Biofreeze

Description

Biofreeze® is a pain-relieving roll-on formulation designed to provide penetrating, long-lasting relief from various types of pain, including arthritis, sore muscles and joints, and back pain. The active ingredient, menthol, offers a soothing effect, enhancing the cryotherapy experience known as The Cold Method®. This product is available in a 3 fl oz (89 mL) dosage form, suitable for topical application.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply a thin film of the medication over the affected areas, not exceeding four applications per day. It is not necessary to massage the area after application. For children under 2 years of age, consultation with a physician is recommended prior to use.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. It should not be applied to irritated skin or if excessive irritation develops, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion and potential complications. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin.

When using this product, it is imperative to avoid contact with the eyes or mucous membranes. The application should not be made to wounds or damaged skin, and it is contraindicated to use this product in conjunction with other ointments, creams, sprays, or liniments. Patients should refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, bandaging the area after application is not recommended. It is advised that patients wash their hands with cool water after use and avoid using the product with heating pads or devices.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

This product should be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin should consult a doctor.

During application, it is important to avoid contact with the eyes or mucous membranes and to refrain from applying the product to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and hands should be washed with cool water following use. Additionally, the product should not be used with heating pads or devices.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using this product.

This product should be kept out of the reach of children. In the event of accidental ingestion, medical help should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of multiple topical agents may lead to altered absorption and increased risk of adverse effects.

Additionally, the application of this medication in conjunction with heating pads or devices is not recommended. The use of heat may enhance the absorption of the medication, potentially leading to increased systemic exposure and heightened risk of side effects.

It is advised to monitor for any signs of adverse reactions when using this medication, particularly in the context of its application with other topical agents or heat sources.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under 2 years of age, it is recommended to consult a physician prior to use.

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 and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance 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 overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Symptoms of overdosage may vary depending on the specific medication involved; however, it is crucial to monitor the patient closely for any adverse reactions. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition and implement appropriate measures based on the severity of symptoms and the specific circumstances of the overdosage.

In all cases, the involvement of medical professionals is essential to ensure the safety and well-being of the patient.

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.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is accidentally ingested. It is important to inform patients that they should monitor their condition closely; if symptoms worsen, persist for more than 7 days, or if symptoms clear up and then recur, they should consult their healthcare provider.

Healthcare providers should emphasize the importance of avoiding contact with the eyes or mucous membranes, as well as instructing patients not to apply the product to wounds or damaged skin. Patients should be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, and they should not apply it to irritated skin or if excessive irritation develops.

Additionally, patients should be informed that the product should not be bandaged and that they should wash their hands thoroughly with cool water after use. It is also crucial to advise patients not to use the product with a heating pad or any heating device. Finally, patients with sensitive skin should be encouraged to consult their healthcare provider before using the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place, away from excessive heat or open flame to maintain its integrity and efficacy. Proper handling should be observed to ensure the product remains within the recommended storage conditions.

Additional Clinical Information

For patients aged 2 years and older, the recommended administration involves applying a thin film of the product over the affected areas up to four times daily, without the need for massage. For children under 2 years of age, it is advised to consult a physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)