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Josephs Lion Pain Relieving

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Active ingredients
  • Camphor (synthetic) 5 g/100 mL
  • Menthol 8 g/100 mL
  • Methyl Salicylate 10 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 2020
Label revision date
November 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 5 g/100 mL
  • Menthol 8 g/100 mL
  • Methyl Salicylate 10 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 2020
Label revision date
November 10, 2025
Manufacturer
MADISON ONE ACME INC
Registration number
M017
NDC root
55614-680
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

JOSEPH’S LION PAIN RELIEVING OIL is an external analgesic, which means it is designed to relieve pain when applied to the skin. You can use this oil for the temporary relief of minor aches and pains in your muscles and joints caused by conditions such as simple backache, arthritis, strains, bruises, and sprains.

This product comes in a 1.69 fluid ounce (50 mL) bottle, making it easy to apply directly to the affected areas for soothing relief.

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 from these common issues, allowing you to get back to your daily activities with less pain. Remember, it's designed for short-term use to help manage these minor ailments.

Dosage and Administration

If you are an adult or a child aged 3 years and older, you can apply several drops of the medication directly to the affected area. Make sure to rub it in gently, and you can do this up to 3 to 4 times a day.

For children under 3 years of age, it’s important to consult your physician (doctor) before using this medication to ensure it’s safe and appropriate for them. Always follow your healthcare provider's advice for the best results.

What to Avoid

You should avoid using this product on irritated or damaged skin, as well as on any wounds. It’s important to follow the directions provided and not to use it in any other way. Be careful to keep it away from your eyes and mucous membranes, and do not apply tight bandages over the area. Additionally, avoid using heat sources like heating pads, hot water bottles, or lamps on the treated area, as this can significantly increase the risk of serious burns.

Side Effects

If you experience any worsening of your condition, persistent symptoms lasting more than 7 days, or if symptoms clear up only to return within a few days, it's important to stop using the product and consult a doctor. You should also seek medical advice if you notice excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

Additionally, if you feel actual pain, blistering, or burning after application (a warming or cooling sensation is normal), or if you are using the product for arthritis pain and it persists for more than 10 days, is accompanied by redness, or if you are treating a child under 12 years of age, please contact your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any irritated or damaged skin, as well as on open wounds.

If you notice that your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. You should also reach out to your healthcare provider if you experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. If you feel actual pain, blistering, or burning after application (a warming or cooling sensation is normal), or if you are using it for arthritis pain that persists for more than 10 days, has redness, or if it’s for a child under 12, please stop use and call your doctor.

Keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately.

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 an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during this time.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication to ensure it’s safe for you and your baby.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). This means that if you are breastfeeding or planning to breastfeed, it’s important to consult with your healthcare provider for personalized advice. They can help you weigh the benefits and risks based on your individual situation. Always prioritize your health and your baby's well-being when making decisions about medication during breastfeeding.

Pediatric Use

If your child is under 3 years old, it's important to consult your physician before using this medication. For children aged 3 years and older, you can apply several drops to the affected area, but be sure not to exceed 3 to 4 applications per day.

If your child is under 12 years old and experiences pain that lasts more than 10 days or shows signs of redness, you should seek medical advice. These precautions help ensure your child's safety and well-being while using the medication.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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. 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 share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, always keep the container tightly closed when not in use. Store it in a cool, dark place, ideally at a temperature between 15 to 30°C (59 to 86°F). This will help protect the product from light and maintain its quality.

Handling the product safely is crucial. Make sure to follow any specific instructions provided for use, and always check that the container is secure before opening. Proper storage and handling will help you get the best results while ensuring your safety.

Additional Information

For adults and children aged 3 years and older, you should apply several drops of the product to the affected area and rub it in, but do this no more than 3 to 4 times a day. If your child is under 3 years old, it's important to consult your physician before use.

Be sure to report any unexpected side effects to the FDA MedWatch Program. Keep this product out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is JOSEPH’S LION PAIN RELIEVING OIL used for?

JOSEPH’S LION PAIN RELIEVING OIL is used for the temporary relief of minor aches and pains of muscles and joints due to conditions like simple backache, arthritis, strains, bruises, and sprains.

How should I use JOSEPH’S LION PAIN RELIEVING OIL?

For adults and children 3 years of age and older, apply several drops and rub into the affected area not more than 3 to 4 times daily. Consult your physician for children under 3 years of age.

Are there any contraindications for using this product?

Do not use JOSEPH’S LION PAIN RELIEVING OIL on irritated or damaged skin, or on wounds.

What should I do if I experience adverse reactions?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience excessive skin irritation, nausea, or blistering after application.

