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Pain Relieving Warming Balm

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 1.25 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Gel
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
February 8, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 1.25 g/100 g
  • Methyl Salicylate 10 g/100 g
Other brand names
Dosage form
Gel
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
February 8, 2024
Manufacturer
J. R. Watkins, LLC.
Registration number
M017
NDC root
72342-030
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

This product is a warming balm that provides fast-acting and long-lasting relief from minor aches and pains in muscles and joints. It contains natural menthol and methyl salicylate, which work together to temporarily alleviate discomfort associated with conditions like simple backaches, strains, bruises, sprains, and arthritis.

With a formulation that is 99% natural, this balm has been trusted since 1868 and is designed to help you feel more comfortable and active. Whether you're dealing with everyday muscle soreness or joint pain, this remedy aims to support your body's needs effectively.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, strains, bruises, sprains, and arthritis. This means that if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your mobility.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

It's important to use this medication only as directed by your healthcare provider. If you are an adult or a child aged 3 years and older, you can apply it to the affected area up to 3 to 4 times a day. Make sure to follow the recommended frequency to ensure safety and effectiveness.

If your child is under 3 years old, it's best to consult with a doctor before using this medication. They can provide guidance on the appropriate use for younger children. Always prioritize safety and follow the instructions provided by your healthcare professional.

What to Avoid

It's important to use this product safely to avoid any complications. You should never apply it to wounds or damaged skin, and avoid using it in conjunction with a heating pad, as this can lead to adverse effects.

While using this product, be careful to keep it away from your eyes, nostrils, and mouth. Additionally, do not wrap or bandage the area tightly, as this can cause further issues. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

If you have a history of allergic reactions to aspirin or salicylates, it's important to consult your doctor before using this product. While using it, avoid applying it to wounds or damaged skin, and do not use it with a heating pad. Be careful to keep it away from your eyes, nostrils, and mouth, and avoid wrapping the area tightly.

You should stop using the product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, if they improve and then return within a few days, if you develop a rash or irritation, or if you are taking anticoagulant medications (which are drugs that help prevent blood clots). If you are pregnant or breastfeeding, consult a healthcare professional before use. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. If you have a history of allergic reactions to aspirin or salicylates, consult your doctor before using it. While using this product, be careful to keep it away from your eyes, nostrils, and mouth, and do not use it with a heating pad or bandage it tightly.

You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, if symptoms improve and then return within a few days, if you develop a rash or irritation, or if you are taking anticoagulant medications (blood thinners). If you are pregnant or breastfeeding, it's important to consult a health professional before use. Always keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose has occurred.

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 in a day. Always follow these guidelines to ensure your child's safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. 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, especially if you have any concerns about your kidney health. They can provide guidance based on your individual situation.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to be aware of potential interactions with other medications when considering treatment. If you have a history of allergic reactions to aspirin or salicylates, it's crucial to talk to your doctor before using this medication. Additionally, if you are currently taking anticoagulant medications (which help prevent blood clots), you should stop using this product and consult your healthcare provider.

Always discuss any medications or tests you are undergoing with your healthcare provider to ensure your safety and the effectiveness of your treatment. Your health is a priority, and open communication with your doctor can help prevent any adverse effects.

Storage and Handling

It's important to handle and store your product safely to ensure its effectiveness. First, always check that the tamper-evident seal is intact before use; if it’s broken, do not use the product. Store it in a dry, well-ventilated area at room temperature, ideally between 59°F and 77°F (15°C to 25°C).

Additionally, keep the product out of reach of children to prevent any accidental exposure. Following these guidelines will help maintain the product's quality and safety for your use.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 3 years and older. If your child is under 3 years old, consult a doctor before use.

Before using this medication, it's important to talk to your doctor if you have a history of allergic reactions to aspirin or salicylates. Additionally, if you are pregnant or breastfeeding, seek advice from a healthcare professional before using this product.

FAQ

What is the general description of this product?

This product is a 99% natural, pain-relieving warming balm that contains natural menthol and methyl salicylate, providing fast-acting and long-lasting pain relief.

What conditions does this product temporarily relieve?

It temporarily relieves minor aches and pains of muscles and joints associated with simple backache, strains, bruises, sprains, and arthritis.

How should I use this product?

