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Herbal Balm

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Active ingredients
  • Camphor (synthetic) 31 mg/1 g
  • Menthol 156 mg/1 g
  • Methyl Salicylate 207 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
November 20, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Camphor (synthetic) 31 mg/1 g
  • Menthol 156 mg/1 g
  • Methyl Salicylate 207 mg/1 g
Other brand names
Dosage form
Cream
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 2022
Label revision date
November 20, 2023
Manufacturer
Big 5 Nutrition LLC
Registration number
M017
NDC root
82198-0007
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

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as arthritis, strains, bruises, sprains, and simple backaches. If you're experiencing discomfort from any of these issues, this drug may be a suitable option to help ease your pain.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for discomfort caused by conditions such as arthritis, strains, bruises, sprains, and simple backaches.

This means that if you're dealing with any of these issues, this medication may help ease your pain and improve your comfort. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

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 twice a 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

You should avoid using this product in several situations to ensure your safety. Do not apply it to wounds, irritated or damaged skin, or sensitive areas. It's also important not to use it with a heating pad, 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. Always follow the directions provided and do not use it in any way other than as directed.

Side Effects

When using this product, it's important to be aware of certain precautions and potential side effects. You should only apply it externally and avoid using it on wounds, irritated or damaged skin, or sensitive areas. Additionally, do not use it with heating pads, if you are pregnant, or alongside other external pain relief products. If you experience worsening symptoms, persistent issues for more than seven days, excessive skin irritation, or any redness, stop using the product and consult a doctor.

If you are pregnant, it's advisable to consult a healthcare professional before use. Always keep the product out of reach of children to prevent accidental poisoning, and in case of an overdose, seek medical help immediately. Remember to avoid contact with your eyes and do not apply the product tightly or right before or after bathing.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds, irritated or damaged skin, or sensitive areas. If you are pregnant, using a heating pad, or taking other external pain relief products, do not use this product. Additionally, steer clear of it if you have allergies to aspirin, salicylates, or any of the ingredients in this product.

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 consult your doctor. You should also seek medical advice if you experience excessive skin irritation, redness, or any side effects. In the event of an overdose, it’s crucial to get medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. Always use medications exactly as directed to avoid the risk of overdose.

Remember, acting quickly can make a significant difference in your health. If you or someone else may have taken too much of a medication, don’t hesitate to reach out for professional assistance. Your safety is the top priority.

Pregnancy Use

If you are pregnant, it is important to avoid using this medication. Always consult with a healthcare professional before considering any medication during pregnancy. 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, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

It's important to be cautious when considering medication for your child. If your child is under 2 years old, you should not use this medication without consulting a doctor first. This is to ensure their safety and well-being.

Additionally, always keep medications out of reach of children to prevent accidental poisoning. Taking these precautions can help protect your little ones and ensure they stay safe.

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, it’s important to consult with a healthcare provider before starting the medication. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have 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 help monitor your kidney function and make any necessary adjustments to your treatment plan.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using this medication. You should not use it alongside other external pain relief products, as this can increase the risk of side effects. Additionally, if you have allergies to aspirin, salicylates, or any ingredients in this product, you should avoid using it altogether.

Always discuss any medications you are taking with your healthcare provider to ensure they are safe to use together. This helps prevent any potential interactions and ensures your treatment is effective and safe.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20 to 25°C (68 to 77°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using it twice a day for best results. If you are pregnant, it's important to consult a healthcare professional before using this product. Always keep it out of reach of children to prevent accidental poisoning. In the event of an overdose, seek medical assistance or contact a Poison Control Center immediately.

FAQ

What is the drug used for?

This drug is used for temporary relief of minor aches and pains of muscles and joints due to conditions like arthritis, strains, bruises, sprains, and simple backache.

How should I apply the drug?

You should apply it to the affected area and rub it well. It is recommended to repeat this process two times daily.

Are there any contraindications for using this drug?

Yes, do not use it on wounds, irritated or damaged skin, sensitive skin, or with a heating pad. Additionally, do not use if you are pregnant or allergic to aspirin or salicylates.

What should I do if I experience side effects?

If your condition worsens, symptoms persist for more than 7 days, or if excessive irritation or redness occurs, stop use and consult a doctor.

