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Biofreeze

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Active ingredient
Menthol, Unspecified Form 40 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2012
Label revision date
November 13, 2023
Active ingredient
Menthol, Unspecified Form 40 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2012
Label revision date
November 13, 2023
Manufacturer
RB Health (US) LLC
Registration number
M017
NDC root
59316-102

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Drug Overview

BiOFREEZE is a menthol-based gel designed to provide temporary relief from minor aches and pains in muscles and joints. It can be particularly helpful for conditions such as simple backaches, arthritis, strains, bruises, and sprains. By applying this cooling gel to the affected area, you may experience soothing relief that can help you manage discomfort and improve your mobility.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backaches, arthritis, strains, bruises, and sprains. This means if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your comfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

When using this medication, you should apply a thin layer to the affected area. For adults and children aged 2 years and older, you can do this up to 3 to 4 times a day. If you have a child under 2 years of age, it’s important to consult a physician (doctor) before using the medication.

After applying the medication, make sure to wash your hands with cool water to avoid spreading it to other areas or surfaces. Following these steps will help ensure you use the medication safely and effectively.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid using it on irritated skin or if you notice excessive irritation developing. Be cautious not to bandage the area tightly, and refrain from using it in conjunction with heating pads or devices, as this can increase the risk of adverse effects. Following these guidelines will help ensure your safety while using this product.

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 be kept away from heat or open flames, as it is flammable. Avoid contact with your eyes and mucous membranes, and do not apply it to wounds, damaged skin, or irritated areas. If you notice any pain, swelling, or blistering of the skin, or if your condition worsens or does not improve after 7 days, you should stop using the product and consult a doctor. Additionally, if you have arthritic pain that lasts more than 10 days or if redness appears, seek medical advice.

If the product is accidentally swallowed, it's crucial to get medical help or contact a Poison Control Center immediately. Always use the product as directed to minimize the risk of adverse reactions.

Warnings and Precautions

This product is for external use only, so please avoid using it on broken skin or areas that are irritated. It is also flammable, so keep it away from heat sources and open flames. Always use the product as directed, and be careful not to get it in your eyes or on mucous membranes.

If you notice any pain, swelling, or blistering of the skin, or if your condition worsens or does not improve after 7 days, stop using the product and call your doctor. Additionally, if you have arthritic pain that lasts more than 10 days, or if redness appears, seek medical advice. This product is not recommended for children under 12 years of age.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to consult a physician before using this medication. For children aged 2 years and older, you can apply a thin layer to the affected area, but be sure to do this no more than 3 to 4 times a day.

If you notice any concerning conditions in children under 12 years of age, stop using the product and consult a doctor. Always prioritize your child's health and safety by following these guidelines.

Geriatric Use

When considering the use of BIOFREEZE menthol gel for older adults, it's important to note that the drug insert does not provide specific information about dosage adjustments, safety concerns, or special precautions for elderly patients. This means that while the product may be used, there are no tailored guidelines or recommendations specifically for older adults.

As always, if you or a caregiver are considering using this product, it's wise to consult with a healthcare professional. They can provide personalized advice based on individual health needs and any other medications you may be taking.

Renal Impairment

If you have kidney issues, 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 problems). This means that there are no tailored recommendations for how your kidney function 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 effective for your specific condition. They can help determine the best approach based on your kidney health.

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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, always do so with clean hands and in a sterile field (a clean area free from germs) to maintain safety and effectiveness. If you have any specific disposal instructions, be sure to follow them carefully to ensure proper safety.

Additional Information

You should apply this medication by rubbing a thin film over the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a physician before use.

If you are pregnant or breastfeeding, make sure to ask a health professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is BiOFREEZE?

BiOFREEZE is a menthol pain-relieving gel designed to temporarily relieve minor aches and pains of muscles and joints.

What conditions does BiOFREEZE help relieve?

It helps relieve minor aches and pains associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use BiOFREEZE?

