Antiseptic Skin Cleanser

Description

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser formulated without dyes. It is designed for effective skin cleansing and is available in three sizes: 8 FL OZ (237 mL), 16 FL OZ (473 mL), and 18 FL OZ (532 mL). The product features a tamper-evident seal, and it 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 care and general skin cleansing.

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 about 15 seconds. After washing, hands must be rinsed thoroughly and dried.

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 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 severe adverse effects.

• Use in the genital area, as it may lead to irritation or other complications.

Warnings and Precautions

For external use only. This product carries a significant allergy alert, as it may induce a severe allergic reaction in some individuals. Symptoms of such a reaction may include wheezing or difficulty breathing, 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 the formulation. 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 inadvertently contact 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. In the case of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

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, 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.

In terms of serious risks associated with the use of this product, it is imperative to avoid contact with the meninges and the genital area. Additionally, care must be taken to prevent the solution from entering the eyes, ears, and mouth, as this 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 recommended to rinse thoroughly with water.

Common adverse reactions may include irritation, sensitization, or allergic reactions. Patients are advised to stop using the product and consult a healthcare provider if any of these symptoms occur, as they may indicate a serious condition. 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 professional.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, leading to staining. To mitigate this interaction, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents in conjunction with these cleansers.

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. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. There are no specific contraindications for its use in pregnant patients, and the prescribing information does not detail any specific risks to the fetus. Additionally, no dosage modifications for pregnant individuals are provided, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider the lack of established safety data when prescribing chlorhexidine gluconate to women of childbearing potential.

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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. 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 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 drug. 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; 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 relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other nonclinical toxicology data. Additionally, there is no available information pertaining to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, facial swelling, hives, and rash. In cases of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if irritation, sensitization, or any allergic reaction occurs, as these may indicate a serious condition. Special care should be taken when using this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

Furthermore, it is important to note that this product contains cocamide DEA, a chemical recognized by the State of California as a potential carcinogen.

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 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 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 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), 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)