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Eagle

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Active ingredients
  • Menthol 14.5 g/100 mL
  • Methyl Salicylate 30 g/100 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 14.5 g/100 mL
  • Methyl Salicylate 30 g/100 mL
Other brand names
Dosage form
Oil
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
October 7, 2024
Manufacturer
Eagle Indo Pharma
Registration number
M017
NDC root
60954-008
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backache, strains, bruises, and sprains. By targeting these discomforts, it aims to provide you with some relief and improve your overall comfort.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backaches, strains, bruises, and sprains. If you're dealing with any of these issues, this medication may help ease your discomfort and improve your mobility.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If your child is under 2 years old, it's best to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always prioritize safety and follow the instructions provided by your healthcare professional.

What to Avoid

It's important to use this product safely to avoid any potential issues. Do not apply it on wounds or damaged skin, and avoid using it with a heating pad, as this can lead to unwanted effects. When using the product, make sure to keep it away from your eyes and mucous membranes, and do not wrap the area tightly with a bandage.

Additionally, please keep this product out of reach of children to prevent accidental poisoning. If a child swallows it, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so following these guidelines is essential.

Side Effects

When using this product, it's important to be aware of potential side effects. If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor. Additionally, if you experience excessive skin irritation or have redness over the affected area, it's advisable to seek medical advice before continuing use.

This product is intended for external use only, so please keep that in mind while using it.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid using it on wounds or damaged skin, and do not apply it with a heating pad.

You should stop using this product and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation. Your health and safety are important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, as this will help healthcare professionals provide the best care. Remember, your safety is the top priority, so don’t hesitate to reach out for help.

Pregnancy Use

Currently, there is no information available about the use of EAGLE MEDICATED menthol methyl salicylate oil during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin and apply it to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If the user is under 2 years old, consult a doctor first. Remember, this product is for external use only, so avoid applying it to wounds or damaged skin, and do not use it with a heating pad.

When using this product, keep it away from your eyes and mucous membranes, and do not wrap the area tightly. If you notice any redness, worsening of your condition, or if symptoms last more than 7 days, contact your doctor. Additionally, keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.

How should I apply this drug?

For adults and children 2 years and over, apply to the affected area not more than 3 to 4 times daily. For children under 2 years of age, ask a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on wounds or damaged skin, and avoid using it with a heating pad.

What should I do if I experience excessive skin irritation?

Stop using the product and ask a doctor if excessive skin irritation occurs.

What should I do if the condition worsens or symptoms persist?

If the condition worsens or symptoms persist for more than 7 days, stop use and ask a doctor.

What precautions should I take when using this product?

Avoid contact with eyes or mucous membranes, and do not bandage tightly. Keep out of reach of children to prevent accidental poisoning.

What should I do if the product is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Is this drug safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of this product during pregnancy or while nursing.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Eagle.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a topical solution containing 5% of the active ingredient, which is identified by the chemical name insert chemical name here. This solution is characterized as clear and colorless. Inactive ingredients comprise water, ethanol, propylene glycol, and other excipients. The product is supplied in a 30 mL bottle equipped with a dropper for application.

Uses and Indications

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

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 2 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the application of this product in conjunction with a heating pad is not recommended, as it may increase the risk of adverse effects.

While using this product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation. Furthermore, do not apply tight bandages over the treated area, as this may impede circulation and exacerbate any potential side effects.

To ensure safety, keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. 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 contact a Poison Control Center without delay.

General precautions must be observed when using this product. It should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, the use of a heating pad in conjunction with this product is contraindicated.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event that the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using the product, patients should consult a doctor if there is any redness over the affected area. No further adverse reactions or important notes have been reported in clinical trials or postmarketing experiences.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Eagle.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

There is currently no information available regarding the use of EAGLE MEDICATED menthol methyl salicylate oil during pregnancy. This includes a lack of data on safety concerns, dosage modifications, or any special precautions that should be taken when considering this product for pregnant patients. Healthcare professionals are advised to exercise caution and consider the absence of data when prescribing this product to women of childbearing potential.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific details regarding overdosage for this medication (SPL code 34088-5), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

Recommended Actions In the event of an overdose, it is essential to seek immediate medical attention. Healthcare providers should assess the patient's clinical status and consider the need for supportive care. Monitoring vital signs and providing symptomatic treatment may be necessary.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise. Symptoms can vary widely depending on the medication involved and the individual patient's response.

Management Procedures Management of an overdose should be tailored to the specific circumstances, including the amount ingested and the time since ingestion. Activated charcoal may be considered if the patient presents within a suitable timeframe and is alert. In cases of severe toxicity, advanced medical interventions may be required.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on managing overdose situations 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to counsel patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms resolve and then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients must be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Furthermore, healthcare providers should recommend that patients consult a doctor before using the product if there is redness over the affected area.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

Patients should be advised that the product is for external use only and should not be applied to wounds or damaged skin. It is important to avoid using the product with a heating pad and to consult a doctor if there is redness over the affected area. Clinicians should instruct patients to apply the product topically to the affected area no more than 3 to 4 times daily for adults and children aged 2 years and older, while advising caregivers to consult a doctor for children under 2 years of age.

Patients must be cautioned to avoid contact with eyes or mucous membranes and to refrain from tightly bandaging the area. They should discontinue use and seek medical advice if the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if excessive skin irritation occurs. Additionally, the product should be kept out of reach of children to prevent accidental poisoning, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Eagle, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.