Icy Hot Vanishing Scent

Description

Menthol 2.5% is the active ingredient in this pain-relieving gel, marketed under the brand name IcyHot®. The formulation is designed to provide a cooling sensation upon application, contributing to its efficacy in alleviating pain. The product is presented in a net weight of 2.5 oz (70.8 g) and features a vanishing scent, enhancing user experience while minimizing lingering odors.

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

Adults and children 12 years of age and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. A sponge-top applicator should be utilized to massage the medication into the skin until it is thoroughly absorbed. It is essential to wash hands thoroughly with soap and water after each application 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 before use.

Contraindications

Use of this product is contraindicated in the following situations:

• Tight bandaging should be avoided to prevent compromised circulation.

• Contact with eyes and mucous membranes must be avoided to prevent irritation or injury.

• Exposure of the treated area to local heat or direct sunlight is contraindicated due to the risk of adverse reactions.

• Application into skin folds is not recommended to minimize the potential for irritation or inadequate absorption.

Warnings and Precautions

For external use only. This product should not be applied to wounds or on irritated or damaged skin. Additionally, it must not be used in conjunction with a heating pad.

When utilizing 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. Care should be taken to avoid application in 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 accidental 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 of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to wounds, irritated, or damaged skin. Additionally, it should not be used in conjunction with a heating pad.

When using this product, it is crucial to follow the directions provided. Patients should avoid bandaging the area tightly and should refrain from contact with eyes and mucous membranes. Exposure to local heat or direct sunlight should also 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 against applying the product into skin folds.

Patients should discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. They should also seek medical advice if symptoms resolve 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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Icy Hot Vanishing Scent (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 before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals are advised to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by medical personnel 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 critical to ensure patient safety and effective management of any complications that may arise 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 limits the assessment of potential risks associated with the compound in these areas.

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. The nature of these reports underscores the importance of ongoing monitoring and evaluation of product safety in the postmarketing setting.

Patient Counseling

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

When using the product, patients should be instructed to follow the directions carefully and avoid bandaging the area tightly. They should also be cautioned to avoid contact with the eyes and mucous membranes, as well as to refrain from exposing the treated area to local heat or direct sunlight.

Patients should be made aware that rare cases of serious burns have been reported with similar products. They may experience a transient burning sensation upon application, which typically subsides within a few days. Lastly, it is advisable to avoid applying the product into skin folds to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a carton that contains essential information for proper use and handling. It is important to retain the carton 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 in a controlled environment, away from extreme temperatures and direct sunlight. Specific temperature ranges and additional handling requirements should be adhered to as per the manufacturer's guidelines to maintain product efficacy.

Additional Clinical Information

The product is administered topically, with recommendations for adults and children over 12 years to apply generously to the affected area, repeating as necessary but not exceeding four applications daily. For children aged 12 years or younger, consultation with a healthcare provider is advised prior to use.

Clinicians should counsel patients to seek advice from a healthcare professional if they are pregnant or breastfeeding. It is also important to keep the product out of reach of children; in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)