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Medicated Green Oil

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This product has been discontinued

Active ingredients
  • Menthol 160 mg/100 mL
  • Methyl Salicylate 300 mg/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 2013
Label revision date
July 2, 2013
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 160 mg/100 mL
  • Methyl Salicylate 300 mg/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 2013
Label revision date
July 2, 2013
Manufacturer
Allways Health-Care Corporation Limited
Registration number
part348
NDC root
55531-001
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

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is commonly used for conditions such as simple backache, arthritis, strains, and sprains. This means that if you're experiencing discomfort from these issues, this drug may help alleviate your pain and improve your comfort.

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 common issues such as simple backaches, arthritis, strains, 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 or your child is 3 years old or older and need to use this medication, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure safe and effective use.

If your child is under 3 years of age, it's important to consult a doctor before using the medication. They can provide the best advice tailored to your child's needs. Always remember to apply the medication only to the specific area that needs treatment.

What to Avoid

It's important to use this medication only as directed by your healthcare provider. Avoid applying it to wounds or damaged skin, as this can lead to complications. Additionally, do not bandage the area tightly after application, as this may interfere with the medication's effectiveness and could cause irritation. Always follow your doctor's instructions to ensure safe and effective use.

Side Effects

When using this product, it's important to apply it only as directed and avoid contact with your eyes or any mucous membranes. You should not use it on wounds or damaged skin, and avoid tightly bandaging the area. If your condition worsens, persists for more than 7 days, or clears up only to return shortly after, stop using the product and consult a doctor. Additionally, if you experience excessive skin irritation, seek medical advice.

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 the Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. Use it exactly as directed, and do not apply it to wounds or damaged skin. When using this product, avoid tightly bandaging the area.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, discontinue use and seek medical advice. Keep this product out of reach of children, and if swallowed, seek medical help or contact the Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately or contact the Poison Control Center. Acting quickly can make a significant difference in managing the situation.

Signs of an overdose may include unusual symptoms, but specific details about these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, your safety is the top priority, so always err on the side of caution.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child 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 3 years old, it's important to consult a doctor before using this medication. For children aged 3 years and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When considering the use of Medicated Green Oil for older adults, it's important to note that the drug insert does not provide specific information about how it may affect this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new medication. They can help ensure that the treatment is safe and appropriate based on individual health 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 should be used 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 determine the best course of action based on your kidney function and overall health.

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 (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool and dry place. The ideal average temperature for storage is 86 degrees Fahrenheit (30 degrees Celsius). This helps maintain the integrity of the device and its components.

When handling the product, always ensure that you do so in a clean environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is this drug used for?

This drug is used for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, and sprains.

How should I apply this drug?

Adults and children 3 years of age and older should apply it to the affected area not more than 3 to 4 times daily. For children under 3 years of age, consult a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I avoid while using this drug?

You should avoid applying it to wounds or damaged skin, bandaging tightly, and contact with eyes or mucous membranes.

What should I do if my condition worsens?

Stop using the product and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if excessive skin irritation develops.

Is this drug safe to use during pregnancy or breastfeeding?

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

What should I do if this drug is swallowed?

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

How should I store this drug?

Store the drug in a cool and dry place at an average temperature of 86 degrees F (30°C).

Packaging Info

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

Packaging configurations for Medicated Green Oil.
Details

Drug Information (PDF)

This file contains official product information for Medicated Green Oil, 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 SPL Code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

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, and sprains.

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

Dosage and Administration

For adults and children aged 3 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. It is important to ensure that the application does not exceed this frequency to avoid potential adverse effects.

In the case of children under 3 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

The product should not be used other than as directed. Application to wounds or damaged skin is contraindicated due to the potential for adverse effects. Additionally, tight bandaging of the area where the product is applied is not recommended, as it may lead to complications.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes and mucous membranes. Users should strictly adhere to the directions provided and refrain from using the product in any manner other than as specified.

When applying this product, it is crucial not to apply it to wounds or damaged skin. Additionally, users should avoid tightly bandaging the area where the product is applied to prevent complications.

In the event that the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional. Users should also stop using the product if excessive skin irritation develops.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

For individuals who are pregnant or breastfeeding, it is recommended to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and awareness. The product is intended for external use only, and contact with the eyes or mucous membranes should be avoided to prevent irritation. It is crucial that patients do not use the product other than as directed.

During the application of this product, patients should refrain from applying it to wounds or damaged skin and should avoid tight bandaging. If patients notice that their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, they should stop use and consult a healthcare professional. Additionally, excessive irritation of the skin may occur, warranting discontinuation of use and medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Furthermore, this product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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

Packaging configurations for Medicated Green Oil.
Details

Pediatric Use

Pediatric patients under 3 years of age should consult a doctor prior to use. For children aged 3 years and older, the recommended application is to the affected area not more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of Medicated Green Oil, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

Due to the absence of clinical findings or recommendations tailored to this population, it is advisable for healthcare providers to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individualized assessment and careful consideration of the patient's overall health status and concurrent medications are recommended to ensure safe and effective use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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. 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 the Poison Control Center 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 management strategy.

Healthcare providers should be prepared to implement supportive care and symptomatic treatment as necessary, based on the clinical presentation of the patient. Continuous monitoring and evaluation may be required to ensure patient safety and effective management of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

In postmarketing experience, serious adverse events have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated contact number at 1-213-618-6868. This information contributes to ongoing safety monitoring and evaluation of the product.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact the Poison Control Center if the product is swallowed. It is important to emphasize that the product should only be used as directed, and patients should refrain from using it in any other manner.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens. Additionally, patients should be informed to stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Patients should also be cautioned to stop use and consult a healthcare professional if they experience excessive skin irritation. It is critical to inform patients that the product should not be applied to wounds or damaged skin. Furthermore, when using the product, patients should avoid tightly bandaging the area of application.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored in a cool and dry place, maintaining an average temperature of 86 degrees Fahrenheit (30 degrees Celsius). Proper storage conditions are essential to ensure the product remains effective and safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medicated Green 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 Medicated Green 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.