Salonpas Pain Relief

Description

Hisamitsu Salonpas is a topical analgesic patch designed for the temporary relief of mild to moderate pain associated with sore muscles, sprains, backache, and joint pain. Each patch contains 3% menthol and 10% methyl salicylate, providing effective pain relief as confirmed in clinical trials. The patches measure 2 3/4" x 3 15/16" (7 cm x 10 cm) and are packaged in quantities of five. The product is FDA approved for non-prescription use. It is recommended to apply the patch for a duration of 8 to 12 hours. The packaging is not child-resistant, and it is advised to keep the product out of reach of children. Users should not apply more than one Salonpas patch at a time; directions should be followed carefully. The National Drug Code (NDC) for this product is 46581-670-05.

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 must be cleaned and dried thoroughly. The patch should be removed from the 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.

In cases where pain persists after the initial patch application, a second patch may be applied for an additional 8 to 12 hours. It is imperative that no more than two patches are used in a single day, and the product should not be utilized for more than three consecutive days. When a new patch is applied, 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 on 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 nonsteroidal 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 may 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 when using this product. It should not be applied to the face, rashes, wounds, or damaged skin. Individuals with known allergies to aspirin or other NSAIDs should avoid use. The product should not be used in conjunction with heating pads or during periods of sweating, such as from exercise or heat. Additionally, any patch from a pouch that has been open for 14 days or more should not be used, nor should it be applied immediately before or after heart surgery.

Healthcare professionals should advise patients to consult a doctor 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 high blood pressure, heart disease, or kidney disease. While using this product, it is essential to wash hands after application or removal of the patch and to avoid contact with the eyes. In the event of eye contact, the affected area should be rinsed thoroughly with water. It is important to note that the risk of heart attack or stroke may increase with the use of higher than directed doses or prolonged use.

Patients should seek emergency medical assistance if the product is ingested. They should also 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. 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 resolved.

Side Effects

This product is intended for external use only. It 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, certain factors may increase the risk, including being age 60 or older, having a history of stomach ulcers or bleeding problems, concurrent use of blood thinners (anticoagulants) or steroid medications, taking other NSAIDs (such as aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily while using this product, or exceeding the recommended dosage or duration of use.

Patients should not use this product on the face, rashes, wounds, or damaged skin. It is contraindicated in individuals with known allergies to aspirin or other NSAIDs, those using a heating pad, individuals who are sweating (such as from exercise or heat), or those using any patch from a pouch that has been open for 14 or more days. Additionally, it should not be used right 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 a diuretic, or if they have high blood pressure, heart disease, or kidney disease.

While using this product, it is important for patients to wash their hands after applying or removing the patch and to avoid contact with the eyes. In the event of eye contact, the affected area should be rinsed thoroughly with water. Patients should be aware that the risk of heart attack or stroke may increase if the product is used in excess of the directed dosage or for longer than recommended.

Patients are advised to discontinue use and seek medical attention if they experience worsening stomach pain or upset, faintness, vomiting blood, or bloody or black stools, as these may be signs of 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 individuals, 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 pose risks to the unborn child or lead to complications 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 product contains a nonsteroidal anti-inflammatory drug (NSAID), which has the potential to increase the risk of gastrointestinal bleeding. This risk is elevated in patients concurrently using anticoagulants or steroid medications.

Co-administration with other NSAIDs, including but not limited to aspirin, ibuprofen, and naproxen, is contraindicated due to the potential for additive effects and increased risk of adverse reactions.

Patients taking diuretics should consult a healthcare professional prior to using this product, as there may be considerations for dosage adjustments or monitoring based on individual health status and concurrent medication use.

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

Pediatric patients under 18 years of age should not use this product, as its efficacy has not been established 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). Although 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 dose 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 healthcare professional before using this medication while breastfeeding. It is particularly important to avoid the use of methyl salicylate at 20 weeks of pregnancy 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 in lactating individuals.

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 degree of renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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 associated with the use of this product. Reports of rash, itching, and skin irritation have been documented. Additionally, there have been reports of stomach bleeding, particularly in patients who are older, have a history of stomach ulcers or bleeding problems, or are concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Furthermore, cases of heart attack or stroke have been reported in patients using this product, especially when utilized at higher doses or for durations exceeding the recommended guidelines.

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 they should be instructed to dispose of used patches by folding the sticky ends together to prevent accidental exposure.

Providers should also emphasize the necessity of consulting a healthcare professional before using the product if the patient is pregnant or breastfeeding. It is particularly crucial to highlight that methyl salicylate should not be used after 20 weeks of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Storage and Handling

The product is supplied in various packaging 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 exposure to direct sunlight, and the product 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)