Apply to the affected area not more than 3-4 times daily for adults and children 3 years and older. For children under 3 years, consult a doctor.

Are there any contraindications for this product?

Do not use this product on wounds or damaged skin, and do not use it with a heating pad.

What should I avoid while using this product?

Avoid contact with eyes, nostrils, and mouth, and do not bandage tightly.

What should I do if I experience side effects?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience rash or irritation.

Is this product safe to use during pregnancy or breastfeeding?

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

What should I do if the product is swallowed?

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

Packaging Info

Below are the non-prescription pack sizes of Pain Relieving Warming Balm (methyl salicylate and menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relieving Warming Balm.
Details

Drug Information (PDF)

This file contains official product information for Pain Relieving Warming Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is a pain-relieving balm formulated with 99% natural ingredients. Established in 1868 by J.R. Watkins, it is designed to provide fast-acting and long-lasting relief from discomfort. The balm contains natural menthol and methyl salicylate, which contribute to its warming effect. It is packaged in a net weight of 3.3 ounces (93 grams).

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, strains, bruises, sprains, and arthritis.

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

Dosage and Administration

The medication should be used only as directed. For adults and children aged 3 years and older, it is recommended to apply the product to the affected area no more than 3 to 4 times daily. For children under 3 years of age, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Application on wounds or damaged skin is prohibited due to the potential for irritation and adverse reactions. Additionally, the use of this product in conjunction with a heating pad is contraindicated, as it may lead to excessive heat and increase the risk of burns or skin damage.

Healthcare professionals should also advise patients to avoid contact with the eyes, nostrils, and mouth to prevent irritation. Furthermore, tight bandaging is not recommended, as it may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a known allergy to aspirin or salicylates. This precaution is critical to prevent potential allergic reactions.

The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects. Additionally, it is contraindicated to use this product in conjunction with a heating pad, as this may increase the risk of burns or other complications.

While using this product, it is essential to avoid contact with the eyes, nostrils, and mouth to prevent irritation or injury. Furthermore, patients should be instructed not to apply tight bandages over the treated area, as this may impede circulation and lead to further complications.

Patients should be advised to discontinue use and seek medical advice 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, a rash or irritation develops, or if they are taking anticoagulant medications.

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

Finally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. Individuals with a known allergy to aspirin or salicylates are advised to consult a healthcare professional prior to use. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad.

During the use of this product, patients should avoid contact with the eyes, nostrils, and mouth, and should refrain from tightly bandaging the area of application.

Patients are instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement within a few days, development of a rash or irritation, or if they are taking anticoagulant medications.

Additional considerations include consulting a healthcare professional if pregnant or breastfeeding. It is also crucial to keep the product out of reach of children; in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to using this medication, as there is a potential risk of allergic reactions.

In patients currently receiving anticoagulant therapy, it is advised to discontinue use of this medication and seek medical advice. The combination may increase the risk of bleeding or other adverse effects associated with anticoagulants. Monitoring of coagulation parameters may be warranted in such cases.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relieving Warming Balm (methyl salicylate and menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relieving Warming Balm.
Details

Pediatric Use

Pediatric patients under 3 years of age should consult a healthcare professional before use. For children aged 3 years and older, the medication may be applied 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

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 medication 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 relation to this drug. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 insert.

Patient Counseling

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

Patients should be informed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, patients should be made aware to stop using the product and seek medical advice if they experience any rash or irritation. Those taking anticoagulant medications should also be advised to consult a doctor before using this product.

While using the product, patients should be cautioned to avoid contact with the eyes, nostrils, and mouth. Furthermore, they should be instructed not to bandage the area tightly when applying the product.

Storage and Handling

The product is supplied with a tamper-evident seal; it should not be used if this seal is not intact. It is essential to store the product away from children to ensure safety. The recommended storage conditions are in a dry, well-ventilated area at room temperature, specifically between 59°F and 77°F. Proper handling and storage are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3-4 times daily for adults and children aged 3 years and older. For children under 3 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to consult a healthcare professional if they have a history of allergic reactions to aspirin or salicylates before using the product. Additionally, pregnant or breastfeeding patients are encouraged to seek advice from a health professional prior to use.

Drug Information (PDF)

This file contains official product information for Pain Relieving Warming Balm, 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 Pain Relieving Warming Balm, 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

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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.