Biofreeze

Description

BiOFREEZE® is a menthol-based pain-relieving spray designed for topical application. Each container has a net volume of 4 fluid ounces (118 mL) and features a 360° spray mechanism, allowing for versatile application angles. The product is identified by the National Drug Code (NDC) 59316-114-25. For initial use, it is necessary to press down firmly to activate the sprayer.

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 12 years and older, the recommended dosage is to spray the product onto the affected area no more than 3 to 4 times daily. It is not necessary to massage the area after application.

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

After application, it is important to wash hands thoroughly with cool water to prevent any unintended exposure.

Contraindications

The product is contraindicated for application to wounds or damaged skin, as this may exacerbate the condition. It should not be used on irritated skin or if excessive irritation develops, due to the potential for further skin damage. Additionally, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to adverse effects.

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. The contents are under pressure; puncturing or incinerating the container is strictly prohibited to avoid potential injury.

Storage conditions are critical; do not store the product at temperatures exceeding 120°F to maintain its integrity and safety.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; symptoms that persist for more than 7 days; or if symptoms clear up and then recur within a few days. Additionally, if arthritic pain persists for more than 10 days or if redness is observed, medical consultation is recommended.

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

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 flames. The contents are under pressure, and users should not puncture or incinerate the container. Additionally, it is crucial to store the product at temperatures not exceeding 120°F.

When using this product, patients should avoid contact with the eyes and mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin, especially if excessive irritation develops. Users are advised against tightly bandaging the area or using the product in conjunction with heating pads or devices.

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. Furthermore, if arthritic pain persists for more than 10 days or if redness is present, patients should also seek medical attention.

Additional considerations include consulting a healthcare professional if pregnant or breastfeeding before using the product. It is essential to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 (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. For adolescents and adults aged 12 years and older, the recommended dosage is to spray on the affected area no more than 3 to 4 times daily; massage of the area is not necessary.

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 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 regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed 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 advise 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 reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and should 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 be advised not to 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 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

Patients aged 12 years and older are advised to apply the spray to the affected area no more than 3 to 4 times daily, with no need for massage. For children under 12 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. It is also important to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

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)