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Bt Pain Relief Balm
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- Active ingredients
- Camphor, (-) - 31.1 mg/1 g
- Menthol, Unspecified Form 155.5 mg/1 g
- Methyl Salicylate 207.3 mg/1 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 2024
- Label revision date
- November 21, 2023
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Camphor, (-) - 31.1 mg/1 g
- Menthol, Unspecified Form 155.5 mg/1 g
- Methyl Salicylate 207.3 mg/1 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 2024
- Label revision date
- November 21, 2023
- Manufacturer
- Big 5 Nutrition LLC
- Registration number
- M017
- NDC root
- 82198-0010
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
This medication is designed to provide temporary relief from minor aches and pains in your muscles. It can be helpful for various conditions, including strains, bruises, sprains, simple backaches, and even discomfort from travel and motion sickness. Additionally, it may alleviate itching caused by insect and mosquito bites, as well as symptoms related to heat stroke and dizziness.
Uses
You can use this medication for the temporary relief of minor aches and pains in your muscles caused by various conditions. This includes discomfort from strains, bruises, sprains, and simple backaches. It can also help alleviate symptoms related to travel and motion sickness, as well as itching from insect and mosquito bites. Additionally, it may provide relief if you're experiencing heat stroke or dizziness.
Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.
Dosage and Administration
To use this medication, start by applying it directly to the area that is affected. Make sure to rub it in well so that it can work effectively. You should repeat this application a few times throughout the day for the best results.
If you are considering this medication for a child under 2 years of age, it’s important not to use it without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.
What to Avoid
It's important to use this medication only as directed by your healthcare provider. Avoid using it in any way that is not specified in the instructions. While there are no specific contraindications or concerns about abuse, misuse, or dependence mentioned, following the prescribed guidelines is essential for your safety and well-being. Always consult your doctor if you have any questions or concerns about your treatment.
Side Effects
When using this product, it's important to be aware of certain precautions and potential side effects. This product is for external use only and should not be applied to wounds, irritated or damaged skin, or sensitive areas. Avoid using it with heating pads, during pregnancy, or alongside other external pain relief products. If you have allergies to aspirin, salicylates, or any ingredients in this product, you should not use it.
While using the product, take care to avoid contact with your eyes and do not apply it tightly or on damaged skin. If your condition worsens, symptoms last longer than seven days, or if you experience excessive skin irritation or redness, stop using the product and consult a doctor.
Warnings and Precautions
This product is for external use only, so please avoid applying it to wounds, irritated or damaged skin, or sensitive areas. Do not use it with a heating pad, if you are pregnant, or if you are allergic to aspirin, salicylates, or any ingredients in this product. While using it, be careful to avoid contact with your eyes, do not bandage the area tightly, and refrain from using it one hour before or after bathing.
If your condition worsens, symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and call your doctor. Additionally, seek medical attention if you experience excessive skin irritation, redness, or any side effects.
In case of an overdose, it’s important to get emergency medical help or contact a Poison Control Center immediately.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.
Pregnancy Use
If you are pregnant, it is important to avoid using this medication. Using it during pregnancy could pose risks to you and your developing baby. If you are pregnant or planning to become pregnant, please consult with a healthcare professional before considering this medication. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby.
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. This means that, based on current information, it is considered safe for you to use it without concerns about affecting your milk production or your baby. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.
Pediatric Use
If you have a child under 2 years old, it's important not to use this medication without consulting a doctor first. For the safety of your little ones, always keep this medication out of their reach to prevent accidental poisoning. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance. Your child's safety is a top priority, so please take these precautions seriously.
Geriatric Use
While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.
Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best approach for your treatment.
Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.
Drug Interactions
It's important to be cautious when using certain medications together. You should avoid using this product alongside other external pain relief products, as combining them can lead to unwanted effects. Always discuss any medications you are taking with your healthcare provider to ensure your safety and the effectiveness of your treatment.
Additionally, there are no specific laboratory test interactions noted, but it's still a good practice to inform your healthcare provider about all the medications you are using. This way, they can provide the best care tailored to your needs.
Storage and Handling
To ensure the best performance and safety of your product, store any unused items in their original box. It's important to keep them at room temperature, specifically between 20 to 25 °C (68 to 77 °F). This temperature range helps maintain the product's integrity and effectiveness.
When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these simple storage and handling guidelines will help you use the product safely and effectively.
Additional Information
You should apply the medication topically to the affected area, rubbing it in well. For best results, repeat this process a few times daily. There are no additional details regarding laboratory tests, abuse potential, or patient counseling information available at this time.
FAQ
What is the drug indicated for?
The drug is indicated for the temporary relief of minor aches and pains of muscles due to conditions like strains, bruises, sprains, simple backache, travel and motion sickness, itching from insect bites, and heat stroke.
How should I use this drug?
Apply the drug to the affected area and rub it well. You can repeat this a few times daily.
Are there any warnings for using this drug?
