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Newbury Blue Pain Balm

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This product has been discontinued

Active ingredients
  • Camphor (synthetic) 3 g/100 mL
  • Menthol 10 g/100 mL
  • Methyl Salicylate 25 g/100 mL
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 2024
Label revision date
September 30, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 3 g/100 mL
  • Menthol 10 g/100 mL
  • Methyl Salicylate 25 g/100 mL
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 2024
Label revision date
September 30, 2024
Manufacturer
Newbury Extracts, LLC
Registration number
M017
NDC root
83501-101
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

If you're experiencing discomfort from aches, arthritis, muscle spasms, or general neck and back pain, there are medications designed to help relieve these symptoms. These drugs work by targeting the underlying causes of pain, providing you with the comfort you need to go about your daily activities.

It's important to consult with a healthcare professional to find the right option for your specific needs and to ensure safe and effective use.

Uses

You can use this medication to help relieve various types of pain, including aches, arthritis, muscle spasms, and general neck and back pain. It’s designed to provide comfort and improve your mobility when dealing with these discomforts.

Rest assured, there are no known harmful effects on pregnancy (teratogenic effects) or any other non-pregnancy related issues associated with this medication.

Dosage and Administration

To use the balm effectively, start by applying it generously to the area that needs treatment. Gently massage the balm into your skin until it is fully absorbed. This helps ensure that the medication works properly. After you’re done applying the balm, make sure to wash your hands thoroughly with soap and water to avoid any accidental contact with your eyes.

If you are under 18 years old, it’s important to talk to a doctor before using this balm. Always remember to keep the balm away from your eyes to prevent irritation. Following these steps will help you use the balm safely and effectively.

What to Avoid

It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison control center immediately.

You should stop using this product and consult a doctor if you experience an allergic reaction, or if you notice any redness, irritation, swelling, pain, or other concerning symptoms. Additionally, if your condition worsens or does not improve within 7 days, please reach out to a healthcare professional for guidance.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid contact with your eyes, ears, and mouth. If you accidentally get it in your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if you experience any allergic reactions, or if you notice redness, irritation, swelling, pain, or other concerning symptoms. Additionally, if your condition worsens or does not improve within 7 days, seek medical advice.

Warnings and Precautions

This product is for external use only, so be sure to keep it away from your eyes, ears, and mouth. If it accidentally gets into your eyes, rinse them thoroughly with water. Always store this product out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

You should stop using this product and call your doctor if you experience any allergic reactions, or if you notice redness, irritation, swelling, pain, or other concerning symptoms. Additionally, if your condition worsens or does not improve within 7 days, it’s important to reach out to your healthcare provider for further guidance.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local poison control center or going to the nearest emergency room is crucial. They can provide the necessary guidance and treatment. Always remember that it's better to be safe and get checked if you have any doubts about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

If you are considering this medication for your child, it's important to know that children under 18 years of age should consult a physician (doctor) before use. This ensures that the treatment is safe and appropriate for their specific needs. Always prioritize your child's health by seeking professional advice before starting any new medication.

Geriatric Use

If you are caring for an older adult, it's important to be aware that children under 18 years old should consult a physician before using this medication. This precaution helps ensure safety and appropriate care for younger patients. Always consider discussing any concerns or questions with a healthcare provider to ensure the best outcomes for those you care for.

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 change based on renal impairment. However, it’s always best to consult with your healthcare provider about your kidney health and any medications you are taking. They can provide personalized advice and ensure that your treatment is safe and effective for you.

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. Since there are no details available regarding how liver impairment might affect the use of this medication, it’s crucial to consult your healthcare provider. They can offer personalized advice and ensure that your treatment is safe and effective based on your liver health. Always keep your doctor informed about any liver issues you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15-30°C (59-86°F). It's important to avoid freezing the product or exposing it to excessive heat, which means keeping it below 40°C (104°F).

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should know that this medication is applied topically, meaning it is used on the skin. If you are considering using this product for a child under 18 years old, it's important to consult a physician (a medical doctor) first to ensure it's safe and appropriate for them.

FAQ

What is this drug used for?

This drug is used for relief from aches, arthritis, muscle spasms, and overall neck and back pain.

How should I apply the balm?

You should apply the balm liberally and gently massage it into the affected area until absorbed into the skin.

What should I do after applying the balm?

After application, wash your hands with water and soap to avoid any unwanted contact.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Keep it out of your eyes, ears, and mouth, and rinse thoroughly with water if contact occurs.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, or if you notice redness, irritation, swelling, or pain, stop use and ask a doctor.

Can children use this product?

Children under 18 years of age should consult a physician before use.

What should I do if the condition worsens or does not improve?

If your condition worsens or does not improve within 7 days, stop use and consult a doctor.

How should I store this product?

Store the product between 15-30°C (59-86°F) and avoid freezing or excessive heat above 40°C (104°F).

Packaging Info

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

Packaging configurations for Newbury Blue Pain Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the relief of aches, arthritis, muscle spasms, and overall neck and back pain.

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

Dosage and Administration

The balm should be applied liberally to the affected area, followed by gentle massage until fully absorbed into the skin. It is essential to wash hands thoroughly with soap and water after application to prevent accidental contact with sensitive areas, particularly the eyes.

Healthcare professionals are advised to inform patients that children under 18 years of age should consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a poison control center is required.

  • Discontinue use and consult a healthcare professional if an allergic reaction occurs, or if redness, irritation, swelling, pain, or other symptoms develop.

  • If the condition worsens or does not improve within 7 days, seek medical advice.

Warnings and Precautions

FOR EXTERNAL USE ONLY. It is imperative to avoid contact with the eyes, ears, and mouth when using this product. In the event of accidental contact with the eyes, it is essential to rinse the eyes thoroughly with water to mitigate potential irritation.

General precautions must be observed to ensure safe use. This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a poison control center is advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: an allergic reaction, signs of redness, irritation, swelling, pain, or any other concerning symptoms. Additionally, if the condition being treated worsens or does not show improvement within 7 days, it is crucial to consult a healthcare provider for further evaluation and management.

Side Effects

Patients using this product should be aware that it is for external use only. Care should be taken to avoid contact with the eyes, ears, and mouth. In the event of contact with the eyes, patients are advised to rinse thoroughly with water.

Participants should discontinue use and consult a healthcare professional if any of the following occur: an allergic reaction, or if symptoms such as redness, irritation, swelling, or pain develop. Additionally, if the condition worsens or does not improve within 7 days, it is recommended that patients seek medical advice.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Newbury Blue Pain Balm.
Details

Pediatric Use

Pediatric patients under 18 years of age should consult a physician before use. It is essential for healthcare professionals to evaluate the appropriateness of treatment in this population, considering individual patient needs and potential risks.

Geriatric Use

Elderly patients may require special consideration when using this medication. It is important to note that children under 18 years of age should consult a physician prior to use; however, specific data regarding the safety and efficacy of this medication in geriatric patients is not provided.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Monitoring for potential adverse effects and therapeutic efficacy is recommended, and dose adjustments may be necessary based on individual patient factors.

Further clinical findings specific to geriatric patients should be reviewed to ensure safe and effective use in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

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

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding 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.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be informed to stop using the medication and consult a doctor if they experience any allergic reactions, including symptoms such as redness, irritation, swelling, or pain. Additionally, they should be advised to seek medical attention if their condition worsens or does not improve within 7 days of use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15-30°C (59-86°F). Care should be taken to avoid freezing the product, as well as exposure to excessive heat above 40°C (104°F). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the product is topical. Clinicians should advise that children under 18 years of age consult a physician prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Newbury Blue Pain 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 Newbury Blue Pain 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.