Icy Freeze

Description

This formulation is a greaseless and stain-free topical spray that incorporates natural ingredients, including Aloe, Vitamin E, and Ilex. It features soothing menthol for a cooling effect and is designed with a vanishing scent for user comfort. The product is delivered in a 360° continuous spray format, ensuring even application. Each container holds 4 fluid ounces (120 mL).

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

For adults and children aged 2 years and older, the recommended dosage is to apply the solution to the affected area no more than 3 to 4 times daily. The solution should be rubbed into the skin until it is completely absorbed and no longer visible.

For children under 2 years of age, application must be supervised by an adult to ensure safety and proper use.

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated with heating pads or devices, as this may lead to excessive heat and potential skin damage. The application of creams, ointments, sprays, or liniments concurrently is also contraindicated due to the risk of adverse interactions. Additionally, the product should not be applied to wounds, damaged skin, or irritated skin, as this may exacerbate the condition.

During use, it is essential to avoid contact with eyes or mucous membranes to prevent irritation or injury. Bandaging should not be done tightly, as this may restrict circulation and lead to complications.

This product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

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

Healthcare professionals are advised to counsel patients to consult a physician 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 their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. Additionally, if any irritation develops, it is imperative to stop use 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 creams, ointments, sprays, or liniments. Additionally, it should not be applied to wounds, damaged skin, or irritated skin.

While using this product, patients should avoid contact with the eyes or mucous membranes and should not bandage the area tightly. If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days, it is advised to stop use and consult a doctor. Furthermore, if irritation develops, medical advice should be sought.

It is crucial to keep this product out of reach of children. 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 creams, ointments, sprays, or liniments. Co-administration with these products may lead to adverse effects or diminished therapeutic efficacy.

There are no specific drug or laboratory test interactions reported for this medication. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should have the application of this medication supervised by an adult. For children aged 2 years and older, the medication may 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 completely vanishes.

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 potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

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

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 the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product 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. Additionally, they should seek medical advice if any irritation develops while using the product.

When using this product, patients should be cautioned to avoid contact with the eyes or mucous membranes and to refrain from bandaging the area tightly.

Healthcare providers should also recommend that patients consult a doctor 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 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 stability and effectiveness.

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)