Biofreeze Professional

Description

BiOFREEZE® PROFESSIONAL is a menthol pain-relieving gel formulated for topical application. Each container holds 4 fluid ounces (118 mL) of the gel. The product is identified by the National Drug Code (NDC) 59316-115-20.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of 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 area no more than 3 to 4 times daily. It is important to ensure that the application does not exceed 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 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 in cases where excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or to 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 is flammable; therefore, it must be kept away from excessive heat or open flame.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users should avoid contact with the eyes and mucous membranes. Application to wounds or damaged skin is contraindicated, as is use on irritated skin or in cases where excessive irritation develops. Additionally, the product should not be applied with tight bandaging or in conjunction with heating pads or devices.

Discontinue use and consult a healthcare professional if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; recurrence of symptoms after a brief improvement; arthritic pain lasting more than 10 days; presence of redness; or if the product is being used on children under 12 years of age.

Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use. 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 precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

During use, patients should avoid contact with the eyes and mucous membranes. It is advised not to apply the product to wounds or damaged skin, and to refrain from using it on irritated skin or if excessive irritation develops. Additionally, patients should not bandage the area tightly or use the product in conjunction with a heating pad or device.

Patients are instructed to stop use and consult a doctor if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days or clear up and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical advice should be sought.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific dosage adjustments or monitoring recommendations 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 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended dosage is to apply a thin film over the affected area no more than 3 to 4 times daily. It is advised to discontinue use and seek medical advice if the condition affects children under 12 years of age.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Biofreeze Professional Gel. As there is no available information regarding geriatric use, healthcare providers should exercise caution when administering this product to patients aged 65 and older. It is advisable to monitor these patients closely for any adverse effects or unexpected responses to treatment, given the general considerations for increased sensitivity 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 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 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 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 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. 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 patients to stop use and consult a doctor if the pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

When using this product, patients should 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, damaged skin, or irritated skin. Patients should also 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 degradation. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin film over the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised 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 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)