Cliniclean

Description

No description information is available for the specified drug.

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 scrubs should begin with wetting the hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for 3 minutes, ensuring meticulous attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. An additional wash is required, using another 5 mL of the product for an additional 3 minutes, after which the hands should be rinsed under running water. It is essential to dry the hands and forearms thoroughly after the procedure.

For healthcare personnel handwashing, the process 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, the 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 the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this formulation should not use this product due to the risk of severe allergic reactions.

The product must not be applied in contact with the meninges, as this may lead to serious complications.

Additionally, use in the genital area is contraindicated to prevent potential adverse effects.

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. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact 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 avoid potential adverse effects.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

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

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

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration. It is advisable to consider the specific needs and health status of geriatric patients when determining the appropriateness of this treatment, ensuring that any risks are carefully weighed against the benefits.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate 4% solution during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions related to the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

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 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 absence of guidance necessitates careful clinical judgment and monitoring.

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, 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 and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions, such as anaphylaxis, as well as skin reactions, which encompass rash, pruritus, and urticaria. Additionally, reports of serious skin reactions, including chemical burns and skin irritation, have been received. There have also been cases of eye injury associated with contact of the product with the eyes. Furthermore, instances of ototoxicity have been documented when the solution was instilled in the middle ear through perforated eardrums.

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 product 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, if patients experience irritation, sensitization, or any signs of an allergic reaction, they should be informed that these symptoms may indicate a serious condition and should seek medical attention.

Storage and Handling

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

Additional Clinical Information

Patients should be advised to use the product with caution in premature infants or those under 2 months of age, as it may cause irritation or chemical burns. No further information is available regarding laboratory tests, abuse potential, route, method, frequency of administration, or postmarketing experience.

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.

View product document (PDF)