Antiseptic Skin Cleanser

Description

NDC 0116-1061-15, DYNA-HEX 4 ® is a non-sterile antiseptic solution containing 4% Chlorhexidine Gluconate. It is intended for external use only and is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. The product is packaged in net contents of 50 single-use packettes, each containing 0.5 fl oz (15 mL) of the solution.

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 scrubbing requires the healthcare professional 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 the initial scrub, the hands and forearms must be rinsed thoroughly. An additional wash with 5 mL of the product should be performed for another 3 minutes, followed by rinsing 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 15 seconds. After washing, the hands must be rinsed and dried thoroughly.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for a minimum of 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 cleaning, 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. A thorough rinse is required once again to complete the cleaning process.

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 allergic reactions.

The product must not be applied in contact with the meninges, as this may lead to serious complications.

It is also contraindicated for use in the genital area, where it may cause irritation or adverse effects.

Additionally, the product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its application in these sensitive areas.

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 well-being.

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant risk of severe allergic reactions associated with its use. Symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

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

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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.

Healthcare providers are advised to consider these safety concerns and to adjust dosages accordingly, ensuring that the benefits of treatment outweigh the risks for geriatric patients. Regular assessment of the patient's response to therapy and any adverse effects is recommended to optimize safety and efficacy in this demographic.

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 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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive care measures and consider symptomatic treatment as necessary.

For further guidance, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management strategies are employed.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include severe manifestations such as wheezing or 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 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, the genital area, or as a preoperative skin preparation for the head or face. Providers should emphasize the importance of discontinuing use and consulting a doctor if any signs of irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition.

When instructing patients on the proper use of the product, healthcare 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 deafness if the solution is instilled in the middle ear through perforated eardrums. In the event of accidental contact, patients should rinse the affected area promptly and thoroughly with water.

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 or application to 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 for identification. It is essential to store the product at a controlled room temperature of 20-25ºC (68-77ºF). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF), to maintain product integrity and efficacy. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should counsel patients on the potential for severe allergic reactions, which may manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. Patients should be advised to discontinue use and seek immediate medical attention if any allergic reactions occur.

It is crucial to avoid use in individuals with known allergies to chlorhexidine gluconate or any other ingredients in the formulation, as well as in specific anatomical areas such as the meninges, genital area, or as a preoperative skin preparation for the head or face. Patients should be instructed to keep the product away from the eyes, ears, and mouth to prevent serious injuries, including permanent eye damage or deafness. Additionally, wounds that extend beyond superficial layers should not be treated routinely, and general skin cleansing over large areas should only be performed under healthcare provider guidance. Patients should stop use and consult a doctor if irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition. The product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

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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