Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll on

Description

ICYHOT Original Nighttime Recovery is a topical analgesic formulated for pain relief. This product is designed for convenient application with a no-mess roll-on delivery system, allowing for targeted relief without the need for direct hand contact.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with various conditions, including arthritis, simple backache, strains, sprains, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and older, the recommended dosage is to apply a thin layer of the product to the affected area no more than 3 to 4 times daily. The application should be followed by gentle massage until the product is thoroughly absorbed into the skin. It is essential to wash hands thoroughly with soap and water after each use to prevent unintentional contact with other areas of the body or with other individuals.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing and administration guidance.

Contraindications

The product is contraindicated in the following situations:

Use is contraindicated on wounds or on irritated or damaged skin due to the potential for exacerbating the condition. Additionally, the application of the product in conjunction with a heating pad is contraindicated, as this may lead to increased risk of adverse effects.

Healthcare professionals should also advise patients to avoid bandaging tightly, contact with eyes and mucous membranes, exposure to local heat or direct sunlight, and application into skin folds to ensure safe use of the product.

Warnings and Precautions

For external use only. This product should not be applied to wounds or on irritated or damaged skin. It is contraindicated for use with heating pads.

When using this product, it is imperative to adhere strictly to the directions provided. Bandaging should not be done tightly, and contact with eyes and mucous membranes must be avoided. Additionally, the treated area should not be exposed to local heat or direct sunlight. There have been rare reports of serious burns associated with similar products. Users may experience a transient burning sensation upon application, which typically resolves within several days. Care should be taken to avoid application in skin folds.

Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve and then recur within a few days; there is the presence of redness or excessive skin irritation; or if severe burning pain, swelling, or blistering develops at the site of application.

This product must be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware that it is for external use only and should not be applied to wounds or on irritated or damaged skin. The product should not be used in conjunction with a heating pad.

When using this product, it is essential to follow the directions provided. Patients should avoid bandaging the area tightly and should take care to prevent contact with the eyes and mucous membranes. Additionally, exposure of the treated area to local heat or direct sunlight should be avoided. There have been rare reports of serious burns associated with products of this type. A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. Patients are advised to avoid applying the product into skin folds.

Patients should discontinue use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. They should also seek medical advice if symptoms clear up and then recur within a few days, if redness or excessive skin irritation occurs, or if they experience severe burning pain, swelling, or blistering at the application site.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The use of this medication is contraindicated with heating pads due to the potential for increased risk of adverse effects. It is advised that patients refrain from using heating pads while on this medication to avoid any complications.

There are no specific laboratory test interactions associated with this medication. Therefore, routine laboratory monitoring is not required in relation to this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is a thin layer to the affected area, not exceeding 3 to 4 times daily.

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, 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 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 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 limits the assessment of potential risks associated with the compound in these areas.

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. Users are advised to discontinue use and consult a healthcare professional if they experience severe burning pain, swelling, or blistering at the application site.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed not to use the product on wounds or on irritated or damaged skin, and to avoid using it in conjunction with a heating pad.

Patients should be informed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be advised to seek medical advice if symptoms resolve and then recur within a few days, if redness is present, or if excessive skin irritation occurs. It is important to inform patients to discontinue use and consult a healthcare professional if they experience severe burning pain, swelling, or blistering at the application site.

When using the product, patients should be reminded to follow the directions carefully and to avoid bandaging the area tightly. They should also be cautioned to avoid contact with eyes and mucous membranes, and to refrain from exposing the treated area to local heat or direct sunlight. Providers should inform patients that rare cases of serious burns have been reported with similar products, and that a transient burning sensation may occur upon application, typically subsiding within several days. Lastly, patients should be advised to avoid applying the product into skin folds.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, a thin layer should be applied to the affected area no more than 3 to 4 times daily, with thorough massage until fully absorbed into the skin. It is important for patients to wash their hands thoroughly with soap and water after each application. For children under 12 years of age, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Icy Hot Original Nighttime Recovery Pain Relief No Mess Roll on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)