Biofreeze Overnight Relief

Description

BIOFREEZE® is a menthol-based topical analgesic formulated as an overnight pain relief patch. Each patch measures 5.125 inches by 2.6 inches (13 cm by 6.6 cm) and is designed to provide effective pain relief while remaining comfortably in place throughout the night. The patches are infused with lavender essential oil, contributing to a soothing scent. Their optimal thickness ensures both comfort and flexibility, allowing for ease of use during sleep. Each package contains four patches.

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 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 adhesive side to be applied directly to the site of pain. After positioning the patch, the remaining film should be carefully removed while pressing the patch firmly against the skin. The patch should be left in place for a maximum duration of 8 hours. It is recommended that the patch not be applied to the affected area 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 for use 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 if 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. Healthcare professionals should advise patients to use this product strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be 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 the product in conjunction with heating pads or devices, as this 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 for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought. For arthritic pain, if symptoms persist for more than 10 days or if redness is observed, patients should also seek medical attention.

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 should be made without delay.

Side Effects

Patients using this product should be aware that it is 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 skin, especially if excessive irritation develops. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad or device.

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. If the condition worsens, or if symptoms persist for more than 7 days or resolve 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.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Furthermore, the product should be kept out of reach of children, and in the case of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Biofreeze Overnight Relief (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 prior to use. For adolescents aged 12 years and older, the recommended application involves cleaning and drying the affected area, then partially peeling back the protective film to apply the exposed patch to the site of pain. The remaining film should be carefully removed while pressing the patch to the skin, and it may be left in place for up to 8 hours. This patch should not be applied to the affected area more than 3 to 4 times daily.

It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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 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 no specific data available regarding the excretion of this medication in 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 the use of this medication. 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

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

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

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.

For those experiencing arthritic pain, it is important to inform them to stop use and consult a doctor if the pain persists for more than 10 days or if redness is present.

When using this product, patients must be instructed to use it only as directed. They should avoid contact with the eyes and mucous membranes, and not apply the product to wounds or damaged skin. Patients should also be cautioned against using the product on irritated skin or if excessive irritation develops. Furthermore, they should not bandage the area tightly or use it in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. 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

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 to expose 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, and it can be left in place for up to 8 hours. The patch should not be used on the affected area more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the medication out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)