Biofreeze

Description

BIOFREEZE® is a pain-relieving spray formulated with soothing menthol. It utilizes cryotherapy, known as The Cold Method®, to provide effective relief from pain. The product is available in a dosage form of 16 fluid ounces (473 mL).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints. Specifically, it is effective for conditions such as arthritis, backache, strains, 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, the recommended dosage is to spray the product onto the affected areas of the skin up to four times daily. It is not necessary to massage the area after application.

For children under 12 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. The use of this product in conjunction with other ointments, creams, sprays, or liniments is not recommended, as it may lead to unpredictable interactions. Application to irritated skin or in cases where excessive irritation develops is contraindicated to prevent further skin damage. Bandaging over the application site is not advised, as it may alter the product's efficacy. Additionally, the use of heating pads or devices in conjunction with this product is contraindicated due to the risk of increased irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from excessive heat or open flame.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin. During the application of this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Additionally, it is important to refrain from applying the product to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended. Patients should wash their hands with cool water after use and should not use the product in conjunction with heating pads or devices.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

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

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from excessive heat or open flame. Prior to use, individuals with sensitive skin are advised to consult a doctor.

When using this product, it is important to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, nor should it be used in conjunction with other ointments, creams, sprays, or liniments. Application to irritated skin or in cases where excessive irritation develops is also contraindicated. Bandaging the area after application is not recommended, and hands should be washed with cool water following use. Additionally, the product should not be used with heating pads or devices.

Patients are instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur. For those who are pregnant or breastfeeding, it is advisable to seek guidance from a health professional before use.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, or contact with a Poison Control Center should be made.

Drug Interactions

Co-administration of this medication with other topical formulations, such as ointments, creams, sprays, or liniments, is contraindicated. The use of heating pads or devices in conjunction with this medication is also not recommended, as it may lead to adverse effects.

There are no specific drug or laboratory test interactions identified for this medication. Therefore, no additional monitoring or dosage adjustments are necessary in relation to drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may use the product by spraying it onto the affected areas up to four times daily, with no need for massage. For children under 12 years of age, it is advised to consult a physician prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of Biofreeze menthol spray, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when considering this product for geriatric patients.

Due to the absence of clinical data specifically addressing the geriatric population, it is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or unusual responses to treatment. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when recommending this product to ensure safe and effective use.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 drug insert 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 absence of detailed 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 the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center without delay if the medication is accidentally ingested.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific medication involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are essential to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

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 accidentally ingested. Patients should be informed to monitor their condition closely and to report to their healthcare provider if symptoms worsen, persist for more than 7 days, or if symptoms clear up and then reoccur.

It is important to instruct patients to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. Patients should be cautioned against using the product in conjunction with other ointments, creams, sprays, or liniments, and to avoid application on irritated skin or if excessive irritation develops. Additionally, patients should be advised not to bandage the area after application.

Healthcare providers should emphasize the importance of washing hands thoroughly with cool water after using the product. Patients should also be informed not to use the product in combination with heating pads or devices. Finally, it is recommended that patients consult their healthcare provider before use if they have sensitive skin.

Storage and Handling

The product is supplied in a container that must be stored in a cool, dry place. It is essential to ensure that the lid is closed tightly to maintain the integrity of the product. Proper storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the spray to the affected areas up to four times daily, with no need for massage. For children under 12 years of age, consultation with a physician is recommended prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)