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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
0404-0221
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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 that helps reduce the number of microorganisms on the skin. It is commonly used as a surgical hand scrub to significantly lower the presence of bacteria on the hands and forearms before surgery or patient care. Additionally, Maxiclens serves as a handwash for healthcare personnel, aiding in the reduction of bacteria that could potentially cause disease, and it can be used as a general skin cleanser to help keep wounds and skin clean.

This product is intended for external use only and is designed to help maintain 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 during medical procedures.

Additionally, it acts as a handwash for healthcare personnel, helping to lower the presence of bacteria that could potentially cause disease. Lastly, it can be used as a skin wound and general skin cleanser, effectively reducing bacteria on the skin to promote better hygiene and healing.

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, apply just enough product to cover the skin or wound, and wash gently. Rinse thoroughly with water, and then rinse again 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 severe allergic reactions in some individuals. If you experience symptoms such as wheezing, difficulty breathing, facial swelling, hives, or a rash, stop using the product immediately and seek medical help.

You should not use this product if you are allergic to chlorhexidine gluconate or any of its ingredients. It is also important to avoid using it as a skin preparation before surgery, especially on the head or face, and it should not 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 reactions that last for 72 hours, stop using the product and consult your doctor, as these could indicate a serious condition.

In case of accidental ingestion, seek emergency medical assistance or contact a Poison Control Center immediately.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s 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 younger than 2 months, be particularly careful, as these 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 chemical burns in this vulnerable age group.

Always consult with a healthcare professional to ensure that the medication is appropriate and safe 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 requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 is anything above 104°F (40°C), as this can compromise its effectiveness.

For any additional safety information, please refer to the Safety Data Sheet (SDS), which provides detailed guidance on handling and disposal. By following these storage and handling instructions, you can help maintain the quality and safety of your product.

Additional Information

You should use this medication topically, meaning it is applied directly to the skin. It's important to avoid contact with your eyes, ears, and mouth, as doing so can lead to serious injuries, including permanent eye damage or hearing loss if it enters the middle ear through a perforated eardrum. If contact occurs, rinse the area with cold water immediately.

If you are caring for a premature infant or an infant under 2 months old, use this product with caution, as it may cause irritation or chemical burns. Additionally, if the medication is swallowed, seek medical assistance or contact a Poison Control Center right away.

FAQ

What is Maxiclens?

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

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.

Can I use Maxiclens 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 should I do if I have an allergic reaction to Maxiclens?

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

Is Maxiclens safe for external use?

Yes, Maxiclens is for external use only, but keep it away from eyes, ears, and mouth to avoid serious injury.

What are the storage conditions for Maxiclens?

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

What should I do if Maxiclens is swallowed?

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

Can I use Maxiclens on wounds?

Yes, apply the minimum amount necessary to cover the skin or wound area, wash gently, and rinse thoroughly.

Are there any contraindications for using Maxiclens?

Do not use Maxiclens if you are allergic to chlorhexidine gluconate or if it is intended for preoperative skin preparation on the head or face.

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 should exercise caution when using this product 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 adhered to:

  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 thorough 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, followed by rinsing under running water.

  7. 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 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 not recommended due to potential irritation and adverse reactions.

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.

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 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, it is imperative that patients discontinue use immediately and seek medical assistance.

Additionally, patients should be advised to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any allergic reaction that persists for 72 hours, 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 careful consideration and caution in this demographic. It is advisable to assess the risks versus benefits before initiating treatment in these patients, ensuring that appropriate safety measures are in place.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of 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 vulnerable populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially if there is a possibility of exposure to infants.

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 considered as part of standard clinical practice.

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 significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the case effectively.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further management.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical data. Additionally, there is no information regarding animal pharmacology and toxicology. The insert does not provide any details on nonclinical toxicology, including carcinogenicity or mutagenicity.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which may include severe manifestations such 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 are allergic 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 should 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.

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

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104°F (40°C). For further details regarding safety and handling, please refer to the Safety Data Sheet (SDS).

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to avoid contact with the eyes, ears, and mouth, as serious and permanent eye injury may occur if the product is placed in the eye during surgical procedures, and deafness may result if instilled in the middle ear through perforated eardrums. In the event of contact, patients should rinse the affected area with cold water immediately.

Special caution is warranted when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients should be instructed 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.