ADD CONDITION

items per page

Willow Balm

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 0.03 g/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 15, 2018
Active ingredient
Menthol 0.03 g/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 15, 2018
Manufacturer
I Woke Up Well Distributing Inc
Registration number
part356
NDC root
71629-035

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 product is designed to provide temporary relief from minor aches and muscle pains that you may experience due to conditions like arthritis, simple backache, strains, or muscle soreness and stiffness. It aims to help you feel more comfortable and improve your mobility during everyday activities.

Manufactured in the USA, this product is a convenient option for those seeking relief from common muscle and joint discomfort. If you have any questions or need more information, you can reach out to the manufacturer or visit their website.

Uses

If you're dealing with minor aches and muscle pains, this medication can help provide temporary relief. It's effective for discomfort related to arthritis, simple backaches, strains, and muscle soreness or stiffness. Whether you're recovering from a workout or managing chronic pain, this option may ease your symptoms and help you feel more comfortable.

Dosage and Administration

To use this product, simply apply it directly to the area that is affected. You can use it as needed, but make sure not to apply it more than four times in a single day. This will help ensure you get the best results while minimizing any potential side effects.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding 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 use this medication only as directed and for external use only. Avoid getting it in your eyes or on mucous membranes, and do not cover the area with a bandage. Additionally, refrain from using it on open wounds or damaged skin. Keep the product out of reach of children, and if you are considering it for a child under 12, please consult a physician first.

Warnings and Precautions

It's important to use this medication only as directed and for external use only. Avoid getting it in your eyes or on mucous membranes, and do not cover the area with a bandage. Make sure to keep it away from children, and if you have a child under 12, consult your doctor before use.

If you experience any unusual reactions or if the product comes into contact with open wounds or damaged skin, stop using it immediately and call your doctor. Always prioritize safety and follow these guidelines to ensure effective and safe use.

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 feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. They can provide the necessary assistance and guidance. Always remember that it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product should be avoided during pregnancy, nor does it provide any dosage changes or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication or product to ensure it’s safe for you and your baby.

Lactation Use

When it comes to breastfeeding, there is currently no specific information available regarding the use of this medication for nursing mothers or its effects during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or considerations related to your specific situation. Always prioritize your health and the well-being of your baby when making decisions about medication use while nursing.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you have a child under the age of 12, be sure to consult your physician (doctor) before giving them this medication. They can provide guidance on whether it's safe and appropriate for your child's specific needs.

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 for personalized advice. 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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition effectively while considering any medications you may need.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when you're not using it to maintain its integrity. If you open the tube and do not use the contents within a specified time, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply the product directly to the affected area as needed, but remember not to use it more than four times a day. This topical medication is designed for direct application to help manage your condition effectively. If you have any questions about how to use it, consult your healthcare provider for guidance.

FAQ

What is the primary use of this product?

This product is used for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness, and stiffness.

How should I apply the product?

You should apply the product directly to the affected area. It may be used as necessary, but do not use it more than four times daily.

Are there any warnings I should be aware of?

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

What should I do if I have children under 12?

Consult a physician before using this product on children under 12.

How should I store this product?

Store the product at room temperature, protect it from light, and keep the tube tightly closed when not in use.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing mothers.

What should I do if I accidentally get the product in my eyes?

Avoid contact with eyes and mucous membranes. If contact occurs, rinse thoroughly with water and seek medical attention if necessary.

Is there any information on drug interactions?

No drug interactions have been mentioned in the provided information.

Packaging Info

Below are the non-prescription pack sizes of Willow Balm (topical pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Willow Balm.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness, and stiffness. It is intended for use in patients experiencing these conditions to alleviate discomfort and improve mobility.

Dosage and Administration

The product should be applied directly to the affected area. It may be used as necessary, with a maximum frequency of four applications per day. Healthcare professionals are advised to monitor the patient's response to treatment and adjust the frequency of application as needed, ensuring that the total number of applications does not exceed the recommended limit.

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

External use only; this product must be utilized strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes. The application should not be covered with a bandage, and it is contraindicated for use on open wounds or damaged skin.

Healthcare professionals should ensure that this product is stored out of reach of children to prevent accidental ingestion or misuse. For pediatric patients under the age of 12, consultation with a physician is strongly advised prior to use.

Side Effects

Patients should be aware that the product is intended for external use only and must be used strictly as directed. It is crucial to avoid contact with the eyes and mucous membranes. The product should not be covered with a bandage, nor should it be applied to open wounds or damaged skin. Additionally, it is important to keep the product out of reach of children. For children under the age of 12, consultation with a physician is recommended prior to use.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Willow Balm (topical pain reliever). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Willow Balm.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For children under the age of 12, it is advised to consult a physician prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

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. The effects on breastfed infants have not been established, and further research may be necessary to determine any implications for breastfeeding.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, no dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function are specified in the prescribing information. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be instructed to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, any unused product should be discarded after opening, adhering to the specified time frame for safety and efficacy, although this time frame is not detailed in the provided information.

Additional Clinical Information

The product is administered topically, with application directly to the affected area. It may be used as necessary, but should not exceed four applications per day. 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 Willow 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 Willow 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.