Biofreeze Professional Roll-on

Description

BiOFREEZE® Professional Roll-On Menthol Pain Relieving Gel is presented in a dosage form of a gel, contained in a 3 fluid ounce (89 mL) roll-on applicator. This formulation is designed for topical application to provide relief from pain through the active ingredient menthol. The product is intended for professional use in pain management.

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

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 is limited to the specified 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 reactions. 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 irritation or other complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. It is imperative that the product is used only as directed to ensure safety and efficacy.

Contact with the eyes or mucous membranes must be avoided. The product should not be applied to wounds, damaged skin, or irritated skin. If excessive irritation develops, use should be discontinued immediately. Additionally, the product should not be bandaged tightly or used in conjunction with a heating pad or device, as this may exacerbate adverse effects.

Healthcare professionals should advise patients 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 resolve and then recur within a few days, medical advice should be sought. In cases of arthritic pain that persists for more than 10 days, the presence of redness, or conditions affecting children under 12 years of age, patients should also be instructed to seek medical attention.

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 should be made 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.

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

Patients should discontinue use and consult a healthcare professional 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 resolve 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, patients should seek medical advice.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Biofreeze Professional Roll-on (menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For external use only, this medication should be kept out of reach of children. In the event of ingestion, medical assistance or contact with a Poison Control Center is advised immediately.

Pediatric patients aged 2 years and older may apply a thin film to the affected area up to 3 to 4 times daily. For children under 2 years of age, consultation with a physician is required prior to use.

Healthcare professionals should advise caregivers to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if arthritic pain continues for more than 10 days, if redness is present, or in cases involving children under 12 years of age.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 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 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 monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

Nonclinical Toxicology

There is no information available regarding teratogenic effects. For non-teratogenic effects, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use. Additionally, there is no information provided in the nonclinical toxicology section, nor is there any data available concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be instructed to use the medication only as directed by their healthcare provider. It is important to avoid contact with the eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, patients should not apply the medication to wounds or damaged skin, as this could exacerbate the condition.

Healthcare providers should caution patients against applying the medication to irritated skin or if excessive irritation develops. Furthermore, patients should be informed not to bandage the area tightly or use the medication in conjunction with a heating pad or device, as this may increase the risk of adverse reactions.

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

The product 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 product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)