Icy Cool

Description

QC Quality Choice Pain Relieving Roll-On is a topical analgesic formulated with 5.5% natural menthol. This maximum strength product is designed to provide relief from aches and pains associated with strains, sprains, backaches, bruises, and arthritis. The roll-on dosage form contains 3 oz. (89 mL) of the product, which features an Icy Cool™ sensation enhanced with aloe. The product is comparable to BIOFREEZE® Pain Relieving Gel and is identified by NDC 63868-632-82.

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 recommended to wash the hands thoroughly with soap and water to prevent unintended exposure.

For children 12 years of age or younger, it is advised 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 lead to adverse effects. Additionally, the product should not be applied to wounds or areas of damaged, broken, or irritated skin to prevent further irritation or complications.

Warnings and Precautions

For external use only. This product should be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad, as these practices may exacerbate adverse effects.

Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes. Application to wounds or any damaged, broken, or irritated skin is contraindicated. Patients may experience a transient burning sensation upon application; however, this typically resolves within several days.

Patients are instructed to discontinue use and consult a healthcare provider if any of the following occur: worsening of the condition, presence of redness, development of irritation, or if symptoms persist beyond 7 days or recur shortly after resolution.

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

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 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 and then recur within a few days.

Additionally, the product is flammable; therefore, it should be kept away from fire or flame to ensure safety.

Drug Interactions

No drug interactions have been reported for the product. Additionally, there are no interactions identified between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 medication 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 absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective management of any complications that may arise from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

A transient burning sensation has been reported upon application of the product; however, this sensation typically resolves within several days. This event has been documented through voluntary reports and surveillance programs.

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 for healthcare providers 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 should also be advised to avoid contact with the eyes and mucous membranes, and not to apply the product to wounds or 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 to maintain safety. Additionally, it is crucial to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Additional Clinical Information

Patients should be advised that the product is for external use only. Clinicians should instruct patients to apply the topical formulation generously to the affected area, massaging it into the skin until fully absorbed. This application can be repeated as necessary, but should not exceed 3 to 4 times daily for adults and children over 12 years. For children under 12, consultation with a doctor is recommended prior to use.

Patients must follow specific precautions: the product should not be bandaged tightly or used in conjunction with a heating pad, and contact with eyes and mucous membranes should be avoided. It should not be applied to wounds or damaged skin. A transient burning sensation may occur upon application, typically resolving within several days. Patients are advised to 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 individuals should seek advice from a healthcare professional before use. Additionally, 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)