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Eagle Brand

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Active ingredients
  • Menthol 13.5 g/100 g
  • Methyl Salicylate 29.95 g/100 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
March 11, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 13.5 g/100 g
  • Methyl Salicylate 29.95 g/100 g
Other brand names
Dosage form
Ointment
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 2015
Label revision date
March 11, 2026
Manufacturer
PT. EAGLE INDO PHARMA
Registration number
M017
NDC root
60954-200
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 your muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains. By targeting these discomforts, it aims to help you feel more comfortable and active in your daily life.

Uses

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

You can rely on it to ease discomfort from these common issues, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage these minor ailments.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this 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 avoid any potential issues. You should not apply it to wounds or damaged skin, and avoid bandaging tightly over the area. If you notice excessive irritation of the skin, discontinue use immediately. Always follow the directions provided and do not use the medication in any way other than as instructed. This will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of potential side effects. You should avoid contact with your eyes and mucous membranes, and do not apply it to wounds or damaged skin. If you experience excessive skin irritation, stop using the product immediately. If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes or any mucous membranes. Do not apply it to wounds or damaged skin, and avoid wrapping the area tightly. If you notice excessive irritation on your skin, stop using the product immediately. Always follow the directions provided.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, discontinue use and consult your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Centre right away.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product to ensure it's safe for you.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Centre immediately. Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior.

Don't wait to see if symptoms develop; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the steps to take in case of an overdose. Your safety and well-being are the top priority.

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 you understand any potential risks. Always prioritize your health and the health of your baby by seeking expert advice.

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

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 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

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 and in a clean environment to avoid 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 the purpose of this drug?

This drug is used for the temporary relief of minor aches and pains of muscles and joints.

What conditions can this drug help relieve?

It can help relieve minor aches and pains associated with simple backache, arthritis, strains, bruises, and sprains.

Who can use this drug?

Adults and children 2 years of age and older can use it, but children under 2 years should consult a doctor.

How should I apply this drug?

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, avoid getting it in your eyes or mucous membranes, do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do if my condition worsens?

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

Is it safe to use if I am pregnant or breastfeeding?

You should ask a health professional before use if you are pregnant or breastfeeding.

What should I do if the drug is swallowed?

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

How should I store this drug?

Store it below 86°F (30°C).

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

No description information is available for the drug.

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 ensure safety and appropriateness for 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. Tight bandaging is also contraindicated, as it may exacerbate skin irritation or compromise circulation. Additionally, the product should not be used if excessive skin irritation develops, as this may indicate an adverse reaction. Use of the product must strictly adhere to the provided directions to ensure safety and efficacy.

Warnings and Precautions

For external use only, this product should not come into contact with the eyes or mucous membranes. It is imperative to avoid application on wounds or damaged skin, and users should refrain from tightly bandaging the area of application. In the event of excessive skin irritation, the use of this product should be discontinued immediately. It is essential to use this product strictly as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to stop using the product and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

General precautions include consulting a healthcare professional prior to use in pregnant or breastfeeding individuals to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, patients should refrain from tightly bandaging the area where the product is applied. If excessive irritation of the skin develops, the use of this product should be discontinued.

In clinical practice, patients are advised to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. Furthermore, this product should 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 Centre should be made.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, 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 and must consult a healthcare professional for guidance. 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 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients 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. 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 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 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 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 strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage 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 various surveillance programs. The nature of these reports underscores the importance of ongoing monitoring and communication regarding the safety profile of the product.

Patient Counseling

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

Patients should be cautioned to avoid contact with the eyes and mucous membranes. They must not apply the product to wounds or damaged skin, and should refrain from tightly bandaging the area where the product is applied. Additionally, patients should be instructed not to use the product if excessive irritation of the skin develops. It is essential to emphasize that the product should only be used 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.

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.