Fast Freeze Pain Relieving

Description

FAST FREEZE® is a pain-relieving roll-on formulation designed to alleviate discomfort associated with sore muscles, strains, sprains, and joint pain. Each container holds 3 oz (89 mL) of the product, which features an invigorating, cooling menthol for enhanced relief. The formulation is greaseless and stain-free, ensuring ease of application without residue. Key natural ingredients include Vitamin E, Aloe, and Ilex, contributing to the product's soothing properties.

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 application is to roll the product onto 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 appropriateness of treatment.

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 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 essential 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 contact their healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days. Additionally, if any irritation develops, it is crucial to stop using the product and seek medical advice.

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. During use, it is crucial to avoid contact with the eyes or mucous membranes, and patients should 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 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 interactions identified with laboratory tests associated with this medication. Therefore, routine monitoring of laboratory parameters is not required in the context of drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Fast Freeze Pain Relieving (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 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 known. 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 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 dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 instruct patients to avoid contact with the eyes and mucous membranes to prevent irritation or injury.

Healthcare providers should emphasize that patients must not bandage the area tightly after application. Additionally, patients should be informed that the product should not be used in conjunction with heating pads or devices, nor should it be combined with 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 7 days, or if symptoms clear up only to reoccur within a few days. Furthermore, patients should be advised to stop using the product and seek medical advice if any irritation develops.

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.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)