E Mei Shan Medicated

Description

E Mei Shan Medicated Plaster is an external analgesic indicated for the relief of localized pain. Each plaster measures 7 x 10 cm (2.76 x 3.94 inches) and is designed for topical application. The product is identified by the National Drug Code (NDC) 54494-001-01.

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 3 years and older, the protective film from the plaster should be removed prior to application. The plaster is to be applied to the affected area no more than 3 to 4 times daily.

For children under 3 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application on irritated or damaged skin is prohibited due to the potential for exacerbating the condition. The product should not be applied to open wounds, as this may lead to infection or delayed healing. Additionally, use must adhere strictly to the provided directions; deviations from these instructions are contraindicated.

Contact with the eyes or mucous membranes should be avoided to prevent irritation. Tight bandaging is not recommended, as it may compromise circulation. Furthermore, application on extremely hairy areas of skin is discouraged to minimize irritation during removal of the plaster.

Warnings and Precautions

For external use only. This product contains natural rubber latex, which may cause allergic reactions in sensitive individuals. Healthcare professionals should be aware of this allergy alert when recommending this product to patients.

It is imperative to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens; symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; excessive skin irritation develops; or gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest. Specifically, for patients using this product for arthritis-related pain, they should seek medical advice if pain persists for more than 10 days, if redness is observed, or if the product is being used in children under 12 years of age.

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a warning regarding the presence of natural rubber latex, which may lead to allergic reactions in susceptible individuals.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: if the condition worsens; if symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; if excessive skin irritation develops; or if gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest.

For patients using the product for arthritis-related pain, it is particularly important to seek medical advice if pain persists for more than 10 days, if redness is observed, or if the product is being used in children under 12 years of age.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 3 years of age should consult a physician prior to use. For children aged 3 years and older, the protective film from the plaster should be removed before application to the affected area, which may be done no more than 3 to 4 times daily.

In children under 12 years of age, it is advised to discontinue use and seek medical advice if pain persists for more than 10 days or if redness is present.

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 should be advised against using this product on irritated or damaged skin, as well as on wounds, due to the potential for adverse effects. It is important for healthcare professionals to counsel women of childbearing potential to consult their physician if they have children under 3 years of age, as specific recommendations may be necessary for this population.

In the event that pregnant patients experience nausea, vomiting, abdominal discomfort, diarrhea, or skin rash while using this product, they should discontinue use and seek medical advice promptly. Additionally, to prevent accidental poisoning, this product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to 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

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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 use of the compound in these contexts.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number provided for this purpose.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on irritated or damaged skin, or on wounds. It is essential to emphasize that the product should only be used as directed. If the patient's condition worsens, they should stop using the product and consult a doctor. Additionally, patients should be advised to seek medical advice if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if excessive skin irritation develops.

Patients should also be made aware that they need to consult a doctor if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash while using the product. For those using the product for arthritis pain, they should stop use and contact a doctor if pain persists for more than 10 days or if redness is present.

It is important to inform patients that special caution should be taken when using this product in children under 12 years of age. Patients should avoid contact with the eyes or mucous membranes while using the product. They should also be advised not to bandage the area tightly and to avoid placing the product on extremely hairy areas of skin to minimize irritation during removal.

Storage and Handling

Plasters are supplied in a zip-lock pouch, which should be kept tightly closed to maintain product integrity. It is essential to store the plasters at a temperature range of 15º to 30º C (59º to 86º F). The storage location should be dry and away from direct sunlight to ensure optimal preservation of the product.

Additional Clinical Information

The transdermal route of administration is indicated for patients aged 3 years and older, who should apply the plaster to the affected area after removing the protective film, not exceeding 3 to 4 applications daily. For children under 3 years of age, consultation with a physician is recommended prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)