Fast Freeze

Description

FAST FREEZE® is a pain-relieving roll-on formulation designed to alleviate discomfort associated with sore muscles, strains, sprains, and joint pain. The product features invigorating cooling menthol, providing a soothing effect upon application. It is greaseless and stain-free, ensuring ease of use without residue. The formulation incorporates natural ingredients, including Vitamin E, Aloe, and Ilex, contributing to its efficacy and skin-friendly properties. Each container holds 3 oz (89 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

Adults and children aged 2 years and older should apply the product by rolling it on the affected area. The application should not exceed 3 to 4 times daily. Prior to use, it is essential to shake the container well to ensure proper mixing of the formulation.

Contraindications

The product is contraindicated for use in the following situations:

Use of this product with heating pads or devices is prohibited due to the potential for increased risk of burns or skin irritation. Additionally, it should not be applied in conjunction with ointments, creams, sprays, or liniments, as this may alter the efficacy of the product or lead to adverse reactions.

Application on wounds, damaged skin, or irritated skin is contraindicated to prevent further injury or complications.

While using this product, it is essential to avoid contact with eyes or mucous membranes to prevent irritation or injury. Furthermore, tight bandaging is not recommended, as it may restrict circulation and lead to additional complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from excessive heat or open flame to prevent fire hazards.

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or are pregnant or breastfeeding. These considerations are crucial to ensure the safety and appropriateness of the product for individual patients.

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

Patients should be 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, symptoms resolve and then reoccur within a few days, or if any irritation develops. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

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 contraindicated for use with heating pads or devices, as well as with ointments, creams, sprays, or liniments. Additionally, it should not be applied to wounds, damaged skin, or irritated skin.

Before using this product, patients are advised to consult a healthcare professional if they have sensitive skin or are pregnant or breastfeeding. While using the product, it is crucial to avoid contact with the eyes or mucous membranes and to refrain from tightly bandaging the area of application.

Patients should discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. Development of irritation is also a reason to stop use and consult a healthcare provider.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

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 (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 roll on the affected area no more than 3 to 4 times daily.

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 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 seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are 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

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 question.

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 irritated skin. They should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 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 any irritation develops.

While using the product, patients must be reminded to avoid contact with their eyes or 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 ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place to maintain its efficacy. After each use, the cap must be securely replaced to prevent contamination and preserve the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)