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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
October 24, 2025
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
October 24, 2025
Manufacturer
Saje Natural Business Inc.
Registration number
M017
NDC root
70983-023
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 used for conditions such as simple backache, arthritis, strains, bruises, and sprains. This oil blend is available in two sizes: 0.68 fl oz (20 ml) and 1.5 fl oz (45 ml), making it convenient for various needs.

By applying this oil to the affected area, you can help alleviate discomfort and support your mobility.

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 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

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 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 keep it out of reach of children. If the product is swallowed, seek medical help or contact a Poison Control Centre immediately. Avoid using it on wounds or damaged skin, and do not apply a tight bandage over the area.

If you have an allergy to plants in the asteraceae/compositae/daisy family, do not use this product. You should stop using it and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Be careful to avoid contact with your eyes and mucous membranes; if contact occurs, rinse the area with vegetable oil.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it’s better to err on the side of caution and get help.

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

It's important to keep this product out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Centre for assistance. Taking quick action can help ensure their safety. Always be vigilant about where medications and potentially harmful substances are stored in your home.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination.

If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use or storage. Always dispose of any used materials according to local regulations to ensure safety and environmental responsibility.

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 conditions like 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.

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.

Can I use this product if I am pregnant 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?

Avoid contact with eyes and mucous membranes; if contact occurs, rinse with vegetable oil. Do not use on wounds or damaged skin, and do not bandage tightly.

How should I store Extra Strength Pain Relieving Oil Blend?

Store it at room temperature and keep it out of reach of children.

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

No description information is available for the specified drug.

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 back ache, 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 skin or open wounds. 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. It is also contraindicated to bandage the area tightly after application, which could impede circulation and cause further issues.

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. Additionally, it is advised not to bandage the area tightly after application. Healthcare professionals should be aware that individuals with known allergies to plants of the Asteraceae/Compositae/Daisy family should refrain from using this product.

Patients are advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Care should be taken to avoid contact with the eyes and mucous membranes. In the event of such contact, it is recommended to rinse the affected area with vegetable oil.

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

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 on 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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 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 of 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. In the event of such contact, they should rinse the affected area with vegetable oil.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

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.