Emu Therapy Cool Menthol Therapy Pain Relief Cream

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. It is essential to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Healthcare professionals are advised to consult a physician prior to administering this medication to children under 2 years of age, as specific guidance is necessary for this age group.

Contraindications

The product is contraindicated for use on wounded, damaged, or irritated skin due to the potential for exacerbating the condition. Additionally, contact with eyes or mucous membranes should be avoided. Tight bandaging is also contraindicated, as it may lead to adverse effects. If a rash or reaction occurs, or if the condition worsens or symptoms persist beyond 10 days, or recur shortly after resolution, discontinue use and consult a healthcare professional.

Warnings and Precautions

This product is intended for external use only. It is imperative that it not be applied to wounded, damaged, or irritated skin to prevent exacerbation of the condition.

During application, care must be taken to avoid contact with the eyes and mucous membranes. Additionally, it is advised not to bandage the area tightly, as this may lead to increased irritation or adverse effects.

Users should discontinue use and consult a healthcare professional if a rash or any adverse reaction occurs, if the condition worsens, or if symptoms persist beyond 10 days. Should symptoms resolve and then reappear within a few days, medical advice should also be sought.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on wounded, damaged, or irritated skin. During use, patients are advised to avoid contact with the eyes and mucous membranes, and to refrain from tightly bandaging the area of application.

In the event of a rash or any adverse reaction, or if the condition worsens, patients should discontinue use and consult a healthcare professional. Additionally, if symptoms persist for more than 10 days or if they resolve and then recur within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional prior to use. Furthermore, this product should be kept 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.

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, routine monitoring or dosage adjustments related to drug or laboratory test interactions are not required.

Packaging & NDC

Below are the non-prescription pack sizes of Emu Therapy Cool Menthol Therapy Pain Relief Cream (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times a day. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 potential 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. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks specific details, and there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to wounded, damaged, or irritated skin to prevent further complications.

Patients should be informed to discontinue use and consult a doctor if they experience a rash or any adverse reaction, if their condition worsens, or if symptoms persist for more than 10 days, or if symptoms clear up and then recur within a few days.

Additionally, while using the product, patients should be cautioned to avoid contact with the eyes and mucous membranes. They should also be advised against tightly bandaging the area where the product is applied to ensure safety and effectiveness.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. Clinicians are advised to consult a doctor before administering the treatment to children under 2 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)