Icy Hot Kids Pain Relief Roll-on

Description

Icy Hot is a topical analgesic formulated for pediatric pain relief. It is presented in a roll-on dosage form, containing 1.5 fluid ounces (44.3 mL) of the product. The roll-on application allows for targeted delivery of the active ingredients to the affected area.

Uses and Indications

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

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

Dosage and Administration

For children aged 2 years and older, a thin layer of the medication should be applied 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 accidental transfer of the medication.

For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

The product is contraindicated for use on wounds or on irritated or damaged skin, as well as in conjunction with a heating pad.

Additionally, it is advised to avoid tight bandaging, contact with eyes and mucous membranes, exposure to local heat or direct sunlight, and application into skin folds.

If the condition worsens or symptoms persist for more than 7 days, if symptoms resolve and then recur within a few days, if redness or excessive skin irritation occurs, or if severe burning pain, swelling, or blistering develops at the application site, discontinue use and consult a healthcare professional.

Keep out of reach of children. In the event of ingestion, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product should not be applied to wounds or on irritated or damaged skin, nor should it be used in conjunction with a heating pad.

When using this product, it is imperative to adhere strictly to the directions provided. Bandaging should not be done tightly, and contact with the eyes and mucous membranes must be avoided. Users should refrain from exposing the treated area to local heat or direct sunlight. It is important to note that rare cases of serious burns have been reported with similar products. A transient burning sensation may occur upon application; however, this typically resolves within several days. Additionally, care should be taken to avoid applying the product into skin folds.

Users are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; redness or excessive skin irritation develops; or if severe burning pain, swelling, or blistering occurs at the site of application.

In the event of 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. It is contraindicated for application on wounds, irritated, or damaged skin, and should not be used in conjunction with a heating pad.

During use, patients are advised to follow the directions carefully, avoiding tight bandaging, contact with eyes and mucous membranes, and exposure of the treated area to local heat or direct sunlight. There have been rare reports of serious burns associated with products of this type. A transient burning sensation may occur upon application; however, this typically resolves within several days. Patients should also avoid applying the product into skin folds.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness or excessive skin irritation develops, 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

There are no specific drug interactions or laboratory test interactions reported for the product. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot Kids Pain Relief Roll-on (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older may apply a thin layer of the product to the affected area up to 3 to 4 times daily, ensuring to massage it until thoroughly absorbed into the skin. It is important for caregivers to wash their hands thoroughly with soap and water after each application.

For children under 2 years of age, it is advised to consult a doctor before use. Additionally, the application of the product should be conducted under adult supervision to ensure safety and proper usage.

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 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 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; 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

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 use of the compound in these contexts.

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 site of application.

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.

It is important for healthcare providers to inform patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also 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. Additionally, patients should be cautioned to stop use and consult a doctor if they experience severe burning pain, swelling, or blistering at the application site.

Patients should be reminded to use the product only as directed and to avoid bandaging the area tightly. They should also be advised to avoid contact with eyes and mucous membranes, and to refrain from exposing the treated area to local heat or direct sunlight. Healthcare providers should make patients aware 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 cautioned against applying the product into skin folds.

Storage and Handling

The product is supplied in a carton that contains important information for the user. It is essential to store the product at room temperature to maintain its integrity. After each use, the cap should be closed tightly to prevent contamination and ensure the product remains effective. The carton should be retained for reference to the critical information it provides.

Additional Clinical Information

The product is administered topically, with specific guidelines for children. For patients aged 2 years and older, a thin layer should be applied to the affected area no more than 3 to 4 times daily, ensuring thorough absorption into the skin, followed by thorough handwashing with soap and water. For children under 2 years of age, consultation with a doctor is advised.

Clinicians should counsel patients that the product should be applied under adult supervision. It is important to close the cap tightly after use and to retain the carton, as it contains essential information.

Drug Information (PDF)

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

View product document (PDF)