Antiseptic Skin Cleanser

Description

NDC 42939-103-04 identifies an antiseptic skin cleanser formulated with Chlorhexidine Gluconate 2% Topical Solution, USP. This product serves as an antiseptic and antimicrobial skin cleanser intended for external use only. It is packaged in a 32 fl. oz. (974 mL) container. The product features a tamper-evident seal, and it should not be used if the safety seal is broken or missing. AVA Incorporated is the manufacturer of this formulation.

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 utilized for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgery. 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 scrub requires the operator to wet 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 is given 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. The procedure should be repeated with an additional 5 ml of product for another 3 minutes, followed by thorough rinsing under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense about 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.

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 and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel.

For 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 be applied, followed by gentle washing. The area must then be rinsed thoroughly 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 components of the formulation.

• Application in contact with the meninges is contraindicated due to the risk of serious complications.

• Use in the genital area is not recommended to avoid potential irritation or adverse effects.

• The product should not be utilized as a preoperative skin preparation for the head or face to prevent possible adverse reactions.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other components of the formulation. It should not be applied in contact with the meninges, in the genital area, or utilized as a preoperative skin preparation for the head or face.

When using this product, it is imperative to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury if the solution is introduced into the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas is discouraged unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

This product should be kept 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 recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation. The product should not be applied in contact with the meninges, in the genital area, or used as a preoperative skin preparation for the head or face.

During use, it is critical to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. In the event that the solution comes into contact with these sensitive areas, it should be rinsed out promptly and thoroughly with water. Additionally, 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate). 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 caution in administration. It is advisable to consider the specific needs and health status of geriatric patients when determining the appropriateness of this treatment, ensuring that any risks are carefully weighed against the benefits.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these vulnerable populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be at risk of exposure to premature or very young infants.

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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse reactions when the mother is using this product.

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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

Use of the product in premature infants or infants under 2 months of age should be approached with caution due to the potential for irritation or chemical burns. No information is available regarding teratogenic effects, and there are no documented findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has indicated that caution is advised when using this product in premature infants or infants under 2 months of age. Reports suggest that these products may lead to irritation or chemical burns in this vulnerable population.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

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

When 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 if the product is placed or retained in the eye during surgical procedures, or may cause deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, patients must rinse them promptly and thoroughly with water.

Additionally, patients should be cautioned that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Repeated general skin cleansing of large body areas should also be avoided unless necessary to reduce the bacterial population of the skin due to an underlying condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°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 crucial for ensuring 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)