Biofreeze Overnight Gel

Description

BiOFREEZE® is a menthol-based pain-relieving gel formulated for topical application. It is presented in a gel dosage form, with a net volume of 3 fluid ounces (89 mL). The product is identified by the National Drug Code (NDC) 59316-121-10.

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.

Limitations of Use: There are no known 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 no more than 3 to 4 times daily. It is important to ensure that the application is limited to this frequency to avoid potential adverse effects.

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, hands should be washed thoroughly with cool water to prevent unintentional contact with other areas of the body or with other individuals.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

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

When using this product, it is imperative to adhere strictly to the directions provided. Users should avoid contact with the eyes and mucous membranes. The product must not be applied to wounds or damaged skin, nor should it be used on irritated skin or if excessive irritation develops. Additionally, it is advised not to bandage tightly or use in conjunction with a heating pad or device.

Special precautions should be taken for children aged 2 years to under 12 years; the product should only be used under adult supervision.

Users are advised to discontinue use and consult a healthcare professional if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; symptoms that persist for more than 7 days; symptoms that clear up and then recur within a few days; persistent arthritic pain for more than 10 days; or the presence of redness. This caution is particularly important for conditions affecting children under 12 years of age.

Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use.

It is essential to keep this product 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 without delay.

Side Effects

Patients using this product should be aware of several important warnings and adverse reactions. This product is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms for more than 7 days; or recurrence of symptoms after they have cleared up within a few days. Additionally, if arthritic pain persists for more than 10 days or if redness is present, medical advice should be sought.

Special considerations apply to specific populations. For conditions affecting children under 12 years of age, it is recommended to seek medical advice before use. Pregnant or breastfeeding individuals should also consult a healthcare professional prior to using this product.

It is crucial to keep this product 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 without delay.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. 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 Overnight Gel (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 infants and children under 2 years of age, consultation with a physician is advised prior to use. Additionally, caregivers are instructed to discontinue use and seek medical advice if any conditions affecting children under 12 years of age arise.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 breastfeeding infants are not fully established. It is essential for women of childbearing potential to seek medical advice 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 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20-25°C (68-77°F) to maintain optimal quality. It is essential to keep the product in a cool, dry place, away from direct sunlight to prevent degradation. Proper storage conditions are crucial for preserving the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)