Biofreeze Professional

Description

BiOFREEZE® PROFESSIONAL is a menthol pain-relieving spray available in a 4 fluid ounce (118 mL) dosage form. The product features a 360° spray mechanism, allowing for versatile application. For initial use, it is necessary to press down firmly to activate the sprayer. The National Drug Code (NDC) for this product is 59316-834-20.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 are instructed to apply the spray to the affected area up to 3 to 4 times daily. It is not necessary to massage the area after application. For children under 12 years of age, consultation with a physician is recommended prior to use.

After application, it is essential to wash hands thoroughly with cool water to prevent accidental contact with sensitive areas.

Contraindications

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

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flames 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 this 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 resolve and then recur within a few days. Additionally, if arthritic pain continues 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 a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This 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.

While 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 doctor if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms for more than 7 days; or if symptoms clear up and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days or if redness is present, medical advice should be sought.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

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 Professional (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 and children 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

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. 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data may impact the drug's efficacy and safety profile in this population. Regular monitoring of renal function is advisable to ensure patient safety.

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, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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 strategies.

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

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 these contexts.

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 stop using the product and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be informed to discontinue use 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 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 provided and to avoid contact with the eyes and mucous membranes. They should not apply the product to wounds, damaged skin, or irritated skin, and should discontinue use if excessive irritation develops. Furthermore, patients should be cautioned 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 and stability. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. It is essential to keep the product in a cool, dry place, away from direct sunlight, to prevent any degradation or compromise of quality. Proper storage conditions are crucial for preserving the product's intended use and effectiveness.

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 important to keep the product 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 Professional, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)