Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser formulated for external use only. This solution is dye-free, ensuring minimal risk of skin irritation associated with coloring agents. The product is available in a net volume of 8 fluid ounces (237 mL).

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 scrubs should begin with wetting the hands and forearms under running 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 to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms should be rinsed thoroughly. This is followed by an additional wash for 3 minutes using another 5 mL of the product, after which the hands and forearms must be rinsed again 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 should be rinsed thoroughly and dried.

In the case of skin wound and general skin cleansing, the area to be cleaned must 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 should be rinsed thoroughly once more.

Contraindications

Use of this product is contraindicated in the following situations:

• Known allergy to chlorhexidine gluconate or any other component of the formulation.

• Application in contact with the meninges due to the risk of severe adverse effects.

• Use in the genital area, as it may lead to 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. 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 with water without delay. Additionally, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Repeated cleansing of large body areas is discouraged unless specifically recommended by a healthcare provider.

In the case of accidental 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 underlying condition.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A notable 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 to discontinue use immediately and seek medical assistance.

Participants should be advised against using this product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained within. Additionally, the product should not be applied in contact with the meninges or in the genital area.

While 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 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.

Patients are advised to stop using the product 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 or contact with a Poison Control center is recommended.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, leading to staining. It is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize non-chlorine detergents to prevent this interaction.

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 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 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 careful consideration and caution in this demographic.

Healthcare providers are advised to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place to mitigate any adverse effects. Regular monitoring for signs of irritation or other complications is recommended to ensure patient safety and treatment efficacy.

Pregnancy

Safety during pregnancy has not been established for this medication. While there are no specific contraindications noted for use during pregnancy, caution is advised when prescribing to pregnant patients.

Healthcare professionals should be aware that the medication may pose risks, particularly in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Therefore, careful consideration and monitoring are recommended when administering this medication to women of childbearing potential.

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 text regarding dosage adjustments, special monitoring, or safety considerations. 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, although specific recommendations are not provided.

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 strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 safety profile in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of this product. Reports include allergic reactions, which may present as severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, there have been instances of irritation and sensitization reported, alongside other allergic reactions. These events have been documented through voluntary reports and surveillance programs.

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. Healthcare providers must emphasize the importance of discontinuing use and consulting a doctor if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

When instructing patients on the proper use of this product, providers should stress the necessity of keeping the solution away from the eyes, ears, and mouth. Patients should be made aware that contact with these areas may result in serious and permanent eye injury or potential deafness if the solution is 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.

Additionally, healthcare providers should inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. They should also advise against repeated general skin cleansing of large body areas unless specifically recommended by a healthcare provider.

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° to 25° C (68° to 77° F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F), to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety 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)