Icy Hot

Description

ICYHOT® Pain Relieving Stick is formulated for extra strength pain relief. The product is presented in a stick dosage form, with a net weight of 1.75 ounces (49 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, a thin layer of the medication should be applied to the affected area. The application should be followed by 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 four applications within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated in the following situations:

Application is prohibited on wounds or on irritated, damaged, or broken skin due to the risk of exacerbating the condition. The use of heating pads concurrently is contraindicated, as it may increase the risk of skin irritation or burns. Additionally, the simultaneous application of other topical analgesics is not recommended, as it may lead to increased systemic absorption and potential adverse effects.

Furthermore, exposure of the treated area to heat or direct sunlight should be avoided to prevent skin irritation and other complications.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to refer to the inside label for complete drug facts.

Allergy Alert: Patients with a history of allergic reactions to aspirin or salicylates are advised to consult a physician prior to use.

General Precautions: It is imperative that the product is used strictly as directed. Patients should read and adhere to all instructions and warnings provided on the label. Care should be taken to avoid contact with the eyes and mucous membranes. There have been rare reports of serious burns associated with similar products; therefore, caution is warranted. The product should not be applied to wounds or to skin that is damaged, broken, or irritated.

Additionally, patients should be instructed not to bandage the area tightly or apply local heat, such as heating pads or medicated patches, to the site of application. A transient burning sensation may occur upon application, which typically resolves within several days. However, if a severe burning sensation is experienced, the patient should discontinue use immediately. It is also advised to avoid exposing the treated area to heat or direct sunlight.

Emergency Medical Help: In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Discontinuation of Use: Patients should be advised to stop using the product and consult a healthcare provider if any of the following occur: the condition worsens, redness is observed, irritation develops, or symptoms persist for more than 7 days or resolve only to recur within a few days.

Side Effects

Patients using this product should be aware of potential adverse reactions. Rare cases of serious burns have been reported with products of this type. A transient burning sensation may occur upon application; however, this sensation generally resolves within several days. If patients experience a severe burning sensation, they are advised to discontinue use immediately.

Patients should also be instructed to stop use and consult a doctor if their condition worsens, if redness is present, if irritation develops, or if symptoms persist for more than 7 days or resolve only to recur within a few days. Additionally, individuals who are prone to allergic reactions from aspirin or salicylates should consult a doctor before using this product.

Drug Interactions

Concurrent use of this medication with other topical analgesics is contraindicated. The combination may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and efficacy of treatment. Monitoring for signs of irritation or systemic effects is recommended if there is any uncertainty regarding the use of concomitant topical therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot (menthol and methyl salicylate). 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. For adolescents and children over 12 years, the recommended application involves applying a thin layer to the affected area, followed by gentle massage until the product is fully absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications per day.

Geriatric Use

Elderly patients may use Icy Hot Pain Relieving Stick, Balm, or Cream; however, the drug insert does not provide specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when recommending this product to geriatric patients, considering the absence of data on its use in this demographic. Monitoring for any adverse effects or unusual reactions is advisable, given the lack of established safety profiles in elderly individuals.

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 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 advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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. 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. Individuals with a known sensitivity to aspirin or salicylates should seek medical advice before using the product. Upon application, a transient burning sensation may be experienced, which typically resolves within several days. In cases where a severe burning sensation occurs, it is recommended to discontinue use immediately. Additionally, it is important to avoid exposing the treated area to heat or direct sunlight.

No specific nonclinical toxicology data or animal pharmacology and toxicology data are provided in the insert.

Postmarketing Experience

Rare cases of serious burns have been reported with products of this type. Additionally, a transient burning sensation may occur upon application, typically resolving within several days. In instances of severe burning sensation, it is advised to discontinue use immediately. Users should also be vigilant for signs of skin injury, including pain, swelling, or blistering at the site of application.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential for patients to use the product only as directed and to read and follow all directions and warnings provided on the label.

Patients should be informed to avoid contact with eyes and mucous membranes, as this may lead to irritation. Providers should also discuss the potential for rare cases of serious burns associated with products of this type, emphasizing the importance of not applying the product to wounds, damaged, broken, or irritated skin.

Additionally, patients should be cautioned against tightly bandaging the area of application or applying local heat, such as heating pads or medicated patches, to the treated area. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. If patients experience a severe burning sensation, they should be instructed to discontinue use immediately.

Finally, healthcare providers should remind patients to avoid exposing the treated area to heat or direct sunlight to prevent adverse effects.

Storage and Handling

The product is supplied in a configuration that requires careful handling to maintain its integrity. It is essential to close the cap tightly after each use to prevent contamination and ensure the product remains effective.

For optimal storage, the product should be kept in a cool, dry place, away from heat sources and direct sunlight. Exposure to elevated temperatures or sunlight may compromise the product's efficacy. Proper storage conditions are crucial for preserving the quality and safety of the product.

Additional Clinical Information

Patients aged 12 years and older are instructed to apply a thin layer of the product to the affected area, massaging it into the skin until fully absorbed. This application may be repeated as necessary, but should not exceed four times daily. For children under 12 years, consultation with a doctor is recommended prior to use.

Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional before using the product. It is important to keep the product out of reach of children, and in the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)