Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

Description

Maxiclens™ is an antiseptic skin cleanser containing 4% chlorhexidine gluconate, indicated for external use only. The product is distributed by Henry Schein Inc., located at 135 Duryea Road, Melville, NY 11747, USA. It is available in a net volume of 32 fluid ounces (1 quart or 946 mL) and is manufactured in the United States. Care should be taken to prevent freezing. Users are advised that chlorhexidine gluconate skin cleansers may cause staining when used in conjunction with chlorine-releasing products, such as chlorine bleach; therefore, it is recommended to rinse thoroughly and utilize only non-chlorine detergents for laundering or cleaning. The National Drug Code (NDC) for this product is 0404-0175-02.

Uses and Indications

This drug is indicated for use as a surgical hand scrub, 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, assisting in the reduction of bacteria that may potentially cause disease. Additionally, this drug serves as a skin wound and general skin cleanser, helping to reduce bacteria on the skin.

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

Dosage and Administration

Healthcare professionals are advised to use this product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. The product should be used at full strength and must not be diluted.

For surgical hand scrubbing, the following procedure should be followed:

1. Remove all jewelry.

2. Wet hands and forearms with water.

3. Apply 5 mL of the product.

4. Scrub hands and forearms for 3 minutes, ensuring to pay particular attention to the nails, cuticles, and interdigital spaces.

5. Rinse thoroughly with water.

6. Repeat the process by washing for an additional 3 minutes with another 5 mL of the product.

7. Rinse again under running water.

8. Dry hands and forearms thoroughly.

For healthcare personnel handwashing, the procedure is as follows:

1. Wet hands with water.

2. Dispense approximately 5 mL of the product into cupped hands.

3. Wash hands vigorously for 30 seconds.

4. Rinse and dry hands thoroughly.

When using the product as a skin wound and general skin cleanser, the following steps should be taken:

1. Thoroughly rinse the area to be cleansed with water.

2. Apply the minimum amount of product necessary to cover the skin or wound area and wash gently.

3. Rinse thoroughly with water.

4. Rinse again thoroughly to ensure complete removal of the product.

Contraindications

Use of this preparation is contraindicated in the following situations:

• Patients with a known allergy to chlorhexidine gluconate or any other component of the formulation.

• As a preoperative skin preparation, particularly on the head or face, due to the risk of adverse reactions.

• In contact with the meninges, as this may lead to serious complications.

• In the genital area, to avoid potential irritation or adverse effects.

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. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

Individuals with known allergies to chlorhexidine gluconate or any other components of this formulation should refrain from using this product. It is contraindicated for use as a patient preoperative skin preparation, particularly on the head or face, and should not be applied in contact with the meninges or in the genital area.

Healthcare professionals should advise patients to discontinue use and consult a physician if any irritation, sensitization, or allergic reaction occurs and persists for 72 hours, as these symptoms may indicate a serious underlying condition.

In cases of accidental ingestion, immediate medical attention is required. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware that it is for external use only. There is a potential for severe allergic reactions, which may manifest as symptoms including 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.

Additionally, if irritation, sensitization, or any allergic reaction occurs and persists for 72 hours, patients should stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, such as 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.

No specific drug or laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (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 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.

Pregnancy

The available data regarding the use of this medication during pregnancy do not indicate any specific safety concerns. There are no dosage modifications recommended for pregnant patients, nor are there any special precautions outlined for use during pregnancy. Healthcare professionals should consider the absence of explicit safety concerns while evaluating the potential benefits and risks of this medication in pregnant individuals. As always, clinical judgment should guide treatment decisions in this population.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 context of overdosage, it is important to note that specific information regarding the overdosage of this medication is not provided in the available sections of the drug insert.

Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose, even in the absence of detailed guidance. In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any adverse effects and symptoms that may arise.

Management procedures should include supportive care and symptomatic treatment as necessary. Consultation with a poison control center or a medical toxicologist may be beneficial for further guidance on managing potential overdosage scenarios.

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 the product. Reports of allergic reactions, including anaphylaxis, have been received, alongside skin reactions such as rash, pruritus, and urticaria. Additionally, cases of serious allergic reactions, including anaphylaxis, have been documented.

There have been reports of chemical burns, particularly in premature infants and infants under 2 months of age. Instances of eye injury have also been noted, occurring when the product was used improperly, which led to serious and permanent damage. Furthermore, irritation and sensitization following the use of the product have been reported.

Patient Counseling

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

Patients should be informed not to use this product if they are allergic to chlorhexidine gluconate or any other ingredient in the formulation. It is important to emphasize that this product should not be used as a patient preoperative skin preparation, particularly on the head or face, and should not come into contact with the meninges or be applied in the genital area.

Healthcare providers should counsel patients to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these may indicate a serious condition.

When using this product, patients must be cautioned 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. In the event of contact with these areas, patients should rinse with cold water immediately.

Additionally, healthcare providers should inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. They should also advise against repeated general skin cleansing of large body areas unless an underlying condition necessitates a reduction in the bacterial population of the skin.

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 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). Proper storage conditions are crucial to ensure the integrity and quality of the product throughout its shelf life.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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