Is this product safe for use during pregnancy?

No specific information regarding the use of JOSEPH’S LION PAIN RELIEVING OIL during pregnancy is provided, and there are no known teratogenic effects.

What precautions should I take when using this product?

Avoid contact with eyes or mucous membranes, do not bandage tightly, and do not apply heat to the area as it increases the risk of burns.

What should I do if the product is swallowed?

Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center immediately.

How should I store JOSEPH’S LION PAIN RELIEVING OIL?

Store the product tightly closed and protected from light at a temperature between 15 to 30°C (59 to 86°F).

Packaging Info

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

Packaging configurations for Josephs Lion Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Josephs Lion Pain Relieving, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for 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 3 years and older, the recommended dosage is to apply several drops of the product to the affected area and rub it in gently. This application may be performed up to 3 to 4 times daily, ensuring that the total number of applications does not exceed this frequency.

For children under 3 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

Use of this product is contraindicated in the following situations:

Application on irritated or damaged skin is prohibited due to the potential for exacerbating the condition. Additionally, the product should not be applied to open wounds, as this may lead to further complications.

The product must not be used contrary to the provided directions. Contact with the eyes or mucous membranes should be avoided to prevent irritation or injury. Tight bandaging of the application site is contraindicated, as it may impede circulation. Furthermore, the application of heat in the form of heating pads, hot water bottles, or lamps is not recommended, as it significantly increases the risk of serious burns.

Warnings and Precautions

For external use only. This product is contraindicated for application on irritated or damaged skin and should not be used on open wounds.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens; symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; excessive skin irritation develops; gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest; or if the patient experiences actual pain, blistering, or burning following application. It is important to note that while a warming or cooling sensation may be expected, any significant discomfort should be evaluated.

In cases where the product is used for arthritis-related pain, patients should be instructed to consult a healthcare provider if pain persists for more than 10 days, if redness is observed, or if the product is being used on children under 12 years of age.

To prevent accidental poisoning, this product should 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 recommended.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms for more than 7 days, recurrence of symptoms after they have cleared within a few days, or development of excessive skin irritation. Additionally, patients should seek medical advice if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

It is important to note that while a warming or cooling sensation may be expected after application, patients should report any actual pain, blistering, or burning sensations. For those using the product for arthritis-related pain, they should stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Josephs Lion Pain Relieving.
Details

Pediatric Use

Pediatric patients under 3 years of age should consult a physician prior to use. For children aged 3 years and older, the recommended application is several drops rubbed into the affected area, not exceeding 3 to 4 times daily.

In children under 12 years of age, if pain persists for more than 10 days or if redness is present, medical advice should be sought.

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 should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals are encouraged to consider the absence of data when advising women of childbearing potential and to weigh the potential benefits against any unknown risks when prescribing this product to pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific antidotes or additional management strategies tailored to the substance involved.

Monitoring should continue until the patient is stable and any potential complications are addressed. Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is critical for ongoing management and future reference.

Healthcare professionals are encouraged to familiarize themselves with local protocols and guidelines regarding overdose management to ensure prompt and effective intervention.

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

Reports of unexpected side effects associated with the use of this product have been received through voluntary submissions and surveillance programs. Healthcare professionals and consumers are encouraged to report any adverse events to the FDA MedWatch Program. Serious side effects can also be reported by contacting the designated phone number at 888-221-3496, available Monday through Friday from 9 am to 5 pm.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on irritated or damaged skin, and it should not be applied to open wounds. They should be informed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, excessive skin irritation develops, or if they experience nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. Additionally, patients should seek medical advice if they feel actual pain or experience blistering or burning after application, noting that a warming or cooling sensation is expected.

For those using the product for arthritis pain, it is important to inform them to stop use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used for conditions affecting children under 12 years of age.

While using this product, patients should be reminded to follow the directions carefully and avoid using it in any manner other than as directed. They should take care to avoid contact with the eyes or mucous membranes, refrain from tightly bandaging the area, and not apply heat through heating pads, hot water bottles, or lamps, as this may increase the risk of serious burns.

Patients should also be encouraged to consult a doctor or pharmacist if they have any concerns regarding the use of this product.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored protected from light within a temperature range of 15 to 30°C (59 to 86°F) to ensure optimal stability and efficacy.

Additional Clinical Information

Patients aged 3 years and older are advised to apply several drops of the product to the affected area, rubbing it in no more than 3 to 4 times daily. For children under 3 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to report any unexpected side effects to the FDA MedWatch Program. It is crucial to keep the product out of reach of children to prevent accidental poisoning; if ingested, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Josephs Lion Pain Relieving, 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 Josephs Lion Pain Relieving, 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.

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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.