Icy Cool

Description

QC Quality Choice Pain Relieving Gel is a maximum strength topical analgesic formulated with 5.5% natural menthol. This gel provides relief from aches and pains associated with strains, sprains, backaches, bruises, and arthritis. The product is enhanced with aloe for added soothing properties. It is packaged in a 4 oz. (118 ml) tube and is comparable to BIOFREEZE®. The National Drug Code (NDC) for this product is 63868-0633-18. The gel features an Icy Cool™ sensation upon application.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

Adults and children over 12 years of age should apply the medication generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day.

In the event that the medication comes into contact with the hands, it is advised to wash the hands thoroughly with soap and water to prevent unintended exposure.

For children 12 years of age or younger, it is recommended to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may exacerbate adverse effects. Contact with eyes and mucous membranes should be strictly avoided to prevent irritation or injury. Additionally, application to wounds or damaged, broken, or irritated skin is contraindicated due to the potential for increased sensitivity and adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients against tightly bandaging the area of application or using it in conjunction with a heating pad, as these practices may exacerbate adverse effects.

It is imperative to avoid contact with the eyes and mucous membranes. Additionally, the product should not be applied to wounds or any areas of damaged, broken, or irritated skin. Patients may experience a transient burning sensation upon application; however, this sensation typically resolves within several days.

Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist beyond 7 days or resolve only to recur within a few days.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product may experience a transient burning sensation upon application, which typically resolves within several days. It is important to note that this product is intended for external use only.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist for more than 7 days or resolve only to recur within a few days. These reactions should be monitored closely to ensure appropriate management and care.

Drug Interactions

No drug interactions have been identified for the specified medication. Additionally, there are no interactions noted between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

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

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional prior to use. This recommendation is essential to ensure safety and appropriateness of treatment in this age group.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

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

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 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens, if redness appears, or if irritation develops. Additionally, they should be informed to discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

It is important to emphasize that patients should use the product only as directed. They should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. Patients must also avoid contact with eyes and mucous membranes, and they should not apply the product to wounds or to damaged, broken, or irritated skin.

Patients may experience a transient burning sensation upon application, which is generally expected to subside within several days.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame. Freezing the product is not recommended, as it may compromise its integrity.

Additionally, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of accidental swallowing, immediate medical assistance should be sought, or contact with a Poison Control Center is advised. Proper handling and storage are crucial to maintaining the product's efficacy and safety.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 12 years to apply generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, but should not exceed 3 to 4 times daily.

Clinicians should counsel patients that the product is for external use only. Patients are advised to follow directions closely, avoiding tight bandaging or the use of heating pads, and to prevent contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin. A transient burning sensation may occur upon application, typically resolving within several days. Patients should discontinue use and consult a doctor if the condition worsens, if redness or irritation develops, or if symptoms persist beyond 7 days or recur shortly after resolution. Pregnant or breastfeeding patients should seek advice from a healthcare professional before use. The product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

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

View product document (PDF)