Salonpas

Description

Salonpas Pain Relieving Patch is an over-the-counter topical analgesic product manufactured by Hisamitsu, recognized as the world's number one brand in its category. Each patch measures 5.67 inches by 3.62 inches (14.4 cm by 9.2 cm) and is designed for the temporary relief of minor aches and pains, including backache, sore shoulder, stiff neck, and joint pain. The patches are intended for application for a duration of 8 hours and are packaged in a box containing 6 patches. The product is identified by NDC# 46581-210-06 and is made in Japan.

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

For adults and children aged 12 years and over, the affected area should be cleaned and dried prior to application. The patch must 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 healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, concurrent use with a heating pad is contraindicated as it may increase the risk of burns or other injuries. Furthermore, individuals with known allergies to any of the product's ingredients should avoid its use to prevent allergic reactions.

Warnings and Precautions

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

This product is contraindicated for application on wounds or damaged skin. Additionally, it should not be used in conjunction with a heating pad, as this may exacerbate adverse effects.

Patients must be cautioned against using this product if they are allergic to any of its ingredients. When administering this product, it is imperative to follow the directions precisely. Users should avoid contact with the eyes, mucous membranes, or any rashes, and should refrain from applying tight bandages over the treated area.

In the event of rash, itching, or excessive skin irritation, patients should discontinue use and seek medical advice. Furthermore, if the condition worsens, symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, medical consultation is necessary.

This product should be stored out of reach of children. In cases 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 important to avoid contact with the eyes, mucous membranes, or rashes, and to refrain from tightly bandaging the area of application.

While using this product, patients must adhere strictly to the directions provided. They should discontinue use and seek medical advice if they experience rash, itching, or excessive skin irritation. Furthermore, if the condition worsens, symptoms persist beyond seven days, or if symptoms resolve and then recur within a few days, medical consultation is recommended.

Additional considerations include the need for pregnant or breastfeeding individuals to consult a healthcare professional before use. It is also crucial to keep this product out of reach of children; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to using this medication, 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 healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 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 individuals 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 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 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.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: rash, itching, and excessive skin irritation. These events have been documented in the context of ongoing safety monitoring.

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 use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed that they must not use the product if they are allergic to any of its ingredients. They should be counseled to discontinue use and consult a doctor if they experience rash, itching, or excessive skin irritation. 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 should be reminded to follow the directions carefully and to avoid contact with the eyes, mucous membranes, or rashes. They should also be cautioned against tightly bandaging the area where the product is applied. Furthermore, patients with a history of allergic reactions to aspirin or salicylates should be encouraged to consult a doctor prior to use.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from direct sunlight to maintain its integrity. Additionally, the product must be protected from excessive moisture to ensure optimal quality and efficacy. Proper handling and storage conditions are crucial for preserving the product's effectiveness.

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)