Antiseptic Skin Cleanser

Description

NDC 11822-0116-5, Daylogic Advanced Antimicrobial Handwash contains 4% chlorhexidine gluconate as its active ingredient. This antiseptic solution is clinically proven to reduce bacteria on the skin and is formulated for use by healthcare professionals. The product is FDA approved and is free from phthalates, triclosan, and dyes. It is presented in an 8 fl oz (237 mL) container.

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 scrubbing requires the following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. Approximately 5 mL of the product should be applied using a wet brush, ensuring a thorough scrub for 3 minutes, with particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. After scrubbing, the hands and forearms must be rinsed thoroughly. This should be followed by an additional wash for 3 minutes using another 5 mL of the product, which should also be rinsed under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. About 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for approximately 15 seconds. After washing, hands should be rinsed and dried thoroughly.

When performing 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. The area must be rinsed again thoroughly 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 component of 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, or the Poison Control Center should be contacted for guidance.

Healthcare providers should advise patients to stop using the product and consult their physician if they experience any signs of irritation, sensitization, or an allergic reaction, as these may indicate a serious underlying condition. Monitoring for these adverse effects is essential to ensure patient safety and appropriate management.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant allergy alert, as this product has the potential to cause severe allergic reactions. Symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

In addition to severe allergic reactions, patients may also experience irritation, sensitization, or other allergic reactions. These symptoms could indicate the presence of a serious condition and should be monitored closely. It is essential for patients to be aware of these potential adverse reactions and to seek medical attention if they occur.

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

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy. The available prescribing information does not mention any contraindications or risks associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. The text also does not provide any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of chlorhexidine gluconate.

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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 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 overdosage. Healthcare professionals are advised to monitor the patient closely and provide supportive care as necessary.

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 revealed that chlorhexidine gluconate may cause severe allergic reactions. Reported symptoms include wheezing, difficulty breathing, shock, facial swelling, hives, and rash. In cases of an allergic reaction, it is advised to discontinue use and seek medical assistance immediately. Additionally, there have been reports of irritation, sensitization, or allergic reactions associated with the use of this product, which may indicate a serious condition.

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. They must be instructed to discontinue use and consult a healthcare provider if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, patients should be reminded to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these 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.

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, as temperatures above 40°C (104°F) may compromise the integrity of the product. Proper container requirements should be adhered to, ensuring that the product is kept in a suitable environment to maintain its efficacy. Special handling needs should be observed to prevent any potential degradation of the product during storage.

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.

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