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Neck and Lumbar Pain Relieving Balm

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Active ingredients
  • Camphor (synthetic) 11 g/100 g
  • Menthol 16 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Ointment
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) 11 g/100 g
  • Menthol 16 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Ointment
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
55614-661
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 AND LUMBAR PAIN RELIEVING BALM is an external analgesic designed to provide temporary relief from minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backache, arthritis, strains, bruises, and sprains.

This balm contains key ingredients like camphor, menthol, and methyl salicylate, which work together to soothe discomfort and promote a sense of relief. If you're experiencing muscle or joint pain, this product may be a supportive option to consider for alleviating your symptoms.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains.

You can rely on this treatment to ease discomfort and help you get back to your daily activities. Remember, it's designed for short-term use to alleviate those nagging pains.

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. They will provide guidance on the appropriate treatment for younger children. Always follow your healthcare provider's instructions to ensure safe and effective use.

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 or hot water bottles 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 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 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 irritated or damaged skin and do not use it on open wounds. To ensure safety, keep it out of reach of children to prevent accidental poisoning. If swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Additionally, seek medical advice if you experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash. If you feel 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, or if redness is present, please consult your doctor. This is especially important for children under 12 years of age.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look out for unusual symptoms such as extreme drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to err on the side of caution and get help.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious when using this product. Avoid applying it to irritated or damaged skin, as well as on any wounds. Always consult with your doctor or pharmacist if you have any concerns about using this product during your pregnancy.

While using this product, follow the directions carefully and do not use it in any other way. If your condition worsens, symptoms last longer than 7 days, or if you experience any unusual reactions such as nausea, vomiting, abdominal discomfort, diarrhea, skin rash, or if you feel pain or notice blistering or burning after application, stop using it and seek medical advice. Additionally, if you have children under 3 years of age, please consult your physician before use.

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 is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while 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 experiencing arthritis pain and they are under 12 years old, monitor their symptoms closely. If the pain lasts more than 10 days, if you notice any redness, or if symptoms improve and then return within a few days, stop using the medication and consult a doctor.

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 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 for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

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

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 your overall treatment plan is safe and effective.

Always discuss any other medications, supplements, or health conditions you have, as this information is crucial for your safety and well-being. Your provider can guide you on how to manage your health effectively.

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 helps protect the product from light and maintains 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 from your product.

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 a day. If the patient is under 3 years old, it's important to consult a physician before use.

Be sure to report any unexpected side effects to the FDA MedWatch Program. Keep the 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 AND 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 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.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes or mucous membranes, and do not use on irritated or damaged skin or on wounds.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience excessive skin irritation or other serious side effects.

Is it safe to use during pregnancy or while nursing?

No teratogenic effects are mentioned, and there are no specific warnings for nursing mothers, but consult your physician if you have concerns.

How should I store the balm?

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

What should I do if the balm is swallowed?

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

Packaging Info

Below are the non-prescription pack sizes of Neck and Lumbar Pain Relieving Balm (camphor, menthol, 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

No description information is available.

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. 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 keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

Patients are instructed to discontinue use and consult a healthcare provider 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 a warming or cooling sensation is expected.

When using this product for arthritis-related pain, patients should seek medical advice if pain persists for more than 10 days, if redness is observed, or if the product is being used in children under 12 years of age.

Side Effects

Patients using this product should be aware that it is intended for external use only. In clinical practice, participants are advised to discontinue use and consult a healthcare professional 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, 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, actual pain, blistering, or burning sensations warrant immediate cessation of use and consultation with a healthcare provider.

For those 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 observed, 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 are no known 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 Neck and Lumbar Pain Relieving Balm (camphor, menthol, 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 of age, if pain persists for more than 10 days, if redness is present, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a doctor should be consulted.

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, given the lack of targeted data.

Pregnancy

Pregnant patients should exercise caution when considering the use of this product. It is advised that they consult with a healthcare professional, such as a doctor or pharmacist, prior to use, especially if there are any concerns regarding its application. The product should not be applied to irritated or damaged skin, nor should it be used on wounds.

While specific risk categories for pregnancy are not provided, it is important for pregnant patients to adhere strictly to the directions for use. If any adverse reactions occur, such as excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or skin rash, the patient should discontinue use and seek medical advice. Additionally, if symptoms worsen, persist for more than 7 days, or recur shortly after resolution, medical consultation is recommended.

For children under 3 years of age, it is essential to consult a physician before use. Overall, pregnant patients should prioritize safety and seek guidance from healthcare professionals when considering the use of this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about 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 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 of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

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 directly by calling 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 help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on irritated or damaged skin, or on open wounds. It is important to inform 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 excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

Patients should also be cautioned to stop use and consult a doctor if they feel actual pain or experience blistering or burning after application, noting that a warming or cooling sensation is normal. If pain persists for more than 10 days while using the product for arthritis pain, or if redness is present, patients should seek medical advice. Special attention should be given to patients with conditions affecting children under 12 years of age, as they should consult a doctor before use.

When using this product, patients must be reminded to follow the directions carefully and avoid contact with the eyes or mucous membranes. They should not bandage the area tightly or apply heat in the form of heating pads, hot water bottles, or lamps, as this increases the risk of serious burns. Patients are encouraged to ask 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 in a location that is protected from light, within a temperature range of 15 to 30°C (59 to 86°F). Proper adherence to these storage conditions is essential for ensuring 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, consultation with a physician is advised.

Clinicians should counsel patients 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, immediate 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.

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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.