Biofreeze Professional Colorless

Description

BiOFREEZE® PROFESSIONAL is a colorless gel formulation designed for pain relief, containing menthol as its active ingredient. The product is available in a dosage form of 32 fluid ounces (1 quart), equivalent to 946 milliliters. The National Drug Code (NDC) for this product is 59316-116-40.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains in muscles and joints associated with 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 2 years and older, a thin film of the medication should be applied to the affected areas no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of treatment.

After application, hands should be washed thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

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

It is imperative to use this product only as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated. Additionally, the product should not be applied to irritated skin or if excessive irritation develops. Patients should be cautioned against tightly bandaging the area of application or using it in conjunction with heating pads or devices.

Patients should be instructed to discontinue use and consult a healthcare provider 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; recurrence of symptoms after clearing within a few days; arthritic pain lasting more than 10 days; presence of redness; or if the product is being used on children under 12 years of age.

In the event of ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

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. Users are advised to avoid contact with the eyes and mucous membranes, and it should not be applied to wounds, damaged skin, or irritated skin. If excessive irritation develops, application should be discontinued. Additionally, the product should not be bandaged tightly or used in conjunction with heating pads or devices.

Patients are instructed to stop use and consult a doctor 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 then recur within a few days, medical advice should be sought. In cases where arthritic pain persists for more than 10 days or if redness is present, patients should also seek medical attention. Special caution is advised for conditions affecting children under 12 years of age.

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 Colorless (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For adults and children aged 2 years and older, the recommended application is to rub a thin film over the affected areas no more than 3 to 4 times daily.

It is important to note that any conditions affecting children under 12 years of age should be discussed with a healthcare professional if symptoms persist.

Geriatric Use

There is no specific information regarding the use of Biofreeze Professional Colorless Gel in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 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 absence of 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 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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that they should monitor for any signs of pain, swelling, or blistering of the skin. If these symptoms worsen, persist for more than 7 days, or if they clear up and then recur within a few days, patients should contact their healthcare provider. Additionally, patients experiencing arthritic pain that lasts longer than 10 days, or those who notice redness, should also seek medical advice.

Patients must be instructed to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. It is essential to inform patients not to apply the product to 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 adheres to the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25°C (68-77°F). It is essential to keep the product in a cool, dry place, ensuring it is protected from direct sunlight to maintain its integrity and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply a thin film of the medication over the affected areas no more than 3 to 4 times daily. For children under 2 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 before using the product. Additionally, it is crucial to keep the medication out of reach of children; if ingested, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)