Herbal Freeze

Description

No relevant information is available for SPL code 34089-3, and therefore, a detailed description cannot be provided.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including conditions such as arthritis, simple backaches, 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, the recommended dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The gel should be rubbed in thoroughly until fully absorbed.

For children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with any heat sources.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to ensure safety for both the mother and child.

When utilizing this product, it is essential to avoid tightly bandaging the area of application and to prevent contact with the eyes. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Users should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is crucial to ensure appropriate management and care.

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and should not be applied to wounds or damaged skin. Additionally, the product should not be used in conjunction with a heat source. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

While using this product, patients should avoid tightly bandaging the area of application and ensure that the product does not come into contact with the eyes. It is also crucial to keep the product out of reach of children.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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 Herbal Freeze (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. It is intended for external use only and should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heat source.

For children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily, ensuring thorough rubbing in until the gel is fully absorbed. For children under 2 years of age, consultation with a doctor is necessary prior to use.

Healthcare professionals should emphasize the importance of avoiding tight bandaging and contact with the eyes during application.

Geriatric Use

There is no specific information available 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. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare 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 not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily. Patients should rub the gel into the affected area thoroughly until it is fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)