Antiseptic Skin Cleanser

Description

NDC 62011-0237-1. This product is an antiseptic skin cleanser containing chlorhexidine gluconate 4% solution, formulated for external use only. It is a dye-free formulation designed for antiseptic and antimicrobial purposes. The product is packaged in an 8 fl oz (237 mL) container and is comparable to the active ingredient found in Hibiclens®.

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 healthcare professional to first wet their hands and forearms under running water. Approximately 5 mL of the product should be dispensed, and the individual must scrub for 3 minutes using a wet brush, ensuring meticulous attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms should be rinsed thoroughly. An additional wash is required, using another 5 mL of the product for an additional 3 minutes, followed by thorough rinsing under running water. It is essential to dry the hands and forearms thoroughly after the procedure.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense approximately 5 mL of the product into cupped hands. The hands should be washed vigorously for about 15 seconds, followed by thorough rinsing and drying.

In the case of skin wound and general skin cleansing, the area to be cleaned must be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should be applied, and the area should be washed gently. A final thorough rinsing is required to ensure complete removal of the product.

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.

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

Additionally, the product should not be applied in the genital area, as this may result in adverse effects.

Warnings and Precautions

For external use only, this product carries the potential to induce 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.

This product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other component of the formulation. Additionally, it should not be applied in contact with the meninges or used in the genital area. Ingestion of the product necessitates prompt medical attention or contact with a Poison Control Center.

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. Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is essential to rinse thoroughly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, 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.

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 may include irritation, sensitization, or allergic reactions. Should any of these symptoms occur, patients are instructed to stop using the product and consult a healthcare professional, as these may indicate a serious condition.

When using this product, it is essential 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. If the solution comes into contact with these 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. Repeated general skin cleansing of large body areas is not recommended unless necessary to reduce the bacterial population due to an underlying condition.

Patients should be aware of these potential adverse reactions and take appropriate precautions to ensure safe use of the product.

Drug Interactions

This product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer. Users should be aware of this potential risk when using the product.

In addition, the use of chlorhexidine gluconate skin cleansers in conjunction with chlorine-releasing products may result in staining. It is advised to thoroughly rinse the skin after using chlorhexidine gluconate and to utilize only non-chlorine detergents to prevent this interaction.

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 be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to closely monitor these patients to mitigate potential risks associated with their use.

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

The use of this medication during pregnancy has not been specifically addressed in the available data. There are no explicit safety concerns noted for pregnant patients, nor are there any dosage modifications recommended for this population. Additionally, no special precautions regarding the use of this medication during pregnancy have been provided. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to women of childbearing potential and during pregnancy, as individual circumstances may vary.

Lactation

Lactating mothers should use this product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. There is limited data on the excretion of this product in breast milk and its effects on breastfed infants. Therefore, healthcare professionals are advised to consider the potential risks and benefits when recommending this product to lactating mothers.

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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 have not been defined.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action 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

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 identified several adverse reactions associated with the use of the product. Reports have included allergic reactions, which may manifest as severe symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised that the user discontinue use and seek medical assistance immediately.

Additionally, there have been instances of irritation, sensitization, or allergic reactions that could suggest the presence of a serious condition. These findings underscore the importance of monitoring for adverse effects and responding promptly to any signs of an allergic response.

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 physician 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 the solution is 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a 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). Proper storage conditions are essential to maintain the integrity and efficacy 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.

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