Cliniclean

Description

CliniClean is an antiseptic and antimicrobial solution containing 4% chlorhexidine gluconate. It is formulated for use as a surgical hand scrub, healthcare personnel hand wash, and general skin and wound cleanser. This product is dye-free, ensuring a clear formulation suitable for various applications in healthcare settings. CliniClean is manufactured for HR Pharmaceuticals, Inc., located in York, PA 17402. Further information can be found at cliniclean.com.

Uses and Indications

This drug is indicated for use as a surgical hand scrub, significantly reducing the number of microorganisms on the hands and forearms prior to surgical procedures or patient care. It is also indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is suitable for skin wound and general cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. Approximately 5 mL of the product should be applied using a wet brush, ensuring a thorough scrub for 3 minutes, with particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, hands and forearms must be rinsed thoroughly. An additional wash with 5 mL of the product is then required, lasting for another 3 minutes, after which the hands should be rinsed under running water. It is essential to dry the hands and forearms thoroughly after this process.

For healthcare personnel handwashing, the procedure begins with wetting the hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for about 15 seconds. After washing, hands must be rinsed and dried thoroughly.

In the case of skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required once again to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, the product should not be applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

Warnings and Precautions

For external use only. This product carries a significant risk of causing severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions must be observed to ensure safe application. Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled into the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider to prevent adverse effects.

In cases of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition requiring further evaluation.

Side Effects

This product may cause a severe allergic reaction in some patients. Symptoms of such reactions can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to stop use immediately and seek medical assistance.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, the product should not be applied in contact with the meninges or in the genital area.

When using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is advised to rinse thoroughly with water. Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product, and repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare provider.

Patients are advised to stop use and consult a doctor if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. In cases of accidental ingestion, immediate medical help should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading to staining. To mitigate this interaction, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleaning purposes.

Packaging & NDC

Below are the non-prescription pack sizes of Cliniclean (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should use this product with caution due to the potential for irritation or chemical burns. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 are no specific statements regarding the use of CliniClean (chlorhexidine gluconate 4% solution) during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide sufficient information to assess the potential risks or benefits of this medication in pregnant patients. Healthcare professionals should consider the lack of established safety data when prescribing CliniClean to women of childbearing potential and weigh the potential risks against the clinical need for treatment.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

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 patients 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 of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. In cases where the specific substance is known, appropriate antidotes or treatments should be administered as per established protocols.

It is essential for healthcare providers to remain vigilant and act swiftly to mitigate the potential risks associated with 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 use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports have included allergic reactions, which encompass severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been documented, which may suggest the potential for serious conditions. These events were reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is crucial to inform patients to keep the solution away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums.

In the event that the solution comes into contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. Providers should also counsel patients that wounds involving more than the superficial layers of the skin should not be treated routinely with this product.

Patients should be made aware that repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider. Additionally, they should be informed to monitor for any signs of irritation, sensitization, or allergic reactions, as these may indicate a serious condition requiring medical attention.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25 ºC (68-77 ºF). Care must be taken to avoid exposure to excessive heat, as temperatures above 40 ºC (104 ºF) can compromise the integrity of the product. Proper storage conditions are essential to maintain the quality and efficacy of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. In the event of an allergic reaction, patients are instructed to discontinue use immediately and seek medical assistance. If the product is ingested, it is crucial to obtain medical help or contact a Poison Control Center without delay.

Drug Information (PDF)

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

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