Biofreeze Colorless Roll-on

Description

BiOFREEZE® is a menthol-based pain-relieving gel formulated for topical application. Each unit contains 3 fluid ounces (89 mL) of a colorless gel designed to provide a cooling effect to alleviate pain. The product is identified by the National Drug Code (NDC) 59316-206-10. 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 of muscles and joints associated with 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 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 application to wounds or damaged skin due to the potential for adverse effects. It should not be applied to irritated skin or in cases where excessive irritation develops, as this may exacerbate the condition. Additionally, 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 is flammable; therefore, it must be kept away from excessive heat or open flame.

It is imperative that the product is used only as directed. Healthcare professionals should advise patients 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 on irritated skin or 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 should be instructed 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; or if symptoms persist for more than 7 days or resolve and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, medical advice should be sought.

In the event of accidental ingestion, immediate medical assistance should be obtained, 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.

During use, patients are advised to avoid contact with the eyes and mucous membranes. It is also important not to apply the product to wounds or damaged skin, nor to use it on irritated skin or if excessive irritation develops. Additionally, patients should refrain from tightly bandaging the area of application or using the product in conjunction with a heating pad or device.

Patients should discontinue use and consult a healthcare professional if they experience any of the following adverse reactions: pain, swelling, or blistering of the skin; worsening of the condition; or if symptoms persist for more than 7 days or resolve and then recur within a few days. Furthermore, if arthritic pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age, patients should seek medical advice.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Biofreeze Colorless 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 important to note that any condition affecting children under 12 years of age that persists should prompt consultation with a healthcare professional.

Geriatric Use

There is no specific information regarding the use of Biofreeze Colorless 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 changes in efficacy is advisable when this product is used in the geriatric population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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

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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 keep the medication out of reach of children to prevent accidental ingestion. In the event of swallowing the medication, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to use the medication only as directed by their healthcare provider. It is important to avoid contact with the eyes and mucous membranes, as this may lead to irritation or adverse effects. Additionally, patients should not apply the medication to wounds or damaged skin, as this could exacerbate the condition.

Healthcare providers should caution patients against using the medication on irritated skin or if excessive irritation develops. Furthermore, patients should be informed not to bandage the area tightly or use the medication in conjunction with a heating pad or device, as this may increase the risk of adverse reactions.

Storage and Handling

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

Additional Clinical Information

The medication 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 medication out of reach of children; if ingested, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)