Antiseptic Skin Cleanser

Description

TopCare Health Antiseptic Skin Cleanser is a dye-free formulation containing chlorhexidine gluconate 4% solution as the active ingredient. This antiseptic and antimicrobial skin cleanser is intended for external use only and is packaged in an 8 fluid ounce (237 mL) container. The product is comparable to Hibiclens® and is designed for effective skin cleansing. The National Drug Code (NDC) for this product is 36800-401-50.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash to help reduce bacteria that potentially can cause disease. It is also indicated for skin wound and general skin cleansing.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Healthcare personnel should begin by wetting their hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for about 15 seconds. After washing, hands must be rinsed thoroughly and dried.

For skin wound and general skin cleansing, 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. The area must be rinsed again thoroughly to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

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

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

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

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.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas is discouraged unless specifically recommended by a healthcare provider.

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.

In cases of accidental ingestion, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of the potential for 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, it is imperative to discontinue use immediately and seek medical assistance.

This product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation. It should not be used in contact with the meninges or in the genital area.

During the use of this product, it is crucial to 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. Should the solution come into contact with these areas, it is essential to rinse 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 only be performed under the guidance of a healthcare provider.

Patients are advised to 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

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 rinse the skin thoroughly 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 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 enhanced monitoring for geriatric patients, especially in the context of their overall health status and any concurrent medications they may be taking.

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 caring for infants in the specified age group.

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 drug insert 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 absence of detailed guidance 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

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 chlorhexidine gluconate. Reports have included allergic reactions, which may range from mild to severe, potentially manifesting as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been noted, which may indicate a serious condition.

Caution is advised when using this product in premature infants or infants under 2 months of age, as there is a risk of irritation or chemical burns in this population.

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 healthcare professional 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 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 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 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential to maintain the integrity 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)