Antiseptic Skin Cleanser

Description

Good Neighbor Pharmacy Antiseptic Skin Cleanser contains Chlorhexidine Gluconate 4% solution, available in two formulations: an 8 fl oz (237 mL) bottle (NDC 46122-137-34) and a 16 fl oz (473 mL) bottle (NDC 46122-137-43). This antiseptic/antimicrobial skin cleanser is dye-free and intended for external use only. Each formulation features a tamper-evident seal, and it should not be used if the safety seal is broken or missing. The product is comparable to the active ingredient in Hibiclens®. The product is identified by ABC #10286304 for the 8 fl oz size and ABC #10286265 for the 16 fl oz size. The labeling was last revised in February 2024.

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 cleansing.

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

Dosage and Administration

Healthcare personnel should initiate hand hygiene by wetting 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. It is essential to rinse hands thoroughly and dry them completely.

For skin wound and normal skin cleansing, the area to be cleaned must 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. A final thorough rinse 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 ingredient in 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

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. Symptoms indicative of an allergic 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.

Users should also stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. In cases of accidental ingestion, medical help should be sought or a Poison Control Center contacted without delay.

The product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. It should not be used in contact with the meninges or in the genital area.

When administering 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 introduced into the middle ear through perforated eardrums. Should the solution come into contact with these areas, it must 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 specifically advised by a healthcare provider.

Side Effects

This product may cause severe allergic reactions in some patients. Symptoms of an allergic reaction can 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.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, the product should not be applied in contact with the meninges or in the genital area.

When using 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 advised 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 stop using the product and consult a doctor if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. It is also important to keep this product out of reach of children; if swallowed, medical help should be sought immediately or contact with a Poison Control Center should be made.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, leading to staining. It is advised to rinse the skin thoroughly after use 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 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 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 product has not been specifically studied in pregnant patients, and there are no detailed safety concerns regarding its use during pregnancy. Current data does not indicate any need for dosage modifications for pregnant individuals. Additionally, no special precautions are outlined for the use of this product in pregnant patients. Healthcare professionals should consider the available information and weigh the potential benefits against any unknown risks when prescribing this product 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 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 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 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 of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended until they are stabilized. It is also advisable to gather information regarding the amount ingested and the time of ingestion to facilitate appropriate treatment decisions.

In summary, swift action and comprehensive management are key components in addressing overdosage cases effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Reported symptoms include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In cases of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance. Additionally, users are instructed to stop use and consult a healthcare professional if irritation, sensitization, or any allergic reaction occurs, as these may indicate a serious condition.

Furthermore, it is important to note that this product may expose users to coconut oil diethanolamine condensate (cocamide diethanolamine), a substance 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 provider 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 for identification. It should be stored at a controlled room temperature of 20° to 25° C (68° to 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.

View product document (PDF)