Biofreeze

Description

No description information is available for the specified drug.

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 appropriate dosing and administration.

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. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion and potential complications. Additionally, the use of heating pads or devices in conjunction with this product is not advised, as it may increase the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame. The contents are under pressure; puncturing or incinerating the container is strictly prohibited. Additionally, it should not be stored at temperatures exceeding 120°F.

Healthcare professionals should advise patients to consult a doctor prior to use if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; symptoms persisting for more than 7 days; or if symptoms clear up and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days or if redness is present, medical consultation is recommended.

While using this product, it is essential 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. Application to irritated skin or in cases of excessive irritation is contraindicated. Bandaging the area after application is not advised. Users should wash their hands with cool water after use and avoid using the product with heating pads or devices. It should be stored in a cool, dry place.

Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Pregnant or breastfeeding individuals should consult a healthcare professional before using this product.

This product must be kept 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.

Side Effects

Patients using this product may experience a range of adverse reactions. It is important for patients to consult a healthcare professional if they experience pain, swelling, or blistering of the skin. Additionally, if the condition worsens, or if symptoms persist for more than 7 days, or clear up and recur within a few days, patients should seek medical advice. Persistent arthritic pain lasting more than 10 days, or the presence of redness, also warrants consultation with a healthcare provider.

Patients are advised to discontinue use and consult a doctor if their condition worsens, or if symptoms persist beyond 7 days, or if they clear up and then recur.

While using this product, patients should take precautions to avoid contact with the eyes or mucous membranes and should not apply it to wounds or damaged skin. The product should not be used in conjunction with other ointments, creams, sprays, or liniments, nor should it be applied to irritated skin or if excessive irritation develops. Bandaging the area after application is not recommended, and patients should wash their hands with cool water after use. The use of heating pads or devices in conjunction with this product is also discouraged.

This product is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flames. The contents are under pressure, and patients should not puncture or incinerate the container. It is crucial to store the product in a cool, dry place and not at temperatures exceeding 120°F. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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, without the need for massage. For children under 12 years of age, it is advised to consult a physician prior to use.

It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

Geriatric Use

There is no specific information regarding the use of Biofreeze menthol spray in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or unique responses in this population. It is advisable to consider individual patient factors and clinical judgment when determining the appropriateness of this treatment for geriatric patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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 considering the use of this medication during lactation.

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 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, 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

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 elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 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 recur.

When using this product, it is essential to avoid contact with the eyes and mucous membranes. Patients should not apply the product to wounds or damaged skin, nor should they use it in conjunction with other ointments, creams, sprays, or liniments. They should also refrain from applying the product to irritated skin or if excessive irritation develops. Additionally, patients should not bandage the area after application and must wash their hands with cool water following use. It is important to inform patients not to use the product with a heating pad or device and to store it in a cool, dry place.

Patients should be encouraged to consult a doctor before using the product if they experience pain, swelling, or blistering of the skin. They should also seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Furthermore, patients should be advised to contact a healthcare professional if arthritic pain persists for more than 10 days or if redness is present.

Storage and Handling

The product is supplied in a container that is designed to maintain its integrity under standard handling conditions. It is essential to store the product in a cool, dry place, ensuring that it is kept away from excessive heat or open flame. The storage temperature must not exceed 120°F to prevent any compromise of the product's quality and safety.

As the contents are under pressure, it is critical to avoid puncturing or incinerating the container. Proper handling and storage are vital to ensure the product remains effective and safe for use.

Additional Clinical Information

Adults and children aged 12 years and older are instructed to apply the spray to the affected areas no more than four times daily, with no need for massage. For children under 12 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to avoid contact with the eyes and mucous membranes, and to refrain from applying the product to wounds or damaged skin. It is advised not to use the spray in conjunction with other ointments, creams, sprays, or liniments, and to avoid application on irritated skin or in cases of excessive irritation. Patients should not bandage the area after application and should wash their hands with cool water post-use. Additionally, the product should not be used with heating pads or devices and should be stored in a cool, dry place.

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)