Antiseptic Skin Cleanser

Description

DYNA-HEX 4® is an antiseptic solution containing 4% Chlorhexidine Gluconate. It is intended for external use only and is distributed by Xttrium Laboratories, Inc. The product is available in a net volume of 4 fluid ounces (118 mL). The National Drug Code (NDC) for this formulation is 0116-1061-04.

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 indicated for patient preoperative skin preparation, ensuring the preparation of the patient's skin prior to surgery. Furthermore, it is suitable 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 operator 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. The procedure should be repeated with an additional 5 mL of product, scrubbing for another 3 minutes before rinsing under running water. It is essential to dry the hands and forearms thoroughly after completion.

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

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, 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 to ensure optimal preparation.

For skin wound and general skin cleaning, the area intended for cleaning 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:

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

• Contact with the meninges, due to the risk of serious complications.

• Application in the genital area, as it may lead to adverse effects.

• Use as a preoperative skin preparation on the head or face, to avoid potential complications.

Warnings and Precautions

For external use only. Healthcare professionals should be aware that this product carries a significant risk of 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.

In cases where the product is ingested, prompt medical attention is necessary. Healthcare providers should advise patients to contact a Poison Control Center or seek emergency medical help without delay.

Patients should be instructed to stop using the product and consult their healthcare provider if they experience any signs of irritation, sensitization, or allergic reactions. These symptoms may indicate a serious underlying condition that requires further evaluation and management.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant allergy alert, as the 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 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 for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

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. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. It is essential to assess the safety and efficacy of the treatment in geriatric patients, taking into account their overall health status and any comorbid conditions that may influence the therapeutic outcome.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy in the available prescribing information. The insert does not mention any contraindications or risks associated with the use of this product during pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. Furthermore, the insert does not include any special precautions regarding the use of this product during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. 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 overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

In the absence of detailed guidance, it is recommended that clinicians follow standard protocols for managing drug overdosage, which may include symptomatic treatment and supportive measures. If further information becomes available or if the situation warrants, consultation with a poison control center or a medical toxicologist is encouraged to ensure appropriate management.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notably, allergic reactions have been reported, including instances of anaphylaxis. Additional skin reactions such as rash, pruritus, and urticaria have also been documented.

Serious allergic reactions have been observed, with reports indicating symptoms such as wheezing, difficulty breathing, shock, facial swelling, and hives. Furthermore, cases of chemical burns and irritation have been noted, particularly among premature infants and infants under 2 months of age.

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 physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

When instructing patients on the application of this product, healthcare providers should stress the necessity of keeping it 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 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 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 for identification. It should be stored at a temperature range of 20-25ºC (68-77ºF). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The route of administration for the product is topical. Clinicians should counsel patients 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. In the event of contact with these areas, patients should rinse thoroughly with water.

Patients should be advised against the routine treatment of wounds that extend beyond the superficial layers of the skin and to refrain from repeated general skin cleansing of large body areas unless directed by a healthcare provider. They should discontinue use and consult a doctor if any irritation, sensitization, or allergic reaction occurs, as these may indicate a serious condition. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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)