Biofreeze

Description

BiOFREEZE® is a menthol-based pain-relieving patch designed to provide up to 8 hours of long-lasting relief from sore muscles, simple backaches, and joint pain. Each patch measures 5.5 inches by 3.94 inches (14 cm by 10 cm) and is available in a package containing 12 large patches. The product features a proven cold therapy formula and is constructed from flexible fabric to ensure superior performance and comfort. The National Drug Code (NDC) for this product is 59316-992-08.

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.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older should begin by cleaning and drying the affected area. The protective film of the patch should be partially peeled back, allowing the exposed patch to be applied directly to the site of pain. While pressing the patch to the skin, the remaining film should be carefully removed. The patch should be left in place for a maximum duration of 8 hours. It is recommended that the patch be used on the affected area no more than 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a physician prior to use.

After application, hands should be washed thoroughly with cool water to ensure cleanliness.

Contraindications

The product is contraindicated in the following situations:

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

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is imperative that the product is not applied to wounds, damaged skin, or areas of irritation. Should excessive irritation develop, discontinuation of use is recommended.

Patients should be cautioned against tightly bandaging the area of application or using heating pads or devices in conjunction with this product, as these practices may exacerbate adverse effects.

In the event of adverse reactions, patients are instructed to stop use and consult a healthcare provider if they experience pain, swelling, or blistering of the skin. Additionally, if the condition worsens or symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought. For those experiencing arthritic pain that lasts longer than 10 days or if redness is observed, it is essential to seek medical attention.

This product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware that it is for external use only. It is essential to use the product only as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and care should be taken to avoid excessive irritation. Additionally, patients should not bandage the area tightly or use it in conjunction with a heating pad or device.

In the event of adverse reactions, patients are advised to stop use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. If the condition worsens, or if symptoms persist for more than 7 days or clear up and recur within a few days, medical advice should be sought. Furthermore, if arthritic pain persists for more than 10 days or if redness is present, patients should also seek medical attention.

For pregnant or breastfeeding individuals, it is recommended to consult a healthcare professional before using this product. It is crucial to keep the product out of reach of children, and if swallowed, immediate medical help should be sought or contact with a Poison Control Center should be made.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and children aged 12 years and older, the affected area should be cleaned and dried prior to application. The protective film of the patch should be partially peeled back, exposing the adhesive side, which is then applied to the site of pain. The remaining film should be carefully removed while pressing the patch to the skin. The patch may be left in place for up to 8 hours and should not be used on the affected area more than 3 to 4 times daily.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the patient's clinical presentation. Continuous evaluation and appropriate interventions should be implemented as necessary to ensure patient safety and recovery.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also important to inform patients that if they experience arthritic pain that persists for more than 10 days or if redness is present, they should stop use and consult a doctor.

When discussing the application of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds or damaged skin, nor should they use it on irritated skin or if excessive irritation develops. Furthermore, patients should be advised against tightly bandaging the area or using the product in conjunction with a heating pad or device.

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) and kept 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

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily on the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

No further information is available regarding laboratory tests, abuse potential, 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)