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Eagle Brand

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Active ingredients
  • Menthol 1.222 g/10 g
  • Methyl Salicylate 2.466 g/10 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 2025
Label revision date
August 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 1.222 g/10 g
  • Methyl Salicylate 2.466 g/10 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 2025
Label revision date
August 18, 2025
Manufacturer
PT. EAGLE INDO PHARMA
Registration number
M017
NDC root
60954-299
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 your muscles and joints. It can be helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains.

While the specific mechanism of action isn't detailed, its purpose is to alleviate discomfort associated with these common issues, allowing you to feel more comfortable in your daily activities.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains. This means if you're experiencing discomfort from these issues, this medication may help alleviate your pain and improve your comfort.

It's important to note that there are no reported 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

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 product safely and effectively. You should not apply it to wounds or damaged skin, and avoid bandaging tightly over the area where it's applied. If you notice excessive irritation of the skin, discontinue use immediately. Always follow the directions provided and do not use the product in any way other than as instructed.

By adhering to these guidelines, you can help ensure a safe experience with the product.

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 you notice excessive irritation, stop using the product. If your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days, please consult your doctor.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

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 not bandage the area tightly. If you notice excessive irritation on your skin, stop using the product immediately.

If your condition worsens, or if your symptoms last more than 7 days or return shortly after improvement, discontinue use and consult your doctor. In case of accidental swallowing, seek medical help or contact a Poison Control Centre right away. Always use this product as directed to ensure your safety.

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 symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, it’s always better to be safe and consult a professional 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 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 and any medications you may consider.

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. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

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).

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 interactions with other drugs or laboratory tests. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account your unique health needs. Always feel free to ask questions and share any concerns you may have regarding your medications or tests.

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, be sure to follow any specific instructions provided to avoid contamination or damage. Always ensure that your hands and any surfaces are clean to maintain a safe environment. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor aches and pains of muscles and joints 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 this drug. Children under 2 years of age should not use it without consulting 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, this product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply 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, you should discontinue use and consult a doctor.

What should I do if I accidentally swallow this drug?

If swallowed, seek medical help or contact a Poison Control Centre immediately.

Are there any contraindications for this drug?

No specific contraindications are mentioned, but do not use if excessive irritation of the skin develops.

What is the storage requirement for this drug?

You should store this drug 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

The product is available in two packaging sizes: 10 grams (NDC: 60954-299-10) and 20 grams (NDC: 60954-299-20).

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 frequency is to apply the product to the affected area no 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 product to this age group to ensure safety and appropriateness of treatment.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse reactions. 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 response. Use is strictly limited to the directions provided; deviations from these instructions are contraindicated to ensure safety and efficacy.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes to prevent irritation. It is imperative that the product not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications.

Patients should be instructed not to bandage the area tightly after application, as this could increase the risk of adverse effects. In cases where excessive skin irritation develops, the use of the product should be discontinued immediately. It is essential that patients adhere strictly to the directions provided; any use outside of these guidelines is not recommended.

Should the condition worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients must discontinue use and seek medical advice. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is advised.

Side Effects

Patients using this product may experience adverse reactions primarily related to improper use or application. It is important to note that this product is for external use only. Users should avoid contact with the eyes and mucous membranes, and it should not be applied to wounds or damaged skin. Additionally, tight bandaging is not recommended.

In the event of excessive skin irritation, patients are advised to discontinue use and consult a healthcare professional. If the condition worsens, or if symptoms persist for more than 7 days or recur shortly after resolution, it is essential to stop using the product and seek medical advice.

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 Centre is recommended.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. 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 not 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure appropriate management 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 drug 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 Centre without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

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

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 indicated that the product is utilized for the temporary relief of minor aches and pains associated with various conditions, including simple backache, arthritis, strains, bruises, and sprains. Reports of adverse events have been collected voluntarily and through surveillance programs.

For inquiries or to report serious side effects, healthcare professionals and patients are encouraged to contact the designated helplines at 1-800-777-6717 or 1-800-645-0769.

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 if symptoms clear up 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 bandaging the area tightly. Additionally, healthcare providers should instruct patients 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 must be adhered to, and the product should be kept in its original container to protect it from environmental factors. Special handling requirements should be observed to maintain 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.