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Bt Pain Relief

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 mL
  • Methyl Salicylate 50 mg/1 mL
Other brand names
Dosage form
Spray
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
November 21, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 mL
  • Methyl Salicylate 50 mg/1 mL
Other brand names
Dosage form
Spray
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
November 21, 2023
Manufacturer
Big 5 Nutrition LLC
Registration number
M017
NDC root
82198-0012
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

You can use this medication for temporary relief of joint and muscle aches and pains. It is commonly used to help with conditions such as sprains and strains, inflammation, and mild bruises. This can provide you with comfort and support during recovery from these types of injuries.

Uses

If you're experiencing temporary joint and muscle aches or pains, this medication can help provide relief. It's effective for treating various conditions, including sprains and strains, inflammation, and mild bruises.

You can rely on this treatment to ease discomfort and support your recovery from these common injuries. Remember, it's designed for short-term use to help you feel better as you heal.

Dosage and Administration

Before using the treatment, make sure the area of your skin where you will apply it is clean and dry. Once you're ready, spray the treatment directly onto your skin. If you prefer, you can gently rub it in for better absorption.

You can use this treatment up to 10 times a day if you are an adult or a child over the age of 2. Just remember to follow these steps each time to ensure the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

It's important to be aware of potential side effects when using this medication. You should only use it externally and as directed. Avoid getting it in your eyes or on mucous membranes, and do not apply it to open wounds or areas of irritated or broken skin. If you notice any skin rash or irritation, or if your condition worsens, stop using the product immediately.

If you are pregnant or breastfeeding, consult your doctor before using this medication to ensure it is safe for you. Always prioritize your health and safety by following these guidelines closely.

Warnings and Precautions

This product is intended for external use only, so be sure to apply it as directed. It's important to avoid contact with your eyes or any mucous membranes, and do not use it on open wounds or areas of skin that are irritated or broken.

If you notice any skin rash or irritation while using the product, stop using it immediately and contact your doctor. Additionally, if you are pregnant or breastfeeding, consult your doctor before using this product to ensure it is safe for you.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding any medications you may consider while nursing.

Pediatric Use

This medication can be used for children over the age of 2, but it’s important to remember that it should not be given more than 10 times a day. Always ensure that the medication is kept out of reach of children to prevent accidental ingestion. As a parent or caregiver, it's crucial to follow these guidelines to ensure the safety and well-being of your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 at room temperature. This helps maintain its effectiveness. Before using, make sure to shake the container well to mix the contents thoroughly. After each use, remember to close the cap tightly to prevent contamination and preserve the product's quality. Following these simple steps will help you use the product safely and effectively.

Additional Information

You can use this medication topically, which means you apply it directly to the skin. It is safe for both adults and children over the age of 2, and you can use it up to 10 times a day if needed. If you have any questions about how to use it or its effects, be sure to consult with your healthcare provider.

FAQ

What is the drug used for?

The drug is used for temporary relief of joint and muscle aches and pains, including conditions like sprains, strains, inflammation, and mild bruises.

How should I apply the drug?

You should spray the treatment directly onto clean and dry skin and gently rub it in if desired.

How often can I use this drug?

You may use it up to 10 times per day in adults and children over the age of 2.

Are there any warnings I should be aware of?

Yes, it is for external use only, should be used as directed, and you should avoid contact with eyes or mucous membranes. Do not use on open wounds or irritated skin.

What should I do if I experience skin rash or irritation?

You should discontinue use if a skin rash or irritation develops or if your condition worsens.

Can I use this drug if I am pregnant or breastfeeding?

You should consult your doctor before use if you are pregnant or breastfeeding.

How should I store the drug?

Store the drug at room temperature, shake well before use, and close the cap tightly after use.

Is there any information on drug interactions?

No specific drug interactions are mentioned in the insert.

Is there any information on contraindications?

There are no contraindications listed for this drug.

What should I do if I accidentally use it on broken skin?

You should not use it on open wounds or broken skin, and if you do, discontinue use immediately.

Packaging Info

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

Packaging configurations for Bt Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is formulated as a spray, providing a convenient dosage form for administration. The effective date of the insert is November 21, 2023. An image of the product is available, labeled as "Spray.jpg".

Uses and Indications

This drug is indicated for the temporary relief of joint and muscle aches and pains. It is effective in treating conditions such as sprains and strains, inflammation, and mild bruises.

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

Dosage and Administration

The application area should be cleaned and dried prior to treatment. The product is to be sprayed directly onto the skin. If desired, the treated area may be gently rubbed in to enhance absorption.

For both adults and children over the age of 2, the treatment may be administered up to 10 times per day. It is important to adhere to this frequency to ensure optimal efficacy while minimizing the risk of potential adverse effects.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only, this product should be applied strictly as directed. It is imperative to avoid contact with the eyes or mucous membranes to prevent irritation or adverse reactions. The product must not be applied to open wounds or on irritated or broken skin, as this may exacerbate the condition or lead to further complications.

In the event that a skin rash or irritation develops, or if the condition worsens, the use of this product should be discontinued immediately. Healthcare professionals are advised to counsel patients on these precautions to ensure safe usage.

Additionally, it is recommended that individuals consult their healthcare provider prior to use if they are pregnant or breastfeeding, to assess any potential risks associated with the use of this product during these sensitive periods.

Side Effects

Patients should be aware that the product is for external use only and must be used strictly as directed. It is important to avoid contact with the eyes or mucous membranes, and the product should not be applied to open wounds or on irritated or broken skin.

In clinical practice, patients are advised to discontinue use if a skin rash or irritation develops, or if the condition worsens. Additionally, it is recommended that individuals consult their healthcare provider before using the product if they are pregnant or breastfeeding. These precautions are essential to ensure the safety and well-being of patients using this product.

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 Bt Pain Relief (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bt Pain Relief.
Details

Pediatric Use

Pediatric patients over the age of 2 may use the medication up to 10 times per day. It is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

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 and those who are breastfeeding should consult their healthcare provider prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare professionals are advised to consider the individual circumstances of each patient when making recommendations regarding the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult their doctor before using this medication while breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending this medication to lactating patients.

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 prescribing information.

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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy and stability. Prior to use, the product should be shaken well to ensure proper mixing of its components. After each use, it is important to close the cap tightly to prevent contamination and preserve the integrity of the product.

Additional Clinical Information

The product is administered topically and may be applied up to 10 times per day for both adults and children over the age of 2. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Bt Pain Relief, 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 Bt Pain Relief, 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.