Icy Hot

Description

ICY HOT® MEDICATED ROLL is a pain-relieving ointment formulated with 7.5% menthol as the active ingredient. This product is presented on a breathable, flexible fabric, measuring 2 inches in width and 60 inches in length (5 cm x 150 cm). The roll can be easily torn or cut to any desired length, providing versatility in application. It is designed to last up to 8 hours, offering extended relief. The medium strength formulation ensures comfort and flexibility, allowing the product to stay securely in place during use.

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 tear or cut the roll to the desired size. The backing should be carefully removed from one end of the strip, which is then placed on the affected area. After positioning, the remaining backing must be removed, and the strip should be pressed firmly into place. The Icy Hot Medicated Roll may be worn for up to 8 hours. This application can be repeated as necessary, but should not exceed 3 to 4 times daily.

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

Contraindications

The product is contraindicated in the following situations:

Tight bandaging or the use of heating pads in conjunction with the product is not recommended, as this may lead to increased risk of injury or adverse effects. Overwrapping or wrapping strips over themselves is contraindicated to prevent compromised circulation. The product should not be wrapped around the neck due to the risk of airway obstruction.

Application over large areas of the body or in strips longer than 6 inches is contraindicated to avoid systemic absorption and potential toxicity. Contact with eyes and mucous membranes must be avoided to prevent irritation or injury. Additionally, the product should not be applied to wounds or to damaged, broken, or irritated skin to prevent exacerbation of the condition or further injury.

Warnings and Precautions

For external use only. This product must be utilized strictly as directed to ensure safety and efficacy. It is imperative to avoid bandaging tightly or using the product in conjunction with a heating pad. Overwrapping or wrapping strips over themselves is contraindicated, as is wrapping around the neck. Application should be limited to small areas; do not apply over large areas of the body or use strips longer than 6 inches. Care should be taken to avoid contact with the eyes and mucous membranes, and the product must not be applied to wounds or any damaged, broken, or irritated skin.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens, redness is observed, irritation develops, or symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

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 should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid certain practices that may lead to adverse reactions. Specifically, patients should not bandage tightly, use a heating pad in conjunction with the product, overwrap, or wrap strips over themselves. Additionally, the product should not be applied around the neck, over large areas of the body, or in strips longer than 6 inches. Care should be taken to avoid contact with the eyes and mucous membranes, and it should not be applied to wounds or damaged, broken, or irritated skin.

In the event that the condition worsens, redness develops, irritation occurs, or symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to stop use and consult a healthcare professional.

Furthermore, if the product is swallowed, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot (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. It is important for caregivers to seek medical advice to ensure the safety and appropriateness of treatment for 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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 no specific data available 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 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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. 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 appears, irritation develops, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

When using this product, it is essential to use it only as directed. Patients should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. They should not overwrap or allow strips to wrap over themselves, nor should they wrap the product around the neck. Additionally, patients should avoid applying the product over large areas of the body or using strips longer than 6 inches. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or to damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in resealable pouches, which should be securely resealed after each use to maintain product integrity. It is recommended to store the product in a cool, dry place to ensure optimal quality and effectiveness.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children over 12 years. Patients should tear or cut the roll to the desired size, carefully remove the backing from one end, and place it on the affected area. After pressing it into place, the remaining backing should be removed. The Icy Hot Medicated Roll can be worn for up to 8 hours and may be repeated as necessary, but not more than 3 to 4 times daily. For children 12 years or younger, consultation with a doctor is advised.

Clinicians should counsel patients that the product is for external use only and must be used as directed. It should not be bandaged tightly, used with a heating pad, or wrapped around the neck. Patients should avoid applying it over large areas, in strips longer than 6 inches, or on wounds and damaged skin. Contact with eyes and mucous membranes should be avoided. Patients are advised to discontinue use and consult a doctor if the condition worsens, redness or irritation develops, symptoms persist for more than 7 days, or if symptoms recur shortly after resolution. Pregnant or breastfeeding patients should seek professional advice before use, and the product should be kept out of reach of children. In case of ingestion, medical help or contact with a Poison Control Center is recommended.

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)