Blistex

Description

IVAREST® is an external analgesic formulated as a medicated cleansing foam specifically designed for the treatment of poison ivy, oak, and sumac exposure. The product is packaged in a 6 fluid ounce (177 mL) container and serves to prevent outbreaks when used shortly after exposure. Additionally, it provides soothing and comforting relief to the skin if symptoms have already developed. IVAREST® is characterized as a non-abrasive cooling cleanser, offering a gentle yet effective solution for managing the discomfort associated with these plant-related skin irritations. The National Drug Code (NDC) for this product is 10157-9012-2.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with exposure to Poison Ivy, Oak, and Sumac. It soothes and cools the skin, providing comfort to patients experiencing symptoms. Additionally, this drug may prevent outbreaks if applied shortly after exposure to the offending plants.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied directly to the affected area. It is important to gently rub the area to effectively remove urushiol, the toxic oil from the plant. Following application, the area must be rinsed thoroughly under running water.

The recommended frequency of application is not more than 3 to 4 times daily.

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

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, during use, contact with the eyes should be avoided.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of eye contact, immediate rinsing with water is recommended.

Patients should be instructed to discontinue use and consult a healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is imperative to keep this product out of reach of children to prevent accidental ingestion. In cases of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Blistex (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor before use. For children aged 2 years and older, the product may be applied to the affected area, with gentle rubbing to aid in the removal of urushiol, the toxic oil from plants. It is recommended to rinse the area under running water following application. The product should not be applied more than 3 to 4 times daily.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Blistex IVAREST Medicated Poison Ivy Cleansing Foam during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data when assessing the risks and benefits for pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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, healthcare professionals should advise patients or caregivers 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 a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, it is important to caution patients to avoid contact with the eyes while using this product to prevent irritation or injury.

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 protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with application to the affected area not exceeding 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)