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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
May 13, 2024
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
May 13, 2024
Manufacturer
PT. EAGLE INDO PHARMA
Registration number
M017
NDC root
60954-014
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 is commonly used for conditions such as simple backache, arthritis, strains, bruises, and sprains. By targeting these specific areas of discomfort, it helps you manage pain and improve your mobility.

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, while it can help with these specific types of pain, it's always a good idea to consult with a healthcare professional if you have any concerns or if your symptoms persist.

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 the patient 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 young children.

What to Avoid

It's important to use this medication safely and effectively. You should not apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly, as this may interfere with the medication's action. 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 best possible outcome from your treatment.

Side Effects

This product is for external use only, so be sure to avoid contact with your eyes and mucous membranes. It's important not to apply it to wounds or damaged skin, and you should avoid tightly bandaging the area. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and 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 Centre immediately.

Warnings and Precautions

This product is for external use only, so please avoid getting it in your eyes or on sensitive areas like mucous membranes. It's important not to apply it to any wounds or damaged skin, and you should avoid tightly bandaging the area where you apply it. Always use the product exactly as directed.

If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and consult your doctor.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Centre immediately.

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so 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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

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 (issues with liver function).

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your safety and well-being are the top priorities, and your healthcare provider is there to help you navigate your treatment plan.

Storage and Handling

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

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of minor aches and pain of muscles and joints associated with conditions like 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, applying it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it without consulting a doctor.

Are there any warnings for using this product?

Yes, this product is for external use only. Avoid getting it into the 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.

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

You should ask a health professional before using this product if you are pregnant or breastfeeding.

What should I do if this product is swallowed?

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

How should I store this product?

Store this product 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 available in two packaging sizes: a 24 ml unit box with NDC 60954-014-24 and a 36 ml unit box with NDC 60954-014-36. Each unit box contains the specified volume of the formulation, designed for professional use.

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 performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, the product should not be used without consulting a healthcare professional.

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

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 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 should be aware that this product is 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 and should use it only 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 are advised to discontinue use and consult a healthcare professional.

For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional prior to use.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical assistance or contact a Poison Control Centre immediately.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations 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; consultation with a healthcare professional is advised. 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 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 on 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 not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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.

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 monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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. 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, as this may lead to irritation or adverse effects. Additionally, they should be instructed not to apply the product to wounds or damaged skin to prevent complications. Healthcare providers should emphasize the importance of not bandaging the area tightly after application, as this may affect the product's efficacy and safety. Finally, patients must be reminded to use the product only as directed and not to deviate from the recommended usage instructions.

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.