Cliniclean

Description

CliniClean is an antiseptic and antimicrobial solution containing 4% chlorhexidine gluconate. It is formulated as a foaming pump for use as a surgical hand scrub, health personnel hand wash, and general skin and wound cleanser. The product is dye-free and is available in a net content of 4 fluid ounces (118 mL). CliniClean is manufactured for HR Pharmaceuticals, Inc., located in York, PA 17402. The National Drug Code (NDC) for this product is 69464-901-05, and it is referenced as REF 90604. The product is identified by the code 4HRP04FMBTLLBLA and is documented under revision 4176 Rev 2, dated December 2023. 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 skin cleansing.

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

Dosage and Administration

Surgical hand scrub requires the healthcare professional to first wet their hands and forearms with water. They should then scrub for 3 minutes using 4 full pumps (6 grams) of the product along with a wet brush, 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 for 3 minutes using another 4 full pumps (6 grams) of the product, which should be rinsed under running water. Finally, the hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. The professional should dispense 4 full pumps (6 grams) of the product into cupped hands and wash vigorously for 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 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. Afterward, the area must be rinsed again thoroughly.

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, as it may lead to severe allergic reactions.

The product must not be applied in contact with the meninges due to the risk of serious complications.

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

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. Symptoms indicative of an allergic reaction may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of such symptoms, it is imperative to discontinue use immediately and seek medical assistance.

In cases where the product is ingested, emergency medical help should be sought without delay. Contacting a Poison Control Center is also recommended to ensure appropriate management.

Healthcare providers should advise patients to discontinue use and consult their physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and effective management of any reactions that may arise.

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant risk of severe allergic reactions associated with its use. Symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, patients should stop using the product and consult a healthcare professional if they experience any signs of irritation, sensitization, or an allergic reaction, as these may indicate a serious condition.

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 ensure that the product is kept out of reach of children to prevent accidental exposure.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. Due to potential risks to the fetus, chlorhexidine gluconate is contraindicated in pregnancy. Use during this period should be approached with caution, and it is recommended that pregnant patients consult a healthcare provider before use.

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 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 clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is prudent to implement standard supportive care measures. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center or seeking guidance from a medical toxicologist for further management recommendations.

As always, maintaining a comprehensive understanding of the patient's medical history and current medications is essential in managing any potential overdosage scenarios effectively.

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

Postmarketing experience has identified several adverse reactions associated with the use of chlorhexidine gluconate. Reports indicate the occurrence of allergic reactions, which may manifest as severe allergic responses including wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, there have been instances of irritation and sensitization reported in conjunction with the use of this agent.

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 essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

Patients should be cautioned against using the product in contact with the meninges or in the genital area. Providers must emphasize the importance of keeping 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 of contact with these sensitive areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

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°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

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)