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Antiseptic Skin Cleanser

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Active ingredient
Chlorhexidine Gluconate 4 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2011
Label revision date
March 3, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 4 g/100 mL
Other brand names
Dosage form
Liquid
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 2011
Label revision date
March 3, 2026
Manufacturer
Xttrium Laboratories, Inc.
Registration number
NDA019125
NDC root
0116-0767
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

Drug Overview

Chlorhexidine Gluconate 4% Solution is an antiseptic skin cleanser designed to help reduce bacteria on the skin that can potentially cause disease. It is clinically proven to be effective as an antimicrobial agent, making it a reliable choice for maintaining skin hygiene.

This solution is intended for external use only and is commonly compared to the active ingredient found in Hibiclens®, another well-known antiseptic product. By using Chlorhexidine Gluconate, you can help ensure that your skin is clean and less prone to infections.

Uses

You can use this product for two main purposes. First, it is effective for healthcare personnel