Biofreeze Foam

Description

BIOFREEZE® is a menthol-based pain-relieving liquid formulated for topical application. It is presented in a lightweight foam dosage form that rubs in easily and dries quickly, providing a fast-acting solution for pain relief. The product is packaged in a 3 fluid ounce (88 mL) container. The National Drug Code (NDC) for this formulation is 59316-991-10.

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.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, a thin film of the product should be applied to 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 recommended to consult a physician prior to use.

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

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. Additionally, tight bandaging or use in conjunction with heating pads or devices is contraindicated, as this may lead to increased irritation or adverse effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users must avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged skin, or irritated areas. In cases where excessive irritation develops, discontinuation of use is advised. Additionally, the product should not be bandaged tightly or used in conjunction with heating pads or devices.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; or recurrence of symptoms after a brief improvement. Furthermore, 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 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 flame.

During use, patients are advised to 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. Additionally, patients should refrain from tightly bandaging the area or using the product in conjunction with heating pads or devices.

Patients are instructed to discontinue 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 the recommendation for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. The product should be kept out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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 Foam (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a physician before use. For adolescents and children aged 12 years and older, the recommended application is to rub a thin film 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.

Due to the lack of data, it is advisable to closely monitor elderly patients for any potential adverse effects or changes in efficacy. Individualized assessment and consideration of the patient's overall health status and concurrent medications are recommended to ensure safe and effective use in 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 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 not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 inform 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 should be reminded to follow the directions carefully. They should avoid contact with the eyes and mucous membranes, and 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 not 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 and stability. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Additionally, 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 product is administered topically, with a recommended application of a thin film to the affected area for adults and children aged 12 years and older, not exceeding 3 to 4 times daily. For children under 12 years of age, consultation with a physician is advised.

Clinicians should counsel patients that the product is for external use only and is flammable; it should be kept away from excessive heat or open flames. Patients are instructed to use the product as directed, avoiding contact with eyes and mucous membranes, and not to apply it to wounds, damaged, or irritated skin. They should refrain from tight bandaging or using heating devices in conjunction with the product. Patients should discontinue use and consult a doctor if they experience pain, swelling, blistering, worsening conditions, or if symptoms persist beyond specified durations. Pregnant or breastfeeding individuals should seek professional advice before use, and the product should be kept out of reach of children, with immediate medical assistance sought if ingested.

Drug Information (PDF)

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

View product document (PDF)