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Eagle

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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)
Marketed in the U.S.
Since 2022
Label revision date
October 2, 2024
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
Marketed in the U.S.
Since 2022
Label revision date
October 2, 2024
Manufacturer
Eagle Indo Pharma, PT
Registration number
M017
NDC root
60954-007

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Drug Overview

This medication is designed to temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for conditions such as simple backache, strains, bruises, and sprains. If you're experiencing discomfort from these common issues, this drug may provide the relief you need to feel more comfortable.

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 common issues such as simple backaches, strains, bruises, and sprains.

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

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If your child is under 2 years old, it's best to consult with a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always prioritize safety and follow the instructions provided by your healthcare professional.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this could lead to irritation or other complications. Additionally, avoid using it in conjunction with a heating pad, as this may increase the risk of adverse effects.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, don't hesitate to reach out for more information.

Side Effects

You should use this product only on the skin and be aware of some important warnings. If your condition worsens, symptoms last longer than 7 days, or if you experience excessive skin irritation, stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, it's also a good idea to seek medical advice.

Before using the product, talk to your doctor if you notice any redness in the area you plan to treat. This will help ensure that you use the product safely and effectively.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately. Avoid using it on wounds or damaged skin, and do not apply it with a heating pad.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation. Your health and safety are important, so please take these precautions seriously.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance if you have concerns about your health.

Pregnancy Use

Currently, there is no specific information available about the use of Eagle Medicated Aromatic (camphor menthol methyl salicylate oil) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product. They can provide guidance based on your individual health needs and any potential risks.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

If your child is under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no known 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.

Always keep your healthcare provider informed about any changes in your health or new medications you start. They can help you understand how to manage your health safely and effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to maintain its integrity. Once you open the product, be sure to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use.

FAQ

What does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains, bruises, and sprains.

How should I use this drug?

Apply to the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. For children under 2 years, ask a doctor.

Are there any contraindications for this drug?

No contraindications are specified for this drug.

What should I avoid while using this drug?

Do not use on wounds or damaged skin, and do not use with a heating pad.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if excessive skin irritation occurs.

Is this drug safe to use during pregnancy?

There is no specific information regarding the safety of this drug during pregnancy.

What should I do if I accidentally swallow this drug?

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

How should I store this drug?

Store at room temperature, protect from light, and keep tightly closed when not in use. Discard after opening.

Are there any side effects I should be aware of?

For external use only; stop use and ask a doctor if excessive skin irritation occurs or if symptoms clear up and occur again within a few days.

Packaging Info

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

Packaging configurations for Eagle.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including but not limited to simple backache, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be used only as directed. For adults and children aged 2 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse effects. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to increased risk of burns or skin damage.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed when using this product. It should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, the use of a heating pad in conjunction with this product is contraindicated.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

In cases of accidental ingestion, it is crucial to seek emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, it is important to monitor for any adverse reactions that may arise during treatment.

Participants are advised to stop use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs.

Additionally, patients should seek medical advice before using the product if there is redness over the affected area, as this may indicate a more serious underlying condition that requires attention.

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 dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Eagle.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. 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 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information available regarding the use of Eagle Medicated Aromatic (camphor menthol methyl salicylate oil) during pregnancy. As such, the safety of this product in pregnant patients has not been established. There are no known dosage modifications or special precautions recommended for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for women of childbearing potential. It is advisable to exercise caution and to discuss any concerns with patients who are pregnant or planning to become pregnant.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the context of overdosage, it is important to note that there is no specific information available regarding overdosage in the current drug insert. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects or symptoms that may arise. Standard supportive measures should be implemented as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

Given the lack of specific overdosage information, healthcare professionals are encouraged to report any cases of suspected overdosage to the appropriate regulatory authorities and consult with a poison control center for further guidance on management strategies.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to counsel patients to discontinue use and consult a doctor if their condition worsens, or if symptoms persist for more than 7 days. Additionally, patients should be advised to stop using the product and seek medical advice if symptoms improve and then recur within a few days, or if they experience excessive skin irritation.

While using this product, patients must be cautioned to avoid contact with their eyes or mucous membranes. They should also be instructed not to bandage the area tightly. Furthermore, healthcare providers should recommend that patients consult a doctor before using the product if there is redness over the affected area.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

When not in use, the container should be kept tightly closed to ensure the product remains uncontaminated. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Eagle, 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, 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.