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Eagle Brand

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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 2024
Label revision date
June 25, 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 2024
Label revision date
June 25, 2024
Manufacturer
PT. EAGLE INDO PHARMA
Registration number
M017
NDC root
60954-015
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 provide temporary relief from minor aches and pains in muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. If you're experiencing discomfort from any of these issues, this product may be a suitable option to consider for alleviating your pain.

Uses

If you're experiencing minor aches and pains in your muscles and joints, this medication can provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on this treatment to help ease discomfort associated with these common issues, allowing you to feel more comfortable in your daily activities.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should never apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging tightly over the area where the medication is applied, as this can affect its effectiveness and safety. Always follow the directions provided and do not use the medication in any way other than as instructed. This will help you achieve the best results while minimizing any potential risks.

Side Effects

When using this product, it's important to apply it only to the skin and avoid contact with your eyes or mucous membranes. Do not use it on wounds or damaged skin, and avoid tight bandaging. If your condition worsens, symptoms last more than 7 days, or if they clear up and return shortly after, stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, seek medical advice.

In case of accidental ingestion, seek medical help immediately or contact a Poison Control Centre. Always use the product as directed to minimize risks.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. It's important not to use it on wounds or damaged skin, and you should avoid tightly bandaging the area where you apply it. Always follow the directions provided.

If your condition worsens, or if your symptoms last more than 7 days or return shortly after improving, stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, discontinue use and seek medical advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Centre immediately. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Centre or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider regarding any medications you may be considering during pregnancy.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 performance and safety of your product, store it in a cool place, keeping the temperature below 86°F (30°C). This helps maintain its effectiveness and integrity.

When handling the product, always do so with clean hands or gloves to prevent contamination. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and careful handling are key to ensuring your product works as intended.

Additional Information

No further information is available.

FAQ

What is this product used for?

This product is used for temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 2 years of age should not use it and should consult a doctor.

How should I apply this product?

You should apply it to the affected area not more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid getting it into your eyes or on mucous membranes, and do not apply it to wounds or damaged skin.

What should I do if my condition worsens?

If your condition worsens or if symptoms persist for more than 7 days, discontinue use and consult a doctor.

What should I do if I accidentally swallow this product?

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

Is there any specific storage requirement for this product?

Yes, store this product below 86°F (30°C).

Can I use this product if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

Packaging Info

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

Packaging configurations for Eagle Brand.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is available in two formulations: a 24 ml container with National Drug Code (NDC) 60954-015-24 and a 36 ml container with NDC 60954-015-36. Each formulation is designed for specific dosing requirements, ensuring appropriate administration in clinical settings.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, tight bandaging is not recommended, as it may lead to complications. The product should only be used as directed; any deviation from the specified instructions is contraindicated to ensure safety and efficacy.

Warnings and Precautions

For external use only. It is imperative that this product is not applied to the eyes or mucous membranes, as contact may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds or damaged skin, and care should be taken to avoid tight bandaging after application. The product must be used strictly as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be instructed to stop use if excessive skin irritation develops.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Centre should be contacted without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes and mucous membranes, as well as to refrain from applying it to wounds or damaged skin. It is also advised not to bandage the area tightly and to use the product strictly as directed.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a healthcare professional. Additionally, if excessive skin irritation develops, it is recommended to stop use and seek medical advice.

In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

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 Brand (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Eagle Brand.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. 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

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 should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 prudent 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, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Centre without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any overdosage incidents to facilitate effective treatment and minimize risks.

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

Postmarketing experience has included reports of serious side effects, which can be communicated through the designated contact numbers: 1-800-777-6717 or 1-800-645-0769. These reports have been collected voluntarily and through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. Patients should be informed that if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should discontinue use of the product and consult a doctor.

It is important to instruct patients to discontinue use if excessive skin irritation develops. Providers should emphasize the necessity of avoiding contact with the eyes and mucous membranes, and patients should be cautioned against applying the product to wounds or damaged skin. Additionally, patients should be advised not to bandage the area tightly and to use the product only as directed.

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 controlled environment, maintaining a temperature below 86°F (30°C) to ensure its stability and efficacy. Proper storage conditions are critical to preserving the integrity of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Eagle Brand, 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 Brand, 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.