Biofreeze Overnight Roll-on

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for 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 2 years and older, a thin film of the medication should be applied to the affected area. This application may be performed up to 3 to 4 times daily, as needed.

For children under 2 years of age, it is recommended to consult a physician prior to use to ensure safety and appropriateness of 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

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame. When utilizing this product, it is imperative to adhere strictly to the following guidelines: use only as directed, avoid contact with the eyes and mucous membranes, and refrain from applying it to wounds or damaged skin. Additionally, it should not be applied to irritated skin or if excessive irritation develops. Bandaging should not be tight, nor should the product be used in conjunction with a heating pad or device. For children aged 2 years to under 12 years, use should only occur under adult supervision.

Healthcare professionals should advise patients to discontinue use and seek medical attention if they experience pain, swelling, or blistering of the skin. Patients should also be instructed to contact their doctor if their condition worsens, if symptoms persist 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, or if the patient is a child under 12 years of age, medical consultation is necessary.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. It is crucial to use the product only as directed and to avoid contact with the eyes or mucous membranes. Application to wounds, damaged skin, or irritated skin should be avoided, and the product should not be bandaged tightly or used in conjunction with a heating pad or device.

In clinical practice, patients are advised to discontinue 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. For patients experiencing arthritic pain, if symptoms persist for more than 10 days, or if redness is present, it is recommended to stop use and consult a doctor. Special caution is advised for children aged 2 years to under 12 years, who should use the product only under adult supervision.

For pregnant or breastfeeding individuals, it is advisable to consult a healthcare professional before use to ensure safety for both the mother and child.

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 Overnight Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years to under 12 years should use this medication only under adult supervision. For both adults and children aged 2 years and older, the recommended application is to rub a thin film over the affected area no more than 3 to 4 times daily. In children under 2 years of age, it is advised to consult a physician prior to use. Additionally, if any conditions affecting children under 12 years of age are present, the use of this medication should be discontinued, and a doctor should be consulted.

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 discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at a temperature range of 20-25°C (68-77°F).

For optimal preservation, the product should be kept in a cool, dry place, ensuring it is protected from direct sunlight. Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)