Fast Freeze

Description

FAST FREEZE® is a pain-relieving topical spray designed for the relief of sore muscles, strains, sprains, and joint pain. This product features a continuous spray mechanism that delivers an invigorating cooling effect, primarily due to the inclusion of menthol.

The formulation is greaseless and stain-free, ensuring ease of application without residue. FAST FREEZE® incorporates natural ingredients such as Vitamin E, Aloe, and Ilex, contributing to its soothing properties. The product is available in a 4 oz (118 mL) container.

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 dispersion of the formulation.

For children under 2 years of age, it is advised to consult a physician before administering the medication.

Contraindications

The product is contraindicated for use in conjunction with heating pads or devices, as this may lead to excessive heat exposure. It should not be applied alongside ointments, creams, sprays, or liniments, due to the potential for adverse interactions. Application on wounds, damaged skin, or irritated skin is also contraindicated, as this may exacerbate the condition or lead to further irritation.

During use, it is essential to avoid contact with eyes or mucous membranes to prevent irritation or injury. Additionally, tight bandaging is not recommended, as it may restrict circulation and lead to complications.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame. Users must avoid spraying the product in the eyes. The contents are under pressure; therefore, it is imperative not to puncture or incinerate the container. Additionally, the product should not be stored at temperatures exceeding 120°F (48°C).

Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin or are pregnant or breastfeeding.

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

Patients are instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, if symptoms resolve and then reoccur within a few days, or if any irritation develops.

No specific laboratory tests are recommended for monitoring during the use of this product.

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 the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, patients are advised to stop use and consult a doctor. Development of irritation is also a reason to discontinue use and seek medical advice.

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 topical formulations such as 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 dosage is to spray 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 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 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 administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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; 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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

Patients should be advised 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 must 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 healthcare provider 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 they experience any irritation.

While using the product, patients should be reminded to avoid contact with their eyes or mucous membranes and to refrain from applying tight bandages. It is also essential to encourage patients to consult a healthcare provider before using the product if they have sensitive skin, or if they are pregnant or breastfeeding.

Storage and Handling

The product is supplied in a container that is under pressure. It is essential to store the product in a cool, dry place, ensuring that it is kept away from excessive heat or open flame. The storage temperature must not exceed 120°F (48°C). After each use, the cap should be securely replaced to maintain the integrity of the product. It is important to note that the container should not be punctured or incinerated, as this could pose safety risks.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the spray to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to consult a doctor prior to use if they have sensitive skin, are pregnant, or are breastfeeding. 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. Additionally, patients should stop use and consult a doctor if any irritation develops.

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)