Biofreeze Colorless

Description

BiOFREEZE® is a menthol-based pain-relieving gel formulated to provide a cooling effect. It is presented as a colorless gel in a dosage form of 3 fluid ounces (89 mL). The product is identified by the National Drug Code (NDC) 59316-103-12.

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, not exceeding 3 to 4 applications per day. For children under 2 years of age, it is recommended to consult a physician prior to use.

After application, it is important to wash hands thoroughly with cool water to prevent accidental contact with other areas of the body or with other individuals.

Contraindications

The product is contraindicated 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. It is also contraindicated to bandage tightly or use in conjunction with a heating pad or device, as this 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.

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. Users must avoid tightly bandaging the area or using it in conjunction with a heating pad or device.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: pain, swelling, or blistering of the skin; worsening of the condition; symptoms persisting 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, if redness is present, or in cases involving children under 12 years of age, medical advice should be sought.

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 that it is intended for external use only. It is crucial to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds, damaged skin, or irritated areas. Additionally, patients should refrain from tightly bandaging the area or using heating pads or devices in conjunction with the product.

In the event of adverse reactions, patients are advised to discontinue use and consult a healthcare professional if they experience pain, swelling, or blistering of the skin. 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. Furthermore, if arthritic pain continues 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 also seek medical attention.

Additional considerations include the recommendation for pregnant or breastfeeding individuals to consult a healthcare professional prior to use. It is important to keep the product out of reach of children, and in the case of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Biofreeze Colorless (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. Healthcare professionals should advise caregivers to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, if symptoms clear and then recur within a few days, if arthritic pain persists for more than 10 days, if redness is present, or in cases involving children under 12 years of age.

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 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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the 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, if redness is present, or if the product is being used on children under 12 years of age.

When discussing the application of the 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

Patients aged 2 years and older are advised to apply a thin film of the medication over the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended 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, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

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

View product document (PDF)