Biofreeze

Description

The product is a topical analgesic cream identified by SPL code 34089-3. It contains Menthol as the active ingredient at a concentration of 3.5% (w/w). The formulation includes several inactive ingredients, such as Water, Carbomer, Glycerin, Triethanolamine, and Propylene Glycol, among others. The cream is characterized by its white to off-white color and exhibits a smooth, homogenous consistency.

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.

Limitations of Use: There are no known 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 medication should be applied to the affected areas, with a maximum frequency of four 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 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. Concurrent use with other ointments, creams, sprays, or liniments is not recommended, as this may lead to unpredictable interactions. The product should not be applied to irritated skin or in cases where excessive irritation develops, as this could exacerbate the condition. Bandaging the area after application is contraindicated to prevent occlusion. Additionally, the use of heating pads or devices in conjunction with the product is not advised, as this may increase the risk of irritation or other adverse reactions.

Warnings and Precautions

For external use only.

Healthcare professionals should advise patients to consult a physician prior to use if they have sensitive skin. During the application of this product, it is imperative 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 is contraindicated, and if excessive irritation occurs, the product should be discontinued. Bandaging the area after application is not recommended.

Patients should wash their hands thoroughly with cool water following use. Additionally, the product should not be used in conjunction with heating pads or devices. It is essential to store the product in a cool, dry place to maintain its efficacy.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

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 using this product should be aware that it is for external use only. It is advised to consult a doctor prior to use if the patient has sensitive skin. During application, patients must avoid contact with the eyes or mucous membranes and should not apply the product to wounds or damaged skin. Additionally, it is important not to use the product in conjunction with other ointments, creams, sprays, or liniments, and to refrain from applying it 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 following use. The product should not be used with heating pads or devices, and it should be stored in a cool, dry place.

Patients are advised 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. For those who are pregnant or breastfeeding, it is recommended to seek advice from a health professional before using the product.

It is crucial to keep this product 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 established.

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 interactions identified between this medication and laboratory tests. Therefore, no adjustments or special monitoring related to laboratory tests are necessary.

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 apply a thin film of the medication over affected areas up to four times daily, without the need for massage. For children under 12 years of age, it is recommended to consult a physician prior to use.

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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently 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 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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 these contexts.

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 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 important to avoid contact with the eyes and mucous membranes. Patients should be cautioned against applying the product to wounds or damaged skin, and they should not use it in conjunction with other ointments, creams, sprays, or liniments. Additionally, patients should 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 using the product and should not use it in combination with a heating pad or any heating device. It is also essential to store the product in a cool, dry place.

Healthcare providers should encourage patients to consult a doctor before using the product if they have sensitive skin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

Additional Clinical Information

For patients aged 12 years and older, the recommended administration involves applying a thin film of the product over 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. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)