Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser, formulated for external use only. This product is dye-free and is packaged in a tamper-evident container; it should not be used if the shrink seal neckband is broken or missing. The solution is available in an 18 fluid ounce (532 mL) bottle. The National Drug Code (NDC) for this product is 11822-0891-2. It is important to note that this product is not manufactured or distributed by Molnlycke Healthcare, the owner of the registered trademark Hibiclens®.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that potentially can cause disease. It is also indicated for skin wound and general skin cleansing.

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

Dosage and Administration

Healthcare personnel should initiate handwashing by wetting hands with water. Following this, they must dispense 4 full pumps (6 grams) of the product into cupped hands and wash vigorously for a duration of 15 seconds. It is essential to rinse hands thoroughly and dry them completely.

For 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 adequately cover the skin or wound area should then be applied, followed by gentle washing. After cleansing, the area must be rinsed thoroughly once again.

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

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.

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 a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may signify a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and effective management of any complications that may arise.

Side Effects

Patients may experience a range of adverse reactions associated with this product. A significant concern is the potential for severe allergic reactions, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative that patients discontinue use immediately and seek medical assistance.

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

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining. It is advisable to avoid concurrent use of chlorhexidine gluconate with chlorine-releasing products to prevent this adverse effect. No specific dosage adjustments are necessary; however, monitoring for staining is recommended if these products are used in proximity.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly premature infants and those under two 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

There are no specific warnings or precautions regarding the use of chlorhexidine gluconate 4% solution during pregnancy. The available data does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to the fetus. Additionally, the prescribing information does not provide guidance on dosage modifications or special precautions for individuals who are pregnant. Healthcare professionals should consider the absence of specific data when advising pregnant patients on the use of this product.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under two 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose. Healthcare professionals are advised to follow established protocols for managing overdose situations, which may include supportive care and symptomatic treatment based on the specific substance involved.

Monitoring the patient closely for any signs of toxicity is essential, as symptoms may vary depending on the agent involved. Early recognition and management can significantly improve outcomes in cases of overdose.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which may include severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash.

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

Additionally, 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. It is important to instruct patients 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 Antiseptic Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)