Biofreeze Roll-on

Description

BiOFREEZE® is a roll-on menthol pain-relieving gel designed for topical application. Each container contains 3 fluid ounces (89 mL) of the formulation. The product is identified by the National Drug Code (NDC) 59316-205-10. It is recommended to shake well before each use to ensure proper mixing of the ingredients.

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 does not exceed 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

The product is contraindicated for use 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. Tight bandaging or concurrent use with heating pads or devices is also contraindicated, as it may lead to increased risk of irritation or other complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. Healthcare professionals are advised to instruct patients to use the product strictly as directed. It is imperative to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and should not be used if excessive irritation develops. Additionally, patients should be cautioned against tightly bandaging the area of application or using it in conjunction with heating pads or devices.

Patients must be advised to discontinue use and consult a healthcare provider if they experience any of the following: pain, swelling, or blistering of the skin; worsening of the condition; persistence of symptoms beyond 7 days; or recurrence of symptoms after a brief improvement. Special attention should be given to patients with arthritic pain that persists for more than 10 days, the presence of redness, or those under 12 years of age.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional prior to use. 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 without delay.

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.

When using this product, patients are advised to avoid contact with the eyes and mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin, especially if excessive irritation develops. Additionally, patients should refrain from tightly bandaging the area or using it in conjunction with heating pads or devices.

Patients are instructed to stop use and consult a doctor if they experience pain, swelling, or blistering of the skin. If the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought. Furthermore, if arthritic pain persists for more than 10 days, or if redness is present, or if the product is being used on children under 12 years of age, patients should also seek medical attention.

Additional considerations include consulting a health professional if pregnant or breastfeeding. It is crucial to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For 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. It is advised to discontinue use and seek medical advice if the condition affects children under 12 years of age.

Geriatric Use

There is no specific information regarding the use of Biofreeze Roll-On in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of targeted data for 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 weighed, 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 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 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 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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation 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 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to consult a health professional if they are pregnant or breastfeeding before using the product. It is essential to emphasize the importance of using the product only as directed to ensure safety and efficacy.

Patients should be informed to avoid contact with the eyes and mucous membranes, as this could lead to irritation or adverse effects. Additionally, they should not apply the product to wounds or damaged skin, as this may exacerbate the condition or lead to complications.

Healthcare providers should also caution patients against applying the product to irritated skin or if they experience excessive irritation during use. It is important to instruct patients not to bandage the area tightly or use the product in conjunction with a heating pad or device, as this could increase the risk of adverse reactions.

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

The product is administered topically, with a recommended application of a thin film over the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a physician is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is also important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)