Biofreeze Precision Relief Pen

Description

BiOFREEZE® is a menthol-based pain-relieving liquid formulated for topical application. Each Precision Relief Pen contains 1.15 fluid ounces (34 mL) of the product. The National Drug Code (NDC) for this formulation is 59316-830-38. The product is designed to provide a cooling sensation to alleviate pain.

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

Adults and children 12 years of age and older should shake the product well before use. The applicator pen should be pressed straight down onto the affected area and held until the tip is fully soaked with the liquid. With light pressure, the liquid should be dabbed onto the skin and allowed to dry. The product may be applied to the affected area no more than 3 to 4 times daily; massage of the area is not necessary.

For children under 12 years of age, it is recommended to consult a physician prior to use.

After application, hands should be washed with cool water to ensure cleanliness.

Contraindications

The product is contraindicated for application to wounds or damaged skin, as well as to irritated skin or in cases where excessive irritation develops. Additionally, it should not be used with tight bandaging or in conjunction with heating pads or devices, due to the potential for increased irritation or adverse effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

When utilizing this product, it is imperative to adhere strictly to the directions provided. Users must avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged skin, or irritated areas. In cases where excessive irritation develops, application should be discontinued. Additionally, the product should not be bandaged tightly or used in conjunction with heating pads or devices.

Healthcare professionals should advise patients to stop use and consult a physician if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; symptoms that persist for more than 7 days or resolve only to recur within a few days; or if arthritic pain continues for more than 10 days, particularly in the presence of redness.

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 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. If excessive irritation develops, application should be discontinued. Additionally, patients should not bandage the area tightly or use the product in conjunction with a heating pad or device.

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, patients should also seek medical attention.

Additional considerations include the recommendation for pregnant or breastfeeding individuals to consult a health professional before use. The product should be kept out of reach of children, and in the event of ingestion, immediate medical help or contact with a Poison Control Center is advised.

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 Precision Relief Pen (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 adults aged 12 years and older, it is recommended to shake the product well before use. The application involves pressing the pen straight down onto the affected area and holding it until the tip is fully soaked with liquid. The solution should then be dabbed onto the skin using light pressure and allowed to dry. The product may be applied to the affected area no more than 3 to 4 times daily, and massaging the area is not necessary.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, 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 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 mothers.

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, 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any pain, swelling, or blistering of the skin. Additionally, they should be advised to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

For those experiencing arthritic pain, it is important to inform them to stop use and consult a doctor if the pain persists for more than 10 days or if redness is present.

When discussing the application of this product, healthcare providers should emphasize the importance of using it only as directed. Patients should be cautioned to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds, damaged skin, or irritated skin. They should also be advised against tightly bandaging the area or using the product in conjunction with a heating pad or device.

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) and kept 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 product is administered topically, with specific instructions for different age groups. Adults and children aged 12 years and older should shake the product well before use, apply it by pressing the pen straight down onto the affected area until the tip is fully soaked, and then dab it onto the skin, allowing it to dry. This application can be done up to 3 to 4 times daily, without the need for massage. For children under 12 years of age, consultation with a physician is recommended prior to use.

Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional before using the product. Additionally, it is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)