Icy Hot Dry

Description

No description information is available for the specified drug.

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 without the need for 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 important to wash the hands thoroughly with soap and water.

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

• Contact with the eyes and mucous membranes should be avoided to prevent irritation or injury.

• Application to wounds or damaged, broken, or irritated skin is contraindicated to avoid exacerbating the condition.

• Bandaging or applying local heat (such as heating pads) or a medicated patch to the area of use is not recommended, as it may lead to adverse effects.

• Exposure of the treated area to heat or direct sunlight should be avoided to prevent potential complications.

• Application into skin folds is contraindicated to reduce the risk of irritation or adverse reactions.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to read and adhere to all instructions and warnings provided on the label. It is imperative to prevent contact with the eyes and mucous membranes, as such exposure may lead to adverse effects.

Serious burns, although rare, have been reported with the use of similar products. Therefore, it is crucial to avoid application on wounds, damaged, broken, or irritated skin. Additionally, patients should be instructed not to bandage the treated area or apply local heat, such as heating pads or medicated patches, as this may exacerbate the risk of injury. A transient burning sensation may occur upon application; however, this typically resolves within several days. Should a severe burning sensation arise, patients must discontinue use immediately.

Patients should be cautioned against exposing the treated area to heat or direct sunlight and advised to avoid application in skin folds to minimize the risk of irritation.

Healthcare professionals should instruct patients to stop use 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 consultation.

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 must not be punctured or incinerated, as it is under pressure. Storage at temperatures above 120°F (49°C) is also contraindicated.

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 for external use only. Rare cases of serious burns have been reported with similar products, highlighting the importance of caution during application. 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: 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 advice if they experience signs of skin injury, such as pain, swelling, or blistering at the site of application.

It is important to note that the product is extremely flammable. Patients should avoid using it near heat or flame, or while smoking. Long-term storage above 104°F (40°C) should be avoided, and the product should not be punctured or incinerated, as it is under pressure. Storage at temperatures exceeding 120°F (49°C) is also not recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 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

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be prudent 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 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

Rare cases of serious burns have been reported in postmarketing experience with products of this type. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if redness is observed, or if irritation develops. It is important to inform patients that they should stop using the product and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

Patients should also be made aware that they need to stop use and consult a healthcare professional if they experience any signs of skin injury, such as pain, swelling, or blistering at the application site. Emphasize the importance of using the product only as directed and encourage patients to read and follow all directions and warnings on the label.

Healthcare providers should caution patients against allowing the product to come into contact with the eyes and mucous membranes. It is essential to inform patients that rare cases of serious burns have been reported with similar products. Advise patients not to apply the product to wounds or to damaged, broken, or irritated skin. Additionally, patients should be instructed not to bandage the area or apply local heat, such as heating pads or medicated patches, to the treated area.

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 important to advise patients to avoid exposing the treated area to heat or direct sunlight and to refrain from applying the product into skin folds.

Storage and Handling

The product is supplied in a pressurized container that must be handled with care. It is essential to avoid long-term storage at temperatures exceeding 104°F (40°C) and to ensure that the product is not stored at temperatures above 120°F (49°C).

Due to the pressurized nature of the contents, the container should not be punctured or incinerated. Additionally, the product is extremely flammable; therefore, it should not be used near heat sources, open flames, or while smoking. Proper storage and handling are crucial to maintain safety and efficacy.

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, it is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

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)