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Eagle Brand

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Active ingredients
  • Camphor (synthetic) 7 g/100 mL
  • Menthol 16 g/100 mL
  • Methyl Salicylate 35 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 2023
Label revision date
January 20, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 7 g/100 mL
  • Menthol 16 g/100 mL
  • Methyl Salicylate 35 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 2023
Label revision date
January 20, 2025
Manufacturer
PT. EAGLE INDO PHARMA
Registration number
M017
NDC root
60954-017
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 provides temporary relief from minor aches and pains in your muscles and joints. It is commonly used for conditions such as simple backache, arthritis, strains, bruises, and sprains. By targeting these discomforts, it helps you feel more comfortable and active in your daily life.

Uses

If you're experiencing 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 this treatment to ease discomfort and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of pain.

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 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 may cause irritation or other issues. Always follow the directions provided and do not use the medication in any way that is not specified. By adhering to these guidelines, you can help ensure that you use the medication effectively and safely.

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.

If the product is swallowed, 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 be sure to avoid contact with your eyes and mucous membranes. Do not apply it to any wounds or damaged skin, and avoid wrapping the area tightly after application. Always use the product as directed.

If your condition worsens, or if symptoms last longer than 7 days or return after improvement, 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 ingestion, it’s important to get emergency medical help or contact a Poison Control Centre immediately.

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 get checked by a medical professional.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or medications, as they can provide personalized advice tailored to your needs. Your safety and well-being are the top priority!

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 care to avoid any damage. Make sure to follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is the general use of this drug?

This drug provides temporary relief of minor aches and pains of muscles and joints.

What conditions is this drug associated with?

It is associated with simple backache, arthritis, strains, bruises, and sprains.

Who can use this drug?

Adults and children 2 years of age and older can apply it to the affected area 3 to 4 times daily. Children under 2 years should not use it without consulting a doctor.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I avoid while using this product?

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

Is this drug safe to use during pregnancy or breastfeeding?

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

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 (camphor, 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 supplied in an 8 mL unit box, with the National Drug Code (NDC) 60954-017-08.

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. Additionally, tight bandaging is not recommended, as it may compromise circulation and lead to further complications. The product should only be used as directed to ensure safety and efficacy.

Warnings and Precautions

The product is intended for external use only. It is imperative to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be bandaged tightly, and it must be used strictly as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to discontinue use and seek medical advice 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 excessive skin irritation, immediate consultation with a healthcare provider is recommended.

In the event of accidental ingestion, it is crucial to obtain emergency medical assistance or contact a Poison Control Centre 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 (camphor, 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

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 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 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 mothers.

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 drug. 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 surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. Healthcare providers should emphasize the importance of discontinuing use and consulting a doctor if the patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up only to recur within a few days.

Patients should be informed to monitor for excessive skin irritation and to discontinue use if such irritation develops. It is crucial to instruct patients to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. Additionally, patients should be cautioned against tightly bandaging the area where the product is applied. Finally, healthcare providers should stress the importance of using the product only as directed and not for any other purposes.

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.