Biofreeze Flexible Relief Strip

Description

BiOFREEZE® is a menthol-based pain-relieving patch designed to provide up to 8 hours of long-lasting pain relief. Each patch measures 10 inches by 2 inches (25.4 cm x 5 cm) and is packaged in a set of four extra-long strips. The product features strong adhesion to ensure it remains in place during movement, while its optimal thickness enhances comfort and flexibility. The National Drug Code (NDC) for BiOFREEZE® is 59316-004-04.

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

Adults and children aged 12 years 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 adhesive side to be applied directly to the site of pain. The remaining film must be carefully removed while ensuring the patch adheres firmly to the skin. The patch should remain in place for a maximum of 8 hours and may be used on the affected area no more than 3 to 4 times daily.

It is important to avoid stretching the patch during application to ensure comfort and prevent tightness. Additionally, patches should not be overwrapped or layered upon themselves. For optimal adhesion, the application site should be clean, dry, and smooth.

For children under 12 years of age, consultation with a physician is recommended prior to use. After application, hands should be washed thoroughly with cool water to maintain hygiene.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or use in conjunction with a heating pad or device, 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. If excessive irritation develops, application should be discontinued.

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 if symptoms persist beyond 7 days or resolve only to 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 contact a healthcare professional.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or irritated areas, and it is advised not to bandage tightly or use with heating pads or devices.

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

It is important for patients who are pregnant or breastfeeding to consult a healthcare professional before using this product. Furthermore, the product should be kept out of reach of children, and in the case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

There are no reported drug interactions associated with this medication. Additionally, there are no interactions identified between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

Geriatric Use

There is no specific information regarding the use of Biofreeze Flexible Relief Strip 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 changes in efficacy is advisable in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 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, 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 of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical response are vital in managing cases of overdosage to ensure patient safety and effective treatment.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 arthritic pain persists for more than 10 days or if redness is present, they should stop use and consult a healthcare professional.

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, damaged skin, or irritated skin, and should be advised to discontinue use if excessive irritation develops. Furthermore, patients should be instructed not to bandage the area tightly or use 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 route of administration for the medication is topical. For adults and children aged 12 years and older, the affected area should be cleaned and dried before applying the patch. The protective film should be partially peeled back, and the exposed patch applied to the site of pain. The remaining film should be carefully removed while pressing the patch to the skin, which can remain in place for up to 8 hours. It is recommended that the patch be used on the affected area no more than 3 to 4 times daily, ensuring that it is applied comfortably without stretching or overwrapping.

For children under 12 years of age, consultation with a physician is advised prior to use. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. Additionally, patients should wash their hands with cool water after applying the patch.

Drug Information (PDF)

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

View product document (PDF)