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Pain Relieving Balm

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This product has been discontinued

Active ingredients
  • Menthol 7.6 g/100 g
  • Methyl Salicylate 29 g/100 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
July 24, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 7.6 g/100 g
  • Methyl Salicylate 29 g/100 g
Other brand names
Dosage form
Liquid
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 2011
Label revision date
July 24, 2018
Manufacturer
TopCo
Registration number
part348
NDC root
36800-738
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 medication is designed to temporarily relieve minor pain. It can be helpful for various conditions, including arthritis, simple backaches, muscle strains, bruises, muscle sprains, and cramps. By targeting the source of discomfort, it aims to provide you with some relief from these common aches and pains.

Uses

You can use this medication to temporarily relieve minor pain from various conditions. If you're dealing with arthritis, simple backaches, muscle strains, bruises, muscle sprains, or cramps, this medication may help ease your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard. Always consult with your healthcare provider for personalized advice and to ensure this treatment is right for you.

Dosage and Administration

For adults and children over 12 years old, you should apply the medication generously to the area that is causing you pain. After applying, gently massage it into your skin until it is fully absorbed. You can repeat this process as needed, but make sure not to apply it more than four times in a single day.

If you are considering using this medication for a child under 12 years old, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (a condition where your body becomes reliant on a substance) associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms persist for more than seven days or return shortly after improvement. Additionally, if you have a history of allergic reactions to aspirin or salicylates, it's best to talk to your doctor before using this product.

Remember, this product is for external use only. Avoid contact with your eyes or mucous membranes, and do not apply it to wounds or damaged skin. It's also advised not to bandage tightly or use it with a heating pad. If you are pregnant or breastfeeding, please consult a healthcare professional before use.

Warnings and Precautions

This product is for external use only. If you have a history of allergic reactions to aspirin or salicylates, please consult your doctor before using it. When applying this product, make sure to follow the instructions carefully. Avoid getting it in your eyes or on mucous membranes, and do not apply it to wounds or damaged skin. It's also important not to bandage the area tightly or use a heating pad with it.

You should stop using the product and contact your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last longer than 7 days or return after clearing up. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their age and health needs.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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. This means that the information available does not provide special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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 to manage your treatment effectively.

Hepatic Impairment

If you have liver 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 standard dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health. Regular liver function tests (which check how well your liver is working) may also be recommended to monitor your condition. Always keep your doctor informed about your liver health when discussing treatment options.

Drug Interactions

It's important to talk to your healthcare provider before using this medication, especially if you have a history of allergic reactions to aspirin or salicylates (a group of drugs that includes aspirin). Your doctor can help determine if this medication is safe for you.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always a good practice to discuss all medications and tests you are undergoing with your healthcare provider. This ensures your safety and helps avoid any potential issues.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in a day. If the user is under 12 years old, consult a doctor before use.

Be aware of a few important safety tips: If you have a history of allergic reactions to aspirin or salicylates, talk to your doctor before using this product. If you are pregnant or breastfeeding, it's best to consult a healthcare professional. Always keep the medication out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug is used to temporarily relieve minor pain associated with conditions like arthritis, simple backache, muscle strains, bruises, muscle sprains, and cramps.

How should adults and children over 12 use this drug?

Apply generously to the affected area and massage it into the skin until thoroughly absorbed. You can repeat this process as necessary, but do not exceed 4 times daily.

What should children under 12 do before using this drug?

Children under 12 years should ask a doctor before use.

Are there any warnings associated with this drug?

Yes, it is for external use only. Avoid contact with eyes or mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I swallow this drug?

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

What should I do if my condition worsens or irritation develops?

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

Is this drug safe to use during pregnancy or breastfeeding?

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

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Pain Relieving Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by the code 51945-4 and is associated with the effective date of July 24, 2018. It is presented in a dosage form that is visually represented in an accompanying image. The image is in JPEG format and is referenced as "label.jpg." Further details regarding the chemical composition, molecular weight, or inactive ingredients are not provided in the extracted data.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, bruises, muscle sprains, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, the recommended dosage is to apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to consult a doctor prior to use if they have a history of allergic reactions to aspirin or salicylates.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Patients should be cautioned to avoid contact with the eyes and mucous membranes. Additionally, it is important to avoid tightly bandaging the area of application or using the product in conjunction with a heating pad. The product should not be applied to wounds or damaged skin to prevent adverse effects.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, medical consultation is also recommended.

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

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware that it is for external use only. An allergy alert is in place for individuals who are prone to allergic reactions from aspirin or salicylates; such patients should consult a doctor prior to use.

When utilizing this product, it is imperative to follow the directions provided. Patients should avoid contact with the eyes or mucous membranes and should not bandage the area tightly or use it in conjunction with a heating pad. Additionally, the product should not be applied to wounds or damaged skin.

Patients are advised to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days or resolve and then recur within a few days. Furthermore, pregnant or breastfeeding patients should seek guidance from a healthcare professional before using this product.

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.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Pain Relieving Balm.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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.

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 healthcare 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities to contribute to the ongoing evaluation of the safety profile of the medication.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no nonclinical toxicology data or animal pharmacology and toxicology information available in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that if the medication is swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately. This information is vital for ensuring patient safety and prompt intervention in case of accidental ingestion.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded after use to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with adults and children over 12 years advised to apply it generously to the affected area and massage until fully absorbed, with a maximum frequency of four times daily. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients on important safety information, including an allergy alert for those sensitive to aspirin or salicylates, and the necessity of consulting a healthcare professional if pregnant or breastfeeding. It is crucial to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Drug Information (PDF)

This file contains official product information for Pain Relieving 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 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

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.