Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Neck and Lumbar Pain Relieving Balm

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredients
  • Camphor (synthetic) 11 g/100 g
  • Menthol 16 g/100 g
  • Methyl Salicylate 30 g/100 g
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
May 18, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 11 g/100 g
  • Menthol 16 g/100 g
  • Methyl Salicylate 30 g/100 g
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
May 18, 2020
Manufacturer
MADISON ONE ACME INC
Registration number
part348
NDC root
55614-660
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

NECK & LUMBAR PAIN RELIEVING BALM is an external analgesic designed to provide temporary relief from minor aches and pains in muscles and joints. It contains key ingredients such as camphor, menthol, and methyl salicylate, which work together to soothe discomfort associated with conditions like simple backache, arthritis, strains, bruises, and sprains.

This balm is easy to use and can be applied directly to the affected area, making it a convenient option for managing pain and promoting comfort in your daily activities.

Uses

If you're experiencing 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 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 way other than as directed. Be cautious 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

You should be aware that this product is for external use only. If your condition worsens, symptoms last more than 7 days, or if they clear up and then return within a few days, it's important to stop using the product and consult a doctor. Additionally, if you experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash, seek medical advice.

If you feel actual pain, blistering, or burning after applying the product (a warming or cooling sensation is normal), or if you're using it for arthritis pain and it persists for more than 10 days, or if you notice redness, you should also contact a healthcare professional. This is especially important for children under 12 years of age.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any wounds or areas of irritated or damaged skin. 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, it's important to stop using the product and consult your doctor. Additionally, if you experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash, you should also reach out to your healthcare provider.

If you feel actual pain, blistering, or burning after applying the product (a warming or cooling sensation is normal), or if you're using it for arthritis pain and it persists for more than 10 days, please contact your doctor. This is especially important for children under 12 years of age.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you take too much of this medication, you may experience symptoms such as nausea (feeling sick), vomiting, abdominal discomfort (stomach pain), diarrhea, or a skin rash. These signs can indicate an overdose, which is when you have taken more than the recommended amount.

If you suspect an overdose, it’s important to seek help immediately. Contact your healthcare provider or go to the nearest emergency room. They can provide the necessary care to address the situation. Always remember, it’s better to be safe and get checked if you notice any unusual symptoms after taking your medication.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available in the drug insert. This means that there are no clear guidelines about whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for adjusting the dosage or taking special precautions if you are pregnant.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no statements about the product being excreted in breast milk or any associated risks for your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

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 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 experiencing arthritis pain and it lasts more than 10 days or if you notice any redness, seek medical advice, especially for children under 12. Always keep this medication out of reach of children to prevent accidental poisoning. If your child accidentally swallows it, contact a medical professional or a Poison Control Center immediately.

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 and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 standard recommendations for the medication do not include 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 medication you take is safe and appropriate for your health situation. They can provide guidance based on your individual needs and kidney function.

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 discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

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 with care is essential. Make sure to follow any additional safety instructions provided with the product to ensure proper use and disposal. By adhering to these guidelines, you can help ensure the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically, using several drops rubbed into the affected area. For adults and children aged 3 years and older, you can do this up to 3 to 4 times daily. If the patient is under 3 years old, it's important to consult a physician first.

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 NECK & LUMBAR PAIN RELIEVING BALM used for?

It 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.

What are the key ingredients in this balm?

The key ingredients are camphor, menthol, and methyl salicylate.

How should I apply the balm?

For adults and children 3 years 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.

Are there any warnings I should be aware of?

Yes, it is for external use only. Avoid contact with eyes or mucous membranes, and do not use on irritated or damaged skin or 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 other severe reactions.

Is this balm safe to use during pregnancy or while nursing?

There are no specific warnings or recommendations regarding use during pregnancy or lactation provided in the product information.

What should I do if the balm is swallowed?

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

How should I store the balm?

Keep the container tightly closed and store it protected from light at temperatures between 15 to 30°C (59 to 86°F).

Packaging Info

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

Packaging configurations for Neck and Lumbar Pain Relieving Balm.
Details

Drug Information (PDF)

This file contains official product information for Neck and Lumbar 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 an external analgesic formulated to relieve neck and lumbar pain. It contains active ingredients including camphor, menthol, and methyl salicylate. The product is packaged in a 2.82 oz (80 g) container, with the National Drug Code (NDC) 55614-660-01.

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 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 any form, including heating pads, hot water bottles, or lamps, is not recommended due to the increased 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: if the condition worsens; if symptoms persist for more than 7 days; if symptoms resolve and then recur within a few days; if excessive skin irritation develops; if gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest; or if the patient experiences actual pain, blistering, or burning after application. It is important to note that a warming or cooling sensation is expected and not a cause for concern.

In cases where the product is used for arthritis-related pain, patients should be instructed to stop use and consult a physician if pain persists for more than 10 days, if redness is observed, or if the patient is under 12 years of age.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that the product is for external use only. In clinical practice, it is advised to stop use and consult a healthcare professional 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, or if excessive skin irritation develops.

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 normal after application, actual pain, blistering, or burning should prompt immediate discontinuation of use and consultation with a healthcare provider.

For patients using the product for arthritis-related pain, it is recommended 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 on children under 12 years of age.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Neck and Lumbar Pain Relieving Balm.
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 cases of arthritis-related pain in children under 12 years, if pain persists for more than 10 days or if redness is present, medical advice should be sought. It is essential to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. 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 should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled on the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to 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 event of an overdosage, patients may present with a range of symptoms including nausea, vomiting, abdominal discomfort, diarrhea, and skin rash.

Healthcare professionals are advised to monitor the patient closely for these symptoms and to initiate appropriate management procedures. Supportive care should be provided as necessary, focusing on symptomatic relief and stabilization of the patient's condition.

In cases of significant overdosage, further medical intervention may be required, and it is recommended to consult a poison control center or a medical toxicologist for guidance on specific treatment protocols.

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 understanding of the compound's potential effects 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. Additionally, serious side effects can be reported via a designated phone number. These reports contribute to the ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. 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 irritated or damaged skin, and it should not be applied to wounds. Healthcare providers should counsel patients 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 normal.

For patients using this product for arthritis pain, they should be advised 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.

When using this product, patients should be instructed to follow the directions carefully and avoid using it in any manner other than as directed. They should be cautioned to avoid contact with the eyes or mucous membranes, not to bandage the area tightly, and to refrain from applying heat to the area, such as with heating pads, hot water bottles, or lamps, as this increases the risk of serious burns.

Finally, healthcare providers should encourage patients 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). Proper storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children aged 3 years and older being several drops rubbed into the affected area up to 3 to 4 times daily. For children under 3 years of age, clinicians are advised to consult a physician prior to use.

Patients should be counseled to report any unexpected side effects to the FDA MedWatch Program. Additionally, it is crucial to keep the product out of reach of children to prevent accidental poisoning; if ingested, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Neck and Lumbar 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 Neck and Lumbar 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.