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Eagle Medicated Oil

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Active ingredients
  • Menthol 14 g/100 mL
  • Methyl Salicylate 15 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 2022
Label revision date
October 6, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 14 g/100 mL
  • Methyl Salicylate 15 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 2022
Label revision date
October 6, 2024
Manufacturer
Eagle Indo Pharma, PT
Registration number
M017
NDC root
60954-005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, strains, bruises, and sprains. This means if you’ve had a minor injury or are experiencing discomfort in these areas, this medication may help ease your pain.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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. Do not apply it to wounds or damaged skin, and avoid using it with a heating pad, as this can increase the risk of side effects. When using the product, make sure to keep it away from your eyes and mucous membranes, and do not wrap the area tightly with a bandage.

Additionally, please keep this product out of reach of children to prevent accidental poisoning. If a child swallows it, seek medical help or contact a Poison Control Center immediately. Your safety is a priority, so following these guidelines is essential.

Side Effects

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

Before using this product, talk to your doctor if you notice any redness in the area you plan to treat. Your health and safety are important, so don’t hesitate to reach out for guidance if you have any concerns.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Keep it out of reach of children to prevent accidental poisoning. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms improve and then return within a few days, or if you experience excessive skin irritation. Always prioritize your safety and well-being.

Overdose

If you suspect an overdose, it's important to be aware that there are no specific details provided about what to expect or how to respond. However, general signs of an overdose can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek immediate medical help. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

Pregnancy Use

Currently, there is no information available about the use of Eagle Medicated Oil Refreshing during pregnancy. This means that there are no specific safety concerns, dosage adjustments, or special precautions outlined for pregnant individuals. If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during lactation (the period of breastfeeding). This means that the effects on breast milk and nursing infants have not been clearly studied or documented.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best course of action based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can help you understand how your kidney function may affect your medication and what steps to take for your safety.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

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 drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple steps 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 your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What conditions 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 warnings for using this drug?

Yes, it is for external use only. Do not use on wounds or damaged skin, and avoid contact with eyes or mucous membranes.

What should I do if my condition worsens?

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

What should I do if I accidentally swallow this drug?

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

Is this drug safe to use during pregnancy or while nursing?

There is no specific information provided regarding use during pregnancy or nursing mothers.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Eagle Medicated Oil.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a topical solution formulated with 5% menthol. It appears as a clear, colorless to pale yellow liquid. The inactive ingredients consist of alcohol, water, glycerin, propylene glycol, aloe vera extract, and fragrance. The SPL code for this product is 34089-3.

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, it is advised to consult a physician prior to use.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and delayed healing. Additionally, the application of this product in conjunction with a heating pad is not recommended, as it may increase the risk of skin irritation or burns.

Contact with the eyes or mucous membranes should be strictly avoided, as this may lead to significant discomfort or injury. Furthermore, tight bandaging after application is contraindicated, as it may impede circulation and exacerbate local irritation.

To prevent accidental poisoning, the product must be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 include avoiding application on wounds or damaged skin, as this may exacerbate irritation or lead to complications. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may increase the risk of adverse effects.

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

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 Medicated Oil (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Eagle Medicated Oil.
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 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 information available regarding the use of EAGLE MEDICATED OIL REFRESHING during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should exercise caution and consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, no data are provided concerning the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 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 absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution when administering the medication.

It is essential to monitor patients closely for any signs of adverse reactions or symptoms that may arise from excessive dosing. In the event of suspected overdosage, immediate medical attention should be sought.

Healthcare providers should implement standard supportive measures, which may include symptomatic treatment and monitoring of vital signs. Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on management strategies tailored to the specific circumstances of the overdosage event.

Documentation of the incident and any interventions performed is crucial for ongoing patient care and for informing future treatment decisions.

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 text.

Patient Counseling

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

Patients should be informed to avoid contact with the eyes and mucous membranes, as this could lead to irritation or adverse effects. Additionally, healthcare providers should counsel patients not to bandage the area tightly, as this may cause complications or hinder proper healing.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Eagle Medicated Oil, 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 Medicated Oil, 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.