Salonpas

Description

Salonpas Pain Relieving Patch is an over-the-counter topical analgesic in the patch category, recognized as the world's brand number one. Each patch measures 2.83 inches by 1.81 inches (7.2 cm by 4.6 cm) and is designed for the temporary relief of minor aches and pains, including stiff neck, sore shoulder, backache, and joint pain. The product is manufactured in Japan and is available in a package containing 60 patches. The recommended application duration is up to 8 hours. Hisamitsu NDC#46581-110-60.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and over should begin by cleaning and drying the affected area. The patch should then be removed from its protective film and applied directly to the affected area. It is recommended that the patch be applied no more than 3 to 4 times daily. Each patch should be removed from the skin after a maximum application duration of 8 hours.

For children under 12 years of age, it is advised to consult a doctor prior to use to determine appropriate treatment options and dosages.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. It should not be used in conjunction with a heating pad, as this may increase the risk of burns or adverse reactions. Additionally, individuals with known allergies to any ingredients in this product should refrain from use to prevent allergic reactions.

While using this product, it is essential to avoid contact with the eyes, mucous membranes, or rashes to prevent irritation. Furthermore, tight bandaging is not recommended, as it may impede circulation and lead to complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of allergic reactions to aspirin or salicylates.

This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Patients with known allergies to any ingredients in this formulation are advised against its use.

When utilizing this product, it is imperative to follow the directions provided. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes. Additionally, patients should refrain from applying tight bandages over the treated area.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: rash, itching, or excessive skin irritation; worsening of the condition; persistence of symptoms beyond 7 days; or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is contraindicated for those who are allergic to any of the product's ingredients.

When using this product, it is essential to follow the directions provided. Patients should avoid contact with the eyes, mucous membranes, or any rashes, and should not apply a tight bandage over the area of application.

Patients are instructed to discontinue use and seek medical advice if they experience a rash, itching, or excessive skin irritation. They should also consult a 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.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before using this product. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor prior to use. For adolescents aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The patch should be removed from the skin after a maximum application duration of 8 hours.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 regarding the excretion of this drug 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 not been specifically addressed in the drug insert 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 absence of detailed guidance 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 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. 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 an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control experts is recommended to guide the management and ensure the best possible care for the patient.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: rash, itching, and excessive skin irritation. These events were documented in the context of routine pharmacovigilance activities.

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 to instruct patients not to apply the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed of the potential for allergic reactions; they should not use the product if they are allergic to any of its ingredients. Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if any rash, itching, or excessive skin irritation develops. 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 resolve and then recur within a few days.

When using the product, patients must be instructed to follow the directions carefully. They should avoid contact with the eyes, mucous membranes, or rashes, and should not apply a tight bandage over the area of application. It is also crucial to alert patients who are prone to allergic reactions from aspirin or salicylates to consult a doctor 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 in a cool, dry place, avoiding direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and effectiveness. Proper handling and storage conditions are crucial for preserving the product's stability and efficacy.

Additional Clinical Information

The route of administration for the medication is topical, percutaneous, and transdermal. Patients are advised to apply the treatment to the affected area no more than 3 to 4 times daily and to remove the patch from the skin after a maximum of 8 hours of application.

Clinicians should counsel patients to consult a doctor prior to use if they have a history of allergic reactions to aspirin or salicylates. Additionally, pregnant or breastfeeding patients should seek advice from a health professional before using the product. It is important to keep the medication out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)