Rub a thin film over the affected area not more than 3 to 4 times daily for adults and children 2 years of age and older. Consult a physician for children under 2 years.

Are there any warnings for using BiOFREEZE?

Yes, it is for external use only, flammable, and should be kept away from excessive heat or open flame.

What should I do if I experience side effects?

Stop use and ask a doctor if you experience pain, swelling, blistering of the skin, or if symptoms persist for more than 7 days.

Can I use BiOFREEZE if I am pregnant or breastfeeding?

You should ask a health professional before use if you are pregnant or breastfeeding.

What should I do if BiOFREEZE is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store BiOFREEZE?

Store BiOFREEZE at 20-25°C (68-77°F) in a cool, dry place away from direct sunlight.

Packaging Info

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

Packaging configurations for Biofreeze.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

BiOFREEZE® is a menthol-based pain-relieving gel formulated to provide temporary relief from muscle and joint pain. The product is presented in a gel dosage form, with a net volume of 16 fluid ounces (473 mL). It is clinically recommended for use in pain management. The National Drug Code (NDC) for this product is 59316-102-30.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, a thin film of the product should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, hands should be washed thoroughly with cool water to prevent accidental contact with other areas of the body or with other individuals.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for adverse reactions. Application to irritated skin or in cases where excessive irritation develops is also contraindicated, as this may exacerbate the condition. Additionally, the product should not be used with tight bandaging or in conjunction with heating pads or devices, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

General precautions should be observed when using this product. It is essential to use the product only as directed. Care should be taken to avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad or device, as this may exacerbate adverse effects.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms for more than 7 days; recurrence of symptoms after initial improvement within a few days; arthritic pain lasting more than 10 days; presence of redness; or if the product is being used on children under 12 years of age.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended to ensure prompt and appropriate care.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

During use, patients should avoid contact with the eyes and mucous membranes. It is advised not to apply the product to wounds, damaged skin, or irritated skin, especially if excessive irritation develops. Additionally, patients should refrain from tightly bandaging the area or using the product in conjunction with heating pads or devices.

Patients are instructed to discontinue use and consult a healthcare professional if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; recurrence of symptoms after clearing; arthritic pain lasting more than 10 days; or the presence of redness. Special caution is advised for conditions affecting children under 12 years of age.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Biofreeze (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Biofreeze.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily. It is advised to discontinue use and seek medical advice if any conditions affecting children under 12 years of age are present.

Geriatric Use

There is no specific information regarding the use of BIOFREEZE menthol gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted studies in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information 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 absence of data limits the ability to make informed decisions regarding its use in this population. Regular monitoring of renal function may be warranted in these patients, although specific recommendations are not provided.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 for the product associated with SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that they should monitor for any signs of pain, swelling, or blistering of the skin. If these symptoms occur, or if the condition worsens, patients should be instructed to seek medical attention. Additionally, patients should be made aware that if symptoms persist for more than 7 days, or if they clear up and then recur within a few days, they should consult their healthcare provider. For those experiencing arthritic pain, it is essential to inform them that they should seek medical advice if the pain persists for more than 10 days, or if redness is present, particularly in children under 12 years of age.

Patients must be reminded to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, as this could lead to irritation. Furthermore, patients should not apply the product to wounds or damaged skin, nor should they use it on irritated skin or if excessive irritation develops. It is also crucial to advise patients against tightly bandaging the area or using the product in conjunction with a heating pad or device, as this may exacerbate irritation or cause adverse effects.

Storage and Handling

The product is supplied in packaging that ensures its integrity during storage. It should be stored at a temperature range of 20-25°C (68-77°F) in a cool, dry place, away from direct sunlight. Proper storage conditions are essential to maintain the product's efficacy and safety.

Additional Clinical Information

Patients aged 2 years and older are advised to apply a thin film of the medication over the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact with a Poison Control Center should be made.

Drug Information (PDF)

This file contains official product information for Biofreeze, 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 Biofreeze, 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.

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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.