Antiseptic Skin Cleanser

Description

NDC 70000-0407-1 identifies this product as Leader Antiseptic Skin Cleanser, which contains Chlorhexidine Gluconate 4% Solution. This formulation serves as an antiseptic and antimicrobial skin cleanser, suitable for hand hygiene, skin wound care, and general skin cleansing. The product is packaged in an 8 fl oz (237 mL) container and is intended for external use only. It is important to note that tampering is evident; do not use if the shrink seal neckband is broken or missing. This product can be compared to Hibiclens® based on its active ingredients. The current version is CIN 5454889 REV. 8/23.

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 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 general 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 thorough rinse is required once again to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, the product should not be applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

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.

Monitoring for signs of irritation, sensitization, or any allergic reaction is essential. Should any of these symptoms manifest, the healthcare provider should advise the patient to stop using the product and consult a physician, as these may indicate a serious condition.

In cases of accidental ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center without delay. Prompt action is necessary to ensure patient safety and appropriate management of the situation.

Side Effects

Patients using this product should be aware that it is for external use only. There is a potential risk of 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.

Additionally, patients should 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

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining. It is advisable to avoid concurrent use of chlorhexidine gluconate with chlorine-releasing products to prevent this adverse effect. Monitoring for any signs of staining is recommended if such products are used in proximity.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate). 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 risk of 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 and appropriate dose adjustments may be necessary to ensure safety and efficacy in geriatric patients.

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 regarding the importance of discussing any planned pregnancies with their healthcare provider prior to initiating treatment.

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 the mother is using this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of chlorhexidine gluconate. Reports have included allergic reactions, which may manifest as severe allergic responses such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been noted, which may suggest the potential for serious conditions. These events have been reported voluntarily or through surveillance programs.

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 symptoms 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 if 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 is essential to store the product at a controlled room temperature of 20-25 ºC (68-77 ºF). Care should be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40 ºC (104 ºF), to maintain product integrity. Proper storage conditions are crucial for ensuring 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)