Yes, it is for external use only. Do not use it on wounds, irritated skin, or if you are pregnant. Avoid contact with eyes and do not bandage tightly.
What should I do if my condition worsens?
Stop using the product and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if excessive skin irritation occurs.
Can children use this drug?
Children under 2 years of age should not use this drug without consulting a doctor.
Is there any information about using this drug during pregnancy?
Do not use this drug if you are pregnant. If pregnant, consult a health professional before use.
How should I store this drug?
Store the drug in its box at room temperature, between 20 to 25 °C (68 to 77 °F).
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center immediately.
Packaging Info
Below are the non-prescription pack sizes of Bt Pain Relief Balm (methyl salicylate, menthol, camphor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Drug Information (PDF)
This file contains official product information for Bt Pain Relief Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is identified by the SPL code 34089-3. No specific description details are provided in the text.
Uses and Indications
This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including strains, bruises, sprains, simple backache, travel and motion sickness, itching from insect and mosquito bites, as well as heat stroke and dizziness.
There are no teratogenic or nonteratogenic effects associated with this drug.
Dosage and Administration
The medication should be applied to the affected area and rubbed in thoroughly. It is recommended to repeat this application a few times daily, as needed, to achieve the desired effect.
For pediatric patients, the use of this medication is contraindicated in children under 2 years of age. In such cases, consultation with a healthcare professional is advised prior to use.
Contraindications
There are no specified contraindications for this product. However, it is essential to adhere strictly to the recommended usage guidelines. Use of this product otherwise than as directed is not advised.
Warnings and Precautions
For external use only. This product is contraindicated in several situations. It should not be applied to wounds, irritated or damaged skin, or sensitive skin. Additionally, it must not be used in conjunction with a heating pad, during pregnancy, or with other external analgesic products. Individuals with known allergies to aspirin, salicylates, or any ingredients contained in this product should avoid its use.
When utilizing this product, it is imperative to avoid contact with the eyes. Bandaging should not be done tightly, and application to wounds or damaged skin is strictly prohibited. Furthermore, it is advised not to use the product within one hour before or after bathing to ensure safety and efficacy.
Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than seven days, symptoms resolve and then recur within a few days, excessive skin irritation develops, redness is observed, or any side effects manifest.
In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
Side Effects
Patients using this product should be aware that it is intended for external use only. It is contraindicated in individuals with known allergies to aspirin, salicylates, or any ingredients contained in the formulation. Additionally, the product should not be applied to wounds, irritated or damaged skin, or sensitive skin. It is also advised not to use the product in conjunction with a heating pad or other external analgesic products, and it is not recommended for use during pregnancy.
While using this product, patients should take precautions to avoid contact with the eyes and should not bandage the area tightly. Application should be avoided one hour before or after bathing to ensure safety and efficacy.
Patients 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, excessive skin irritation, presence of redness, or any side effects.
Drug Interactions
The concurrent use of this product with other external analgesic products is contraindicated. Co-administration may lead to an increased risk of adverse effects due to overlapping pharmacological actions. It is advised to avoid using these products simultaneously to ensure patient safety and efficacy of treatment.
No specific interactions with laboratory tests have been identified. Therefore, routine laboratory monitoring is not required when using this product.
Packaging & NDC
Below are the non-prescription pack sizes of Bt Pain Relief Balm (methyl salicylate, menthol, camphor). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Ointment |
| ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric patients under 2 years of age should not use this medication without consulting a healthcare professional. It is essential to keep the medication out of reach of children to prevent accidental poisoning. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.
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.
Pregnancy
Pregnant patients should not use this medication. If a patient becomes pregnant while using this medication, it is essential to consult a healthcare professional for guidance. The potential risks associated with the use of this medication during pregnancy have not been established, and therefore, caution is advised. Women of childbearing potential should be informed of these risks and encouraged to discuss any plans for pregnancy with their healthcare provider prior to initiating treatment.
Lactation
There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no specific warnings or recommendations concerning the use of this product during lactation.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.
It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.
Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken promptly.
Nonclinical Toxicology
If pregnant, it is advised to consult a health professional before use. The product should not be used by individuals with known allergies to aspirin, salicylates, or any other ingredients contained within the formulation.
No relevant information is available regarding nonclinical toxicology or animal pharmacology and 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 poisoning. It is crucial to emphasize the importance of using the medication only as directed and to avoid any unauthorized use.
In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. This information is vital for ensuring patient safety and effective management of potential overdose situations.
Storage and Handling
Unused products should be stored in their original box to ensure protection and integrity. The recommended storage temperature is at room temperature, specifically between 20 to 25 °C (68 to 77 °F). It is essential to maintain these conditions to preserve the quality of the product.
Additional Clinical Information
The medication is administered topically, with application directed to the affected area. Patients are advised to rub the medication well into the affected area and to repeat this process a few times daily for optimal results.
No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.
Drug Information (PDF)
This file contains official product information for Bt Pain Relief Balm, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.