Biofreeze Dry Stick

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 12 years and older, the recommended dosage involves turning the dial to dispense the product and applying a thin film to the affected area. This application should be performed by gently rubbing the product into the skin, not exceeding 3 to 4 times daily.

For children under 12 years of age, it is advised to consult a physician prior to use to determine appropriate treatment.

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

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding unless directed by a healthcare professional. Additionally, the 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 is advised.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. Healthcare professionals should advise 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. If excessive irritation develops, use should be discontinued. Additionally, patients should be cautioned against tightly bandaging the area of application or using the product in conjunction with heating pads or devices.

Patients are instructed to stop use and consult a healthcare provider 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 observed, patients should seek medical attention.

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. It is crucial to use the product only as directed and to avoid contact with the eyes or mucous membranes. Application to wounds, damaged skin, or irritated skin should be strictly avoided. Additionally, patients should not bandage the area tightly or use the product in conjunction with a heating pad or device.

In the event of adverse reactions, patients are advised 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 clear up 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. These precautions are essential to ensure the safe and effective use of the product.

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 Dry Stick (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 children aged 12 years and older, the recommended application is a thin film rubbed over the affected area, not to exceed 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of Biofreeze Dry Stick, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when recommending this product to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or unexpected responses when using Biofreeze Dry Stick. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this product for geriatric patients.

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 in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 consult a health professional if they are pregnant or breastfeeding before using the medication. It is important for patients to understand the potential risks and benefits associated with the use of the medication during these periods.

Additionally, healthcare providers should emphasize the importance of keeping the medication out of reach of children. Patients should be informed that if the medication is swallowed, they must seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring the safety of both patients and their families.

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 its efficacy. 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 quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)