Icy Hot Dry

Description

ICYHOT ORIGINAL is a pain relief spray formulated as a dry spray for topical application. It is designed to provide instant relief from pain. The product is packaged in a net weight of 4 ounces (113 grams).

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

For adults and children over 12 years of age, the affected area should be sprayed with the desired amount of the product. The formulation is designed to dry quickly on its own and does not require rubbing in. Application may be repeated as necessary, but should not exceed 3 to 4 times daily. In the event that the product comes into contact with the hands, it is advised to wash the hands thoroughly with soap and water.

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

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated near heat or flame, or while smoking, due to the risk of ignition. Puncturing or incinerating the product is prohibited as it is under pressure, which may lead to hazardous situations. Storage at temperatures exceeding 120°F (49°C) is also contraindicated to prevent potential degradation or risk of explosion.

Contact with the eyes and mucous membranes must be avoided to prevent irritation or injury. Application to wounds or damaged, broken, or irritated skin is contraindicated to avoid adverse reactions. Additionally, the product should not be bandaged or subjected to local heat, such as heating pads or medicated patches, as this may alter its efficacy or safety. Exposure of the treated area to heat or direct sunlight is also contraindicated to prevent complications. Lastly, application into skin folds should be avoided to reduce the risk of irritation or improper absorption.

Warnings and Precautions

For external use only, this product must not come into contact with the eyes or mucous membranes. There have been rare reports of serious burns associated with similar products; therefore, caution is advised. It is imperative that the product is not applied to wounds, damaged, broken, or irritated skin. Additionally, the area of application should not be bandaged, subjected to local heat (such as heating pads), or treated with a medicated patch.

Upon application, a transient burning sensation may occur, which typically resolves within several days. However, if a severe burning sensation is experienced, the use of the product should be discontinued immediately. The treated area should also be protected from heat and direct sunlight, and care should be taken to avoid application in skin folds.

Healthcare professionals should advise patients to stop using the product and consult a physician if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or recurrence of symptoms after initial improvement. Signs of skin injury, such as pain, swelling, or blistering at the application site, warrant immediate medical attention.

This product is extremely flammable; therefore, it should not be used near heat sources, flames, or while smoking. Long-term storage should be avoided at temperatures exceeding 104°F (40°C), and the product should never be punctured or incinerated, as it is under pressure. Storage temperatures should not exceed 120°F (49°C).

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 should be aware that it is intended for external use only. While the product is generally well-tolerated, there have been rare reports of serious burns associated with similar products. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. Should a severe burning sensation arise, patients are advised to discontinue use immediately.

Patients are instructed to stop using the product and consult a healthcare professional if any of the following occur: worsening of the condition, presence of redness, development of irritation, persistence of symptoms beyond 7 days, or if symptoms clear up only to recur within a few days. Additionally, if patients experience signs of skin injury, such as pain, swelling, or blistering at the site of application, they should seek medical advice promptly.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot Dry (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 precaution is essential to ensure safety and appropriateness of treatment in this age group.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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; 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. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

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. 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 any of the following occur: the condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should seek medical attention if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is important to communicate that the product is extremely flammable. Patients should be cautioned against using it near heat or flame, or while smoking. Advise patients to avoid long-term storage above 104°F (40°C) and to refrain from puncturing or incinerating the container, as it is under pressure. Storage should not exceed temperatures of 120°F (49°C).

When using this product, patients should be instructed to use it only as directed and to read and follow all directions and warnings on the label. They should avoid contact with the eyes and mucous membranes, as rare cases of serious burns have been reported with similar products. Patients should not apply the product to wounds or damaged, broken, or irritated skin, nor should they bandage the area or apply local heat, such as heating pads or medicated patches.

Patients may experience a transient burning sensation upon application, which typically resolves within several days. However, if a severe burning sensation occurs, they should discontinue use immediately. It is also advisable to inform patients not to expose the treated area to heat or direct sunlight and to avoid applying the product into skin folds.

Storage and Handling

The product is classified as extremely flammable; therefore, it is imperative to avoid use near heat sources, flames, or while smoking. For optimal storage conditions, it is recommended to maintain the product at temperatures not exceeding 104°F (40°C). Additionally, storage should not occur at temperatures above 120°F (49°C) to ensure safety and efficacy.

The product is contained under pressure; hence, it is crucial to refrain from puncturing or incinerating the container. Proper handling and adherence to these storage guidelines are essential to prevent accidents and ensure the integrity of the product.

Additional Clinical Information

The product is administered topically, with the recommended application for adults and children over 12 years being to spray the affected area with the desired amount. This can be repeated as necessary, but should not exceed 3 to 4 times daily.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. Additionally, patients are advised to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)