Icy Freeze

Description

Icy Freeze is a therapeutic gel formulation designed for pain relief, specifically targeting conditions such as tendonitis, arthritis, sprains, and strains. The product is presented in a 4 fluid ounce (120 mL) gel pump container. It features a greaseless and stain-free composition, incorporating natural ingredients such as aloe, vitamin E, and Ilex. The formulation includes soothing menthol, providing a cooling effect upon application, and is characterized by a vanishing scent.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions, including tendonitis, strains, sprains, sore muscles, joint discomfort, and arthritis.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. It is important to rub the solution into the skin until it is completely absorbed and no longer visible. Care should be taken to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

Contraindications

The product is contraindicated in the following situations:

• Use with heating pads or devices is prohibited due to the potential for increased risk of adverse effects.

• Concurrent use with creams, ointments, sprays, or liniments is not recommended, as this may lead to unpredictable interactions or enhanced side effects.

• Application on wounds, damaged skin, or irritated skin is contraindicated to prevent exacerbation of the condition and to ensure proper healing.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from excessive heat or open flame.

General precautions must be observed to ensure safe use. The product should not be used in conjunction with heating pads or devices, nor should it be applied alongside creams, ointments, sprays, or liniments. It is contraindicated for use on wounds, damaged skin, or irritated skin. Healthcare professionals should advise patients to consult a doctor prior to use if they have sensitive skin, or if they are pregnant or breastfeeding.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should be instructed to discontinue use and contact their healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. Additionally, any development of irritation should prompt a consultation with a healthcare professional.

Side Effects

Patients should discontinue use and consult a healthcare professional 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, if irritation develops, patients are advised to seek medical advice.

Before using this product, patients should inform their healthcare provider if they have sensitive skin or if they are pregnant or breastfeeding. It is important to note that this product is for external use only and is flammable; therefore, it should be kept away from excessive heat or open flame.

Patients should not use this product in conjunction with heating pads or devices, nor should it be applied with creams, ointments, sprays, or liniments. The product should not be applied to wounds, damaged skin, or irritated skin. While using this product, patients should avoid contact with eyes or mucous membranes and should not bandage the area tightly.

This product should be kept out of reach of children. In the event of accidental ingestion, medical help should be sought immediately, 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 creams, ointments, sprays, or liniments. Co-administration with these products may lead to adverse effects or diminished therapeutic efficacy.

No specific drug or laboratory test interactions have been identified. Therefore, routine monitoring for interactions with other medications or laboratory tests is not necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Freeze (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily, ensuring to rub the solution into the skin until it vanishes. For children under 2 years of age, application should be conducted under adult supervision to ensure safety and proper use.

Geriatric Use

Elderly patients may not have specific information regarding the use of ICY FREEZE menthol gel, as the drug insert does not provide data on geriatric use. Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to topical agents in this population.

Due to the lack of clinical findings specific to elderly patients, it is advisable to monitor for any adverse effects closely and to consider individual patient factors when determining the appropriateness of this treatment. Additionally, healthcare providers should be vigilant in assessing the need for dosage adjustments based on the overall health status and concurrent medications of geriatric patients.

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

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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management.

Prompt action is crucial in mitigating 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 any clinical manifestations that arise.

In summary, the key steps in managing an overdosage situation include securing the product from children, seeking immediate medical help, and contacting a Poison Control Center for guidance on further actions.

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 keep the medication out of reach of children and to seek medical help or contact a Poison Control Center immediately if the medication is swallowed. Patients should be informed to avoid contact with eyes or mucous membranes to prevent irritation.

It is important to instruct patients not to bandage the area tightly and to refrain from using the medication in conjunction with heating pads or devices. Additionally, patients should be cautioned against using the medication alongside creams, ointments, sprays, or liniments, as this may lead to adverse effects.

Patients should be advised not to apply the medication on wounds, damaged skin, or irritated skin. They should be instructed to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. Furthermore, patients should be informed to discontinue use and seek medical advice if any irritation develops.

Healthcare providers should encourage patients to consult a doctor before using the medication if they have sensitive skin, or if they are pregnant or breastfeeding, to ensure safety and appropriateness of 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.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)