Chlorhexidine Gluconate

Description

NDC 68599-5400-2 identifies a non-sterile antiseptic skin cleanser manufactured by McKesson, containing 4% chlorhexidine gluconate solution. This formulation is designed to reduce the number of microorganisms on the skin prior to surgical procedures or patient care. The product is packaged in single-use vials, with each vial containing 0.5 fluid ounces (15 mL). Each box contains 50 vials, and the manufacturer reference number is 16-CHG15.

Uses and Indications

This drug is indicated for surgical hand scrubs, significantly reducing the number of microorganisms on the hands and forearms prior to surgery or patient care. It is also indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease.

Additionally, this drug is indicated for patient preoperative skin preparation, facilitating the preparation of the patient's skin prior to surgery, as well as for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubs should begin with wetting the hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. An additional wash with 5 mL of the product is required for another 3 minutes, after which the hands should be rinsed under running water and dried thoroughly.

For healthcare personnel handwashing, hands should be wetted with water before dispensing about 5 mL of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, followed by thorough rinsing and drying of the hands.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel.

For skin wound and general skin cleaning, 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. A thorough rinse is required once again to complete the cleaning process.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other components of 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.

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its use in these sensitive areas.

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.

It is important to note that this product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer. For further information, please refer to www.P65Warnings.ca.gov.

General precautions must be observed when using this product. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay. The product should not be used by individuals with known allergies to chlorhexidine gluconate or any other components of the formulation.

This product is contraindicated for use in contact with the meninges and should not be applied to the genital area. Additionally, it is not recommended for use as a preoperative skin preparation on the head or face. Care should be taken 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 imperative to rinse thoroughly with water immediately.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

In the event of an allergic reaction, the use of this product should be discontinued immediately, and medical assistance should be sought. Users should also stop using the product and consult a healthcare professional if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. A severe allergic reaction is a significant concern, with symptoms that may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is crucial to avoid using this product in certain situations. Patients should not use it if they are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, the product should not be applied in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

While using this product, patients must take precautions to prevent serious complications. The solution should be kept out of the eyes, ears, and mouth, as contact with these areas may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. If the solution inadvertently contacts these areas, it should be rinsed out promptly and 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients are also 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

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Chlorhexidine Gluconate (antiseptic skin cleanser). 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

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, and no special precautions regarding the use of this medication during pregnancy are included in the text. Healthcare professionals should continue to evaluate the benefits and risks when prescribing this medication 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 effects when this product is used by lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed of the potential for allergic reactions. They must be advised to discontinue use and seek medical assistance right away if they experience any signs of an allergic reaction. It is crucial to emphasize that this product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredients contained in the formulation.

Healthcare providers should caution patients against using this product in contact with the meninges or in the genital area. Additionally, it should not be used as a preoperative skin preparation for the head or face.

When using this product, patients must be instructed to avoid contact with the eyes, ears, and mouth, as it may cause serious and permanent eye injury if introduced into the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Providers should inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients should be advised to stop using the product and consult their doctor if they experience irritation, sensitization, or any allergic reactions, as these may indicate a serious condition.

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 temperature range of 68-77ºF (20-25°C). Care should be taken to avoid exposure to excessive heat, which should not exceed 104°F (40°C). Proper storage conditions are crucial 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 Chlorhexidine Gluconate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)