Can I use this drug if I am pregnant?

No, you should not use this drug if you are pregnant. If you are pregnant, consult a health professional before use.

What precautions should I take while using this product?

Avoid contact with eyes, do not bandage tightly, and do not apply to wounds or damaged skin. Also, do not use 1 hour before or after bathing.

What should I do in case of overdose?

In case of overdose, seek medical help or contact a Poison Control Center immediately.

How should I store this drug?

Store the drug at room temperature, between 20 to 25°C (68 to 77°F).

Is this drug safe for children?

Children under 2 years of age should not use this drug without consulting a doctor.

Packaging Info

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

Packaging configurations for Herbal Balm.
Details

Drug Information (PDF)

This file contains official product information for Herbal 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 text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints due to various conditions, including arthritis, strains, bruises, sprains, and simple backache.

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 twice daily for optimal results.

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

The product is contraindicated in the following situations:

Use is prohibited on wounds, irritated or damaged skin, and sensitive skin due to the potential for exacerbating these conditions. Application with a heating pad is contraindicated as it may increase the risk of adverse effects. The product should not be used during pregnancy due to potential risks to the fetus. Concurrent use with other external analgesic products is not recommended, as it may lead to increased side effects. Individuals with known allergies to aspirin, salicylates, or any ingredients in this product should avoid use to prevent allergic reactions. Additionally, the product should not be used otherwise than as directed.

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. Pregnant individuals should avoid using this product. It is also contraindicated for individuals who are allergic to aspirin, salicylates, or any other ingredients contained in this formulation. Furthermore, the product should not be used simultaneously with other external analgesic products.

Healthcare professionals should advise patients to discontinue use and seek medical advice 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, redness appears, or any side effects manifest.

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which should be carefully monitored. The product is intended for external use only and should not be applied to wounds, irritated or damaged skin, or sensitive skin. Additionally, it should not be used in conjunction with heating pads, during pregnancy, or with other external analgesic products. Patients with known allergies to aspirin, salicylates, or any ingredients in this product should avoid its use.

While using this product, patients are advised to avoid contact with the eyes, refrain from tightly bandaging the area, and not apply it to wounds or damaged skin. It is also recommended that the product not be used within one hour before or after bathing.

Patients should discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, persistence of symptoms beyond seven days, recurrence of symptoms after initial improvement, excessive skin irritation, or the presence of redness.

In addition, if a patient is pregnant, it is advisable to seek guidance from a healthcare professional prior to use. The product should be kept out of reach of children to prevent accidental poisoning. In the event of an overdose, immediate medical assistance should be sought or a Poison Control Center contacted. It is crucial that the product is used strictly as directed to minimize the risk of adverse reactions.

Drug Interactions

The use of this product is contraindicated in conjunction with other external analgesic products due to the potential for additive effects, which may increase the risk of adverse reactions. Additionally, individuals with a known allergy to aspirin or salicylates should avoid using this product, as well as those who are allergic to any of its ingredients.

There are no specific laboratory test interactions associated with this product. Therefore, routine monitoring of laboratory tests is not required when using this medication.

Packaging & NDC

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

Packaging configurations for Herbal Balm.
Details

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.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for 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 caution is advised to avoid any adverse fetal outcomes. 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 is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with excessive intake.

Healthcare professionals are advised to ensure that patients understand the importance of adhering strictly to prescribed dosages. The medication should not be used in any manner other than as directed to prevent the risk of overdose and its associated complications.

Monitoring for symptoms of overdose is essential, although specific symptoms are not detailed in the provided information. Therefore, healthcare providers should remain vigilant and prepared to manage any adverse reactions that may arise from an overdose situation.

Nonclinical Toxicology

If pregnant, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are provided 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 adhering to the prescribed usage and to avoid using the medication in any manner other than as directed.

In the event of an overdose, patients should be instructed to seek medical assistance immediately or contact a Poison Control Center for guidance. This information is vital for ensuring patient safety and effective management of potential overdose situations.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20 to 25°C (68 to 77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The product is administered topically, with a recommended frequency of twice daily. Clinicians should counsel patients to consult a health professional if they are pregnant before using the product. It is also important to advise patients to keep the product out of reach of children to prevent accidental poisoning. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Herbal 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 Herbal 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.