are taking diuretics, or if they have high blood pressure, heart disease, or kidney disease.

While using this product, patients should wash their hands after applying or removing the patch and avoid contact with the eyes. In the event of eye contact, it is important to rinse thoroughly with water. There is an increased risk of heart attack or stroke if the product is used in excess of the directed dosage or for longer than recommended.

Patients should discontinue use and seek medical advice if they experience worsening stomach pain or upset, faintness, vomiting blood, or notice bloody or black stools, as these may indicate stomach bleeding. Other reasons to stop use include the development of a rash, itching, or skin irritation, worsening of the condition, persistence of symptoms beyond three days, or recurrence of symptoms after they have cleared.

For pregnant or breastfeeding patients, it is crucial to consult a healthcare professional before use. The use of methyl salicylate is particularly discouraged after 20 weeks of pregnancy unless specifically directed by a doctor, as it may lead to complications for the unborn child or during delivery.

This product should be kept out of reach of children. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary. The packaging is not child-resistant, and used patches should be disposed of properly by folding the sticky ends together.

Drug Interactions

The presence of a nonsteroidal anti-inflammatory drug (NSAID) in this product may increase the risk of gastrointestinal bleeding, particularly in patients concurrently using certain medications.

Anticoagulants and Steroids The risk of stomach bleeding is elevated when this product is used in conjunction with blood thinners (anticoagulants) or steroid medications. It is advisable for patients to consult a healthcare professional prior to using this product if they are on such therapies.

Other NSAIDs Concurrent use of this product with other NSAIDs, including but not limited to aspirin, ibuprofen, and naproxen, may also heighten the risk of gastrointestinal complications. Patients should be advised to avoid the simultaneous use of multiple NSAIDs.

Diuretics Patients taking diuretics should seek medical advice before using this product, as there may be specific considerations or adjustments necessary for safe use. Monitoring may be warranted in these cases to ensure patient safety and efficacy of treatment.

Packaging & NDC

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

Pediatric Use

Children under 18 years of age should not use this product, as it has not been shown to be effective in this population. Additionally, it is important to keep the product out of reach of children due to safety concerns. The packaging is not child-resistant, which further emphasizes the need for careful storage to prevent accidental ingestion.

Geriatric Use

Elderly patients may be at an increased risk for stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). While the overall chance of experiencing such adverse effects is small, it is notably higher in patients aged 60 years and older.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients. Close monitoring for signs of gastrointestinal bleeding is recommended, particularly in this age group. Additionally, consideration should be given to the potential need for dosage adjustments or alternative therapies that may pose a lower risk of gastrointestinal complications in elderly patients.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, particularly if they are in the later stages of pregnancy or breastfeeding. Methyl salicylate is contraindicated for use at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the developing fetus and could lead to complications during delivery. It is essential for women of childbearing potential to weigh the potential benefits against the risks when considering the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of methyl salicylate at 20 weeks of gestation or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering its use during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of high blood pressure, heart disease, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

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 overdosage, immediate medical assistance is crucial. If the product is ingested, healthcare professionals should be contacted without delay, or the individual should reach out to a Poison Control Center for guidance.

It is important to note that the packaging of the product is not child-resistant, which may increase the risk of accidental ingestion, particularly in pediatric populations. Therefore, caregivers should exercise caution and ensure that the product is stored securely out of reach of children.

When disposing of used patches, it is recommended to fold the sticky ends together to prevent accidental exposure or ingestion. Proper disposal methods should be followed to minimize risks associated with overdosage.

Nonclinical Toxicology

It is especially important not to use methyl salicylate at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include rash, itching, and skin irritation. Additionally, reports of serious adverse reactions, such as gastrointestinal bleeding, have been received. There is an indication that the risk of heart attack or stroke may increase if the product is used in excess of the recommended dosage or for a duration longer than directed.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is ingested. It is important to inform patients that the packaging is not child-resistant and to instruct them on the proper disposal of used patches by folding the sticky ends together.

Patients should be reminded to wash their hands thoroughly after applying or removing the patch and to avoid contact with their eyes. In the event of eye contact, they should rinse their eyes thoroughly with water.

Providers should discuss the potential risks associated with the use of this product, particularly the increased risk of heart attack or stroke if patients use more than the recommended dosage or for an extended period. Patients should be instructed to discontinue use and consult a doctor if they experience worsening stomach pain or upset.

Additionally, patients should be made aware of serious side effects, such as feeling faint, vomiting blood, or noticing bloody or black stools, which may indicate stomach bleeding. They should also be advised to stop using the product and seek medical advice if they develop a rash, itching, or skin irritation, if their condition worsens, or if symptoms persist for more than three days. If symptoms resolve and then recur within a few days, patients should also consult a healthcare professional.

Finally, healthcare providers should emphasize the importance of consulting a health professional before use if the patient is pregnant or breastfeeding. It is particularly crucial to avoid the use of methyl salicylate after 20 weeks of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). Care should be taken to avoid storing the product in direct sunlight, and it must be protected from excessive moisture to maintain its integrity and efficacy.

Additional Clinical Information

The route of administration for the medication is topical, percutaneous, and transdermal. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of methyl salicylate after 20 weeks of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)