Fast Freeze Pain Relieving Continuous

Description

FAST FREEZE® is a pain-relieving topical spray formulated to provide immediate relief for sore muscles, strains, sprains, and joint pain. This continuous spray features invigorating cooling menthol, delivering a greaseless and stain-free application. The formulation includes natural ingredients such as Vitamin E, Aloe, and Ilex, contributing to its soothing properties. Each container contains 4 oz (118 mL) of the product.

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, 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 spray the medication on the affected area no more than 3 to 4 times daily. Prior to application, it is essential to shake the container well to ensure proper mixing of the formulation.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

The product is contraindicated in the following situations:

Use is not recommended in conjunction with heating pads or devices, as this may lead to adverse effects. Additionally, the product should not be applied alongside ointments, creams, sprays, or liniments due to potential interactions that could compromise efficacy or safety. It is also contraindicated for use on wounds, damaged skin, or irritated skin, as this may exacerbate the condition or lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame. Users should avoid spraying the product in the eyes. The contents are under pressure; hence, the container should not be punctured or incinerated. It is crucial to store the product at temperatures not exceeding 120°F (48°C) to maintain its integrity and safety.

Before using this product, individuals should consult a healthcare professional if they have sensitive skin or are pregnant or breastfeeding.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Users are advised to discontinue use and consult a healthcare provider if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then reoccur within a few days, or if irritation develops.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame. The contents are under pressure, and users should not puncture or incinerate the container. Additionally, it is crucial to avoid storing the product at temperatures above 120°F (48°C).

The product should not be used in conjunction with heating pads or devices, ointments, creams, sprays, or liniments, nor should it be applied to wounds, damaged skin, or irritated skin. Patients with sensitive skin, as well as those who are pregnant or breastfeeding, should consult a doctor before use.

While using this product, patients should avoid contact with eyes or mucous membranes and refrain from tightly bandaging the area of application. If a patient's condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, they should stop use and consult a doctor. Additionally, if irritation develops, 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.

Drug Interactions

The use of this medication is contraindicated with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Co-administration with these products may lead to adverse effects or diminished therapeutic efficacy.

There are no specific laboratory test interactions reported for this medication. Therefore, routine monitoring of laboratory tests is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Fast Freeze Pain Relieving Continuous (menthol, unspecified form). 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 dosage is to spray on the affected area no more than 3 to 4 times daily.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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 before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are pregnant or breastfeeding. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

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 patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in conjunction with heating pads or devices, nor should it be applied alongside ointments, creams, sprays, or liniments.

Patients should be cautioned against using the product on wounds, damaged skin, or areas of irritated skin. They should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up only to reoccur within a few days. Additionally, patients should stop using the product and seek medical advice if they experience any irritation.

While using the product, patients must be reminded to avoid contact with their eyes and mucous membranes. They should also be advised not to bandage the area tightly after application. It is essential for patients with sensitive skin to consult a doctor before using the product. Furthermore, pregnant or breastfeeding patients should be encouraged to seek medical advice prior to use.

Storage and Handling

The product is supplied in a configuration that requires the cap to be replaced after each use to ensure proper sealing and integrity. It is essential to store the product in a cool, dry place to maintain its efficacy and stability. Care should be taken to avoid exposure to moisture and extreme temperatures during storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)