Antiseptic Skin Cleanser

Description

DYNA-HEX 4® is an antiseptic solution containing 4% Chlorhexidine Gluconate. It is available in various net contents: 4 fl oz (118 mL), 8 fl oz (237 mL), 16 fl oz (473 mL), 18 fl oz (532 mL), 32 fl oz (946 mL), and 128 fl oz (1 gal). The product is distributed by Xttrium Laboratories, Inc., located in Mount Prospect, IL 60056. DYNA-HEX 4® is intended for external use only. The formulation is designed to provide effective antiseptic properties for various applications.

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 surgery 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 steps: First, healthcare professionals should wet their hands and forearms with water. They should then apply approximately 5 ml of the product and scrub for 3 minutes using a wet brush, ensuring to pay close attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. After scrubbing, hands should be rinsed thoroughly. Following this, an additional wash is required for 3 minutes with another 5 ml of the product, which should be rinsed under running water. Finally, hands must be dried thoroughly.

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, hands should be rinsed and dried thoroughly.

When performing 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 cover the skin or wound area should then be applied, followed by gentle washing. The area should be rinsed again thoroughly to ensure complete cleaning.

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.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face when using the 4-oz formulation, due to potential safety concerns.

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 and promptly with water. 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 advised by a healthcare provider.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

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 underlying condition.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance. It is crucial to note that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation.

Common adverse reactions include irritation, sensitization, or allergic reactions, which may indicate a serious condition. Patients should stop using the product and consult a healthcare provider if any of these symptoms occur.

Additionally, caution is advised when using this product. It should not come into contact with the meninges or be applied in the genital area. The product is contraindicated for use as a preoperative skin preparation on the head or face, particularly in the 4-oz formulation.

Patients should also 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. If the solution inadvertently contacts these areas, it should be rinsed out promptly and 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.

Drug Interactions

The use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

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

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 dose adjustments and to ensure that appropriate safety measures are in place to mitigate risks associated with this medication in geriatric patients. Regular assessment of the patient's response to treatment is recommended to ensure safety and efficacy.

Pregnancy

Safety during pregnancy has not been established. While there are no specific contraindications for use during pregnancy, caution is advised. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to pregnant patients.

Additionally, special precautions should be taken when administering this product to premature infants and infants under 2 months of age, as it may cause irritation or chemical burns. It is essential to monitor these patients closely to mitigate any potential adverse effects.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants and 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 these vulnerable populations.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified reports of severe allergic reactions associated with the use of this product. These reactions include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Additionally, there have been reports of irritation, sensitization, or allergic reactions occurring with the use of this product.

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. Additionally, it should not be used as a preoperative skin preparation for the head or face, particularly in the 4-ounce formulation.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition. While using the product, patients must be reminded to keep it away from the eyes, ears, and mouth, as contact with these areas may result in 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.

Providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Furthermore, 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 20-25ºC (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 product is administered topically. Clinicians should advise patients to use the product with caution in premature infants and infants under 2 months of age, as it may cause irritation or chemical burns. It is also important to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately.

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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