Cliniclean

Description

CliniClean is an antiseptic and antimicrobial solution containing 4% chlorhexidine gluconate. It is available in two formulations: a 4 fl oz (118 mL) bottle and a box containing 50 single-use 0.5 fl oz (15 mL) packettes. Both formulations are non-sterile and dye-free, designed for patient pre-operative preparation, surgical hand scrubbing, healthcare personnel hand washing, and general skin and wound cleansing. Each product is intended for single use. CliniClean is manufactured by HR Pharmaceuticals, Inc., located in York, PA 17402. The product is identified by NDC 69494-901-04 for the 4 fl oz bottle and NDC 69494-901-15 for the 50 packettes. The most recent revisions of the product labeling are Rev 4170-0 (02/2023) for the bottle and Rev 4175-0 (02/2023) for the packettes. 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 surgery 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 utilized for patient preoperative skin preparation, ensuring the preparation of the patient's skin prior to surgical procedures. Furthermore, it is indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the operator to first wet their hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention is given to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following this, the hands and forearms must be rinsed thoroughly. The scrubbing process should be repeated for an additional 3 minutes using another 5 mL of the product, followed by rinsing under running water. It is essential to dry the hands and forearms thoroughly after completion.

For healthcare personnel handwashing, the hands should be wetted with water before dispensing approximately 5 mL of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, followed by thorough rinsing and drying of the hands.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes, after which it should be dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with another sterile towel.

For skin wound and general skin cleansing, the area intended for cleaning should be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required once again to ensure complete cleansing.

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.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Additionally, the product should not be applied in the genital area to avoid 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 an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Additionally, healthcare providers should advise patients to stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

In cases of accidental ingestion, it is crucial to obtain medical help or contact a Poison Control Center without delay to ensure appropriate management of the situation.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Severe allergic reactions have been reported, which may manifest as symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Patients should be advised to discontinue use and seek medical attention immediately if any of these symptoms occur, as they may indicate a serious condition.

In clinical settings, it is crucial to avoid use in patients with known allergies to chlorhexidine gluconate or any other ingredients in the product. Additionally, the product should not be applied in contact with the meninges or in the genital area.

When using this product, care must be taken to prevent contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these areas, it is essential to rinse thoroughly with water. Furthermore, 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.

In the event of ingestion, patients should seek medical help or contact a Poison Control Center immediately.

Patients should also be monitored for signs of irritation, sensitization, or allergic reactions during use, as these may indicate the development of 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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to closely monitor these patients to mitigate potential risks associated with their use.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature 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. It is essential to assess the individual patient's condition and adjust the treatment plan accordingly to ensure safety and efficacy.

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 lack of data 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, 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 overdosage incidents to facilitate effective treatment and minimize risks.

Nonclinical Toxicology

No teratogenic effects have been identified in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable reactions include allergic responses, such as anaphylaxis, as well as various skin reactions, including rash, pruritus, and dermatitis. Additionally, reports of serious skin reactions, including chemical burns, have been documented.

Improper use of the product has led to cases of eye injury. Furthermore, instances of ototoxicity have been reported when the solution was instilled in the middle ear through perforated eardrums. These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

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 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)