Icy Hot Medicated No Mess Applicator

Description

ICY HOT® ORIGINAL NO-MESS ROLL ON PAIN RELIEF contains 16% menthol as its active ingredient. This formulation is provided in a dosage form of a roll-on solution, with a total volume of 2.5 fluid ounces (73 mL). The product is designed for topical application to relieve pain.

Uses and Indications

This drug is indicated for the temporary relief of minor pain 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

Adults and children 12 years of age and older are instructed to apply a thin layer of the medication to the affected area, not exceeding 3 to 4 applications per day. 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 recommended to consult a physician for appropriate dosing and administration guidance.

Contraindications

The product is contraindicated for use on wounds or on irritated or damaged skin due to the potential for exacerbating the condition. It should not be used in conjunction with a heating pad, as this may increase the risk of adverse effects.

Additionally, the product should not be applied tightly bandaged, nor should it come into contact with the eyes or mucous membranes. Exposure to local heat or direct sunlight in the treated area must be avoided, as well as application in skin folds, to prevent complications.

If the condition worsens or symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued, and a healthcare professional should be consulted. Immediate medical attention is required if redness, excessive skin irritation, severe burning pain, swelling, or blistering occurs at the application site.

This product must be kept 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 is flammable; therefore, it must be kept away from heat and open flame.

The product should not be applied to wounds or on irritated or damaged skin. Additionally, it should not be used in conjunction with a heating pad.

When using this product, it is imperative to follow 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, but this typically resolves within several days. 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.

This product should 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 should be made without delay.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Warnings indicate that the product is for external use only and is flammable; therefore, it should be kept away from heat and open flames. It is contraindicated for use on wounds or on irritated or damaged skin, and should not be used in conjunction with a heating pad.

During application, patients are advised to use the product only as directed, avoiding tight bandaging, contact with eyes and mucous membranes, and exposure to local heat or direct sunlight. Rare cases of serious burns have been reported with similar products, highlighting the importance of adhering to these guidelines. A transient burning sensation may occur upon application, which 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 or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, or if redness or excessive skin irritation occurs, medical advice should be sought. Severe burning pain, swelling, or blistering at the application site also necessitates immediate consultation with a healthcare provider.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center without delay.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot Medicated No Mess Applicator (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. This precaution is essential to ensure safety and appropriateness of treatment in this age group.

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, 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 healthcare 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 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 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. Continuous monitoring and evaluation are vital to ensure patient safety and effective recovery.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product on wounds or on irritated or damaged skin. Additionally, they should be cautioned against using the product in conjunction with a heating pad. It is important to instruct patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. They should also be advised to seek medical advice if symptoms resolve and then recur within a few days.

Healthcare providers should emphasize that patients must stop using the product and consult a doctor if they experience redness, excessive skin irritation, 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.

It is crucial to inform patients to avoid contact with eyes and mucous membranes, and to refrain from exposing the treated area to local heat or direct sunlight. Providers should make patients aware that rare cases of serious burns have been reported with similar products. A transient burning sensation may occur upon application, but this typically resolves within several days. Patients should also be advised to avoid 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 keep the carton intact for reference. After each use, the cap must be closed tightly to ensure the integrity of the product.

For optimal storage, the product should be kept away from fire or flame to prevent any hazards. Proper handling and storage conditions are crucial to maintain the product's efficacy and safety.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years, a thin layer should be applied to the affected area and massaged into the skin until fully absorbed, with a maximum frequency of 3 to 4 times daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. 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 Medicated No Mess Applicator, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)