Antiseptic Skin Cleanser

Description

This antiseptic skin cleanser contains Chlorhexidine Gluconate 4% solution and is formulated for external use only. It is a dye-free product available in two sizes: 8 fluid ounces (237 mL) and 16 fluid ounces (473 mL). The product should not be used if the safety seal is broken or missing.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that may potentially cause disease. It is also indicated for skin wound and general skin cleaning.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 a duration of about 15 seconds. After washing, hands must be rinsed thoroughly and dried completely.

For skin wound and normal 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 ingredient in this formulation.

• Contact with the meninges, as this may pose significant risks.

• Application in the genital area, due to potential adverse effects.

Additionally, caution is advised to prevent contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent injury, including potential deafness if introduced into the middle ear through perforated eardrums. If contact occurs, the area should be rinsed promptly and thoroughly with water. This product should not be used on wounds that extend beyond the superficial layers of the skin, and repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider.

Warnings and Precautions

For external use only. This product carries an allergy alert, as it may induce a severe allergic reaction in some individuals. Symptoms of such a 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.

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained within. Additionally, it is contraindicated for use in contact with the meninges and should not be applied to the genital area.

When utilizing this product, it is essential to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled into the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it must be rinsed out promptly and 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 specifically advised by a healthcare provider.

Healthcare professionals should instruct 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.

This product must be kept out of reach of children. In the event of ingestion, immediate medical help should be sought or contact with a Poison Control Center is recommended.

It is important to note that this product contains a chemical recognized by the State of California as a potential carcinogen.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A notable concern is the potential for severe allergic reactions, 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 critical to avoid using this product in individuals with known allergies to chlorhexidine gluconate or any other ingredients contained within. Additionally, the product should not be applied in contact with the meninges or in the genital area.

During use, patients should take precautions to prevent contact with the eyes, ears, and mouth, as exposure to these areas may lead to serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse 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.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

This product also contains a chemical recognized by the State of California as a potential carcinogen.

To ensure safety, the product should be kept out of reach of children, and in the event of accidental ingestion, medical help or contact with a Poison Control Center should be sought immediately.

Drug Interactions

The use of this product in conjunction with chlorine-releasing agents may result in staining. It is advised to thoroughly rinse the product after use and to exclusively utilize non-chlorine detergents to mitigate this risk.

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 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 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 individual patient's condition and adjust the dosage as necessary to ensure safety and efficacy.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications indicated for the use of this medication during pregnancy. Additionally, there are no special precautions outlined for pregnant individuals. As with any medication, healthcare professionals are encouraged to weigh the potential benefits against any risks when considering treatment options for pregnant patients. Further studies may be necessary to fully understand the implications of this medication on fetal outcomes. Women of childbearing potential should be counseled accordingly.

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 these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse reactions when this product is used by lactating mothers.

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 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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 several adverse reactions associated with the use of this product. Reports include allergic reactions, which encompass severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation and sensitization have been documented, alongside further allergic reactions occurring during the use of the 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 important to inform patients that this product contains a chemical recognized by the State of California as a potential carcinogen.

Patients should be cautioned to keep the product away from the eyes, ears, and mouth, as contact with these areas 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 sensitive areas, patients should be instructed to rinse thoroughly with water as soon as possible.

Healthcare providers should also discuss the appropriate use of the product, emphasizing that wounds involving more than the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Patients should be informed to discontinue use and consult their doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25° C (68° to 77° F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F), to maintain product integrity. Proper storage conditions are essential to ensure the efficacy and safety 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)