Biofreeze

Description

The product is a topical analgesic formulated for external use only. It contains menthol as the active ingredient, complemented by a blend of inactive ingredients. The cream is packaged in a tube, facilitating easy application. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including conditions such as arthritis, backache, strains, sprains, and bruises.

Healthcare professionals are advised to consult with patients who are pregnant or breastfeeding prior to recommending this medication, as specific nonteratogenic effects have not been detailed.

Dosage and Administration

For adults and children aged 12 years and older, a thin film of the medication should be applied to the affected area, not exceeding 3 to 4 applications per day.

In the case of children under 12 years of age, it is advised to consult a physician prior to use to determine appropriate treatment.

After application, it is important to wash hands 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 in cases where excessive irritation develops, as this may exacerbate the condition. Furthermore, tight bandaging or the use of heating pads or devices in conjunction with the product is contraindicated, as this may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only. This product must be used strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. It is imperative that the product is not applied to wounds, damaged skin, or irritated areas. If excessive irritation develops, the use of the product should be discontinued. Additionally, patients should be cautioned against tightly bandaging the area of application or using the product in conjunction with heating pads or devices.

Patients should be instructed to stop using the product 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.

This product should 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 should be aware that it is for external use only. It is essential to use the product only as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and if excessive irritation develops, use should be discontinued. Additionally, patients should refrain from tightly bandaging the area or using it in conjunction with heating pads or devices.

In clinical practice, patients are advised to stop use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur. Special consideration should be given to pregnant or breastfeeding individuals, who are encouraged to seek advice from a health professional before using the product.

It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary 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 under 12 years of age should consult a physician prior to use. For adolescents and children aged 12 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended 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, 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 safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human 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 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available 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. It is important to instruct patients to stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur.

Patients should be reminded to use the product only as directed. They should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or damaged skin. Additionally, patients should be informed not to use the product on irritated skin or if excessive irritation develops.

Healthcare providers should also emphasize that patients should not bandage the area tightly or use the product in conjunction with a heating pad or device.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

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)