Eagle

Description

The product is a topical oil formulated to provide relief from minor aches and pains. It contains a blend of natural oils as active ingredients, complemented by inactive ingredients such as mineral oil, eucalyptus oil, and menthol. The formulation is packaged in a 4 oz bottle. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor muscle and joint pain 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, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

• Application to the eyes or mucous membranes is prohibited due to the potential for irritation or injury.

• The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or hinder healing.

• Tight bandaging of the area where the product is applied is contraindicated, as it may lead to adverse effects or compromised circulation.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a physician if they experience excessive skin irritation. Additionally, if pain worsens or fails to improve within 7 days, or if symptoms resolve only to reappear shortly thereafter, it is essential to stop use and seek medical advice. Monitoring for these adverse effects is crucial to ensure patient safety and effective management of their condition.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, it is important to monitor for signs of excessive skin irritation. If such irritation develops, or if pain worsens or does not improve within 7 days, or if symptoms clear up and then reappear within a few days, patients are advised to stop use and consult a healthcare professional. These recommendations are based on clinical observations and are crucial for ensuring patient safety and effective management of adverse reactions.

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

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 specific information regarding the use of Eagle Medicated Oil (menthol methyl salicylate oil) during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential, as the absence of data precludes a definitive assessment of risks or fetal outcomes. It is advisable to consider the potential benefits and risks before use in this population.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Eagle Medicated Oil. Therefore, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. 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 discontinue use and consult a doctor if they experience excessive skin irritation. Additionally, they should be advised to stop using the product and seek medical advice if their pain worsens or does not improve within 7 days, or if the condition clears up and then reappears within a few days.

It is essential to emphasize that patients must use this product only as directed. They should be cautioned against getting the medication into their eyes or mucous membranes. Furthermore, patients should not apply the product to wounds or damaged skin, and they should avoid tightly bandaging the area where the product is applied.

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

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a doctor before use. No further information is 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)