Biofreeze Foot Cream

Description

BiOFREEZE® is a menthol-based pain-relieving cream formulated for topical application. It is presented in a foot cream dosage form, designed to provide a cooling effect to alleviate pain. The product is packaged in a net weight of 4 ounces (113.3 grams). The National Drug Code (NDC) for this formulation is 59316-001-20.

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 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 important to ensure that the application is limited to this frequency to avoid potential adverse effects.

For children under 12 years of age, it is recommended to consult a physician prior to use to determine appropriate dosing and administration.

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 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 if excessive irritation develops, as this may exacerbate the condition. It is also contraindicated to bandage tightly or 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 should be utilized strictly as directed to ensure safety and efficacy.

General precautions must be observed to prevent adverse effects. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or areas of irritation. In cases where excessive irritation develops, discontinuation of use is advised. Additionally, the product should not be tightly bandaged or used in conjunction with heating pads or devices, as this may exacerbate irritation or lead to other complications.

Healthcare professionals should instruct patients to stop 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 temporary improvement. Furthermore, if arthritic pain continues for more than 10 days or if redness is observed, medical consultation is recommended.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or irritated areas, and it is advised not to bandage tightly or use in conjunction with heating pads or devices.

In the event of adverse reactions, patients are instructed to stop use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought. Patients should also seek medical attention if arthritic pain persists for more than 10 days or if redness is present.

It is important for patients who are pregnant or breastfeeding to consult a healthcare professional before using this product. Furthermore, the product should be kept out of reach of children, and in the case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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 Foot Cream (menthol). 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 apply a thin film over the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of Biofreeze Foot Cream, as the drug insert does not provide data on geriatric use. Therefore, healthcare providers should exercise caution when recommending this product to geriatric patients.

It is advisable to consider the overall health status and any comorbidities of elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Monitoring for any adverse effects or unusual responses to treatment is recommended, given the lack of targeted studies in this population.

Healthcare providers should also be mindful of potential interactions with other medications that elderly patients may be taking, and adjust recommendations accordingly.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised 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 discussing the application of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. They should also be advised against using the product on irritated skin or if excessive irritation develops. Furthermore, patients should be instructed not to 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 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

For adults and children aged 12 years and older, the recommended administration involves applying a thin film over the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a physician prior to use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)