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Extra Strength

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Active ingredients
  • Menthol 94.41 mg/1 mL
  • Methyl Salicylate 123.74 mg/1 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 2019
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 94.41 mg/1 mL
  • Methyl Salicylate 123.74 mg/1 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 2019
Label revision date
December 17, 2024
Manufacturer
NATURES FORMULAE HEALTH PRODUCTS LTD.
Registration number
M017
NDC root
69204-027
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

Extra Strength Pain Relieving Oil Blend is a topical product designed to provide temporary relief from minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains.

This oil blend works by soothing discomfort in the affected areas, allowing you to feel more comfortable and active throughout your day.

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 associated with these common issues, allowing you to get back to your daily activities with less pain. Remember, while it can help with these specific conditions, it's always a good idea to consult with a healthcare professional if you have any concerns.

Dosage and Administration

You should apply the medication to the affected area of your skin no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. If you have any questions about how to use the medication or if you experience any issues, don’t hesitate to reach out to your healthcare provider for guidance.

What to Avoid

You should avoid using this product if you are allergic to plants in the asteraceae/compositae/daisy family, as this could trigger an allergic reaction. Additionally, do not apply it to wounds or damaged skin, and be careful not to bandage the area tightly, as this could cause further issues. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your health and safety.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any wounds or damaged skin. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Centre immediately.

If you have allergies to plants in the asteraceae/compositae/daisy family, do not use this product. Additionally, avoid tightly bandaging the area where you apply it. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. Unfortunately, there is no specific information available about the signs or symptoms of an overdose for this medication. However, if you experience unusual symptoms or feel unwell after taking the medication, you should seek medical help right away.

In any case of suspected overdose, contacting a healthcare professional or poison control center is crucial. They can provide guidance on what to do next and help ensure your safety. Always remember that it's better to be cautious and get help if you're unsure.

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 professional 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

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Centre. Taking quick action is crucial to ensure their safety. Always supervise the use of medications around children to prevent any accidents.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 any tests you may be undergoing.

Storage and Handling

To ensure the best use of your product, store it at room temperature. This helps maintain its effectiveness and safety. Before using, always check that the security seal around the bottle is intact. If the seal is broken or missing, do not use the product, as this may indicate that it has been compromised. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Extra Strength Pain Relieving Oil Blend used for?

It is used for the temporary relief of minor aches and pains of muscles and joints associated with simple back ache, arthritis, strains, bruises, and sprains.

How should I apply Extra Strength Pain Relieving Oil Blend?

You should apply it to the affected area no more than 3 to 4 times daily.

Are there any contraindications for using this product?

Do not use it if you are allergic to plants of the asteraceae/compositae/daisy family, on wounds or damaged skin, or if the security seal around the bottle is broken or missing.

What should I do if I experience worsening symptoms?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is this product safe for use during pregnancy or breastfeeding?

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

What precautions should I take when using this product?

For external use only; avoid contact with eyes and mucous membranes. If contact occurs, rinse with vegetable oil.

What should I do if the product is swallowed?

Keep it out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away.

How should I store Extra Strength Pain Relieving Oil Blend?

Store it at room temperature.

Packaging Info

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

Packaging configurations for Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation is an Extra Strength Pain Relieving Oil Blend, provided in a dosage form of 1.5 fluid ounces (45 milliliters). The product is designed for topical application to alleviate pain.

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

The recommended dosage for adults is to apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is performed gently and that the affected area is clean and dry prior to administration. Healthcare professionals should advise patients to avoid applying the medication to broken or irritated skin unless directed by a physician. Regular monitoring of the treatment area is recommended to assess for any adverse reactions or the need for dosage adjustment.

Contraindications

Use is contraindicated in individuals with a known allergy to plants of the Asteraceae/Compositae/Daisy family due to the potential for severe allergic reactions.

Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to complications. Tight bandaging of the area where the product is applied is also contraindicated to prevent impaired circulation and potential tissue damage.

Warnings and Precautions

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

This product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to further complications. Additionally, it is advised not to bandage the area tightly, as this could impede proper healing and increase the risk of adverse effects.

Healthcare professionals should be aware that individuals with known allergies to plants of the Asteraceae/Compositae/Daisy family should avoid using this product to prevent allergic reactions.

Patients should be instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective treatment.

Side Effects

For external use only. Patients should stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

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

Packaging configurations for Extra Strength.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is recommended.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding considerations.

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 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 clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In the context of overdosage, it is important to note that there is currently no information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to exercise caution and consider the lack of specific data when addressing potential overdosage scenarios.

In the absence of detailed guidance, it is recommended that healthcare providers monitor patients closely for any unusual symptoms or adverse effects that may arise. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation of the patient.

In cases of suspected overdosage, it is prudent to consult local poison control centers or relevant medical authorities for further assistance and 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the extracted data.

Patient Counseling

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

Patients should be informed not to use the product on wounds or damaged skin and to avoid bandaging the area tightly. It is important to discuss the potential for allergic reactions; patients should not use the product if they are allergic to plants in the asteraceae/compositae/daisy family.

Healthcare providers should counsel patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be cautioned to avoid contact with eyes and mucous membranes; if contact occurs, they should rinse the affected area with vegetable oil.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to ensure that the security seal around the bottle remains intact; the product should not be used if the seal is broken or missing.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength, 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 Extra Strength, 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.