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Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%

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Active ingredient
Chlorhexidine Gluconate 40 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
February 17, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 40 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
February 17, 2026
Manufacturer
Henry Schein, Inc.
Registration number
NDA019258
NDC root
0404-0219
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

Maxiclens is an antiseptic skin cleanser that contains chlorhexidine gluconate (4%), a powerful ingredient known for its ability to reduce bacteria on the skin. It is commonly used as a surgical hand scrub to significantly lower the number of microorganisms on the hands and forearms before surgery or patient care. Additionally, Maxiclens serves as a handwash for healthcare personnel, helping to minimize the risk of disease-causing bacteria, and can be used as a general skin cleanser to reduce bacteria on wounds and the skin.

This product is intended for external use only and is designed to help maintain cleanliness and hygiene in various settings, particularly in healthcare environments.

Uses

You can use this product for several important purposes. First, it serves as a surgical hand scrub, which means it significantly reduces the number of microorganisms on your hands and forearms before surgery or when providing patient care. This is crucial for preventing infections.

Additionally, it is effective as a handwash for healthcare personnel, helping to lower the amount of bacteria that could potentially cause disease. Lastly, it can be used as a skin wound and general skin cleanser, aiding in the reduction of bacteria on the skin. This makes it a versatile option for maintaining hygiene in various settings.

Dosage and Administration

When using this product, it's important to be cautious, especially if you're caring for premature infants or babies under 2 months old, as it can cause irritation or chemical burns. Always use the product at full strength and never dilute it.

For surgical hand scrubbing, start by removing any jewelry. Wet your hands and forearms with water, then apply 5 mL of the product. Scrub your hands and forearms for 3 minutes, making sure to focus on your nails, cuticles, and the spaces between your fingers. Rinse thoroughly with water, then wash again for another 3 minutes with 5 mL of the product, rinsing under running water afterward. Make sure to dry your hands completely.

If you're performing a handwash as healthcare personnel, wet your hands with water and dispense about 5 mL of the product into your cupped hands. Wash vigorously for 30 seconds, then rinse and dry thoroughly. For cleansing skin wounds or general skin areas, rinse the area with water first, then apply just enough product to cover the skin or wound. Wash gently and rinse thoroughly with water, repeating the rinse to ensure cleanliness.

What to Avoid

You should avoid using this product if you are allergic to chlorhexidine gluconate or any of its other ingredients. It is also important not to use it as a preoperative skin preparation, particularly on the head or face, and you should never apply it in contact with the meninges (the protective membranes covering the brain and spinal cord) or in the genital area.

Additionally, be aware that this product is classified as a controlled substance, which means it has the potential for abuse or misuse. Always follow these guidelines to ensure your safety and well-being.

Side Effects

This product may cause a severe allergic reaction, which can include symptoms such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash. If you experience any of these symptoms, it’s important to stop using the product and seek medical help immediately.

Additionally, if you notice any irritation, sensitization, or allergic reactions that last for 72 hours, you should stop using the product and consult a doctor, as these could indicate a more serious condition.

Warnings and Precautions

This product is for external use only and may cause a severe allergic reaction in some individuals. Symptoms of an allergic reaction can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. If you experience any of these symptoms, stop using the product immediately and seek medical help.

Please avoid using this product if you are allergic to chlorhexidine gluconate or any of its ingredients. It should not be used as a skin preparation before surgery, especially on the head or face, nor should it come into contact with the meninges (the protective membranes covering the brain and spinal cord) or be applied to the genital area. If you notice any irritation, sensitization, or allergic reaction that lasts for 72 hours, stop using the product and contact your doctor, as these may indicate a serious condition.

In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious when using certain medications, especially around infants. If you have a premature baby or an infant under 2 months old, be particularly careful, as some products can cause irritation or even chemical burns. Always consult with your healthcare provider before using any medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, it's important to use certain medications with caution, especially if your baby is a premature infant or under 2 months old. These products can potentially cause irritation or chemical burns in young infants. Always consult with your healthcare provider before using any medication to ensure it is safe for you and your baby. Your health and your baby's well-being are the top priorities, so taking these precautions can help protect both of you.

Pediatric Use

When using this product for children, especially for premature infants or those under 2 months old, it's important to be cautious. These young infants may experience irritation or even chemical burns from the product. Always ensure that the product is kept out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your vigilance can help keep your child safe.

Geriatric Use

When considering medication for older adults, it's important to be cautious, especially if you are caring for premature infants or infants younger than 2 months. These medications can potentially cause irritation or even chemical burns in this vulnerable age group.

Always consult with a healthcare professional to ensure that any treatment is safe and appropriate for the specific needs of older adults or young infants. Taking these precautions can help prevent adverse effects and ensure better health outcomes.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, which means keeping it away from temperatures above 104°F (40°C).

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity and safety. If you have any specific disposal instructions, be sure to follow them carefully to ensure safe and responsible disposal.

Additional Information

You should use this medication topically, which means applying it directly to the skin. It's important to be cautious if you are using it on premature infants or infants younger than 2 months, as it can cause irritation or even chemical burns.

If the medication is accidentally swallowed, seek medical help or contact a Poison Control Center right away for assistance.

FAQ

What is Maxiclens?

Maxiclens is an antiseptic skin cleanser containing chlorhexidine gluconate 4%, used to reduce microorganisms on the skin.

What are the main uses of Maxiclens?

Maxiclens is used as a surgical hand scrub, healthcare personnel handwash, and a skin wound and general skin cleanser.

How should I use Maxiclens for surgical hand scrubbing?

Wet your hands and forearms, apply 5 mL of Maxiclens, scrub for 3 minutes, rinse, then wash again for 3 minutes and rinse thoroughly.

Are there any warnings associated with Maxiclens?

Yes, Maxiclens can cause severe allergic reactions and should not be used if you are allergic to chlorhexidine gluconate or in certain areas like the genital area.

What should I do if I experience an allergic reaction to Maxiclens?

If you experience symptoms like wheezing, facial swelling, or rash, stop using Maxiclens and seek medical help immediately.

Can Maxiclens be used on infants?

Use Maxiclens with care in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.

What are the storage instructions for Maxiclens?

Store Maxiclens between 20-25°C (68-77°F) and avoid excessive heat above 104°F (40°C).

Is Maxiclens safe for external use?

Yes, Maxiclens is for external use only and should be kept out of the eyes, ears, and mouth.

What should I do if Maxiclens is swallowed?

If swallowed, get medical help or contact a Poison Control Center immediately.

Packaging Info

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.

Packaging configurations for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%.
Details

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.

View product document (PDF)

Description

No description information is available for the specified drug.

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 surgical procedures 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: First, remove all jewelry. Wet the hands and forearms with water, then apply 5 mL of the product. Scrub the hands and forearms for a duration of 3 minutes, ensuring to pay particular attention to the nails, cuticles, and interdigital spaces. After scrubbing, rinse thoroughly with water. Subsequently, wash for an additional 3 minutes using another 5 mL of the product, followed by rinsing under running water. Finally, dry the hands and forearms thoroughly.

For healthcare personnel handwashing, wet the hands with water and dispense approximately 5 mL of the product into cupped hands. Wash vigorously for 30 seconds, then rinse and dry the hands thoroughly.

When using the product as a skin wound and general skin cleanser, first rinse the area to be cleansed with water. Apply the minimum amount of product necessary to cover the skin or wound area and wash gently. Rinse thoroughly with water, and then 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 this formulation should not use this product due to the risk of severe allergic reactions.

This product is not to be used as a preoperative skin preparation, particularly on the head or face, as it may pose risks of adverse effects in these sensitive areas.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Additionally, the use of this preparation in the genital area is contraindicated due to potential irritation and adverse reactions.

Warnings and Precautions

For external use only. This product carries a significant risk of 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.

General precautions must be observed when using this product. It should not be applied if the patient has a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, this product is contraindicated for use as a preoperative skin preparation, particularly on the head or face, and should not come into contact with the meninges or be applied to the genital area.

Healthcare professionals should advise patients to stop using the product 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 ingestion, immediate medical attention is required. Patients should contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant allergy alert, as the product has the potential to cause severe allergic reactions. Symptoms of such reactions 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.

Additionally, if patients experience irritation, sensitization, or any allergic reaction that persists for 72 hours, it is recommended that they stop using the product and consult a healthcare professional, as these symptoms may indicate a serious condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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.

Packaging configurations for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%.
Details

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 or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration. It is advisable to consider dose adjustments and to ensure that appropriate safety measures are in place to mitigate risks associated with this demographic. Regular assessment of the patient's response to treatment is recommended to ensure optimal safety and efficacy.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in premature infants or infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be caring for infants in the specified age group.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management of overdose may involve the use of specific antidotes, if available, and symptomatic treatment tailored to the patient's needs. Continuous monitoring and supportive measures should be implemented until the patient is stabilized.

In all cases of suspected overdose, consultation with a poison control center or toxicology expert is advised to ensure appropriate management and intervention strategies are employed.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including severe allergic reactions. These may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they have a known allergy to chlorhexidine gluconate or any other ingredient in the formulation. It is crucial to emphasize that this product should not be used as a 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.

Patients should be instructed to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these symptoms 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 case of contact with these areas, patients should rinse with cold water immediately.

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 be avoided 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 controlled temperature between 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically. Clinicians should exercise caution when prescribing this treatment to premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients and caregivers should be advised to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

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.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Maxiclens Chlorhexidine Gluconate Liquid Solution, 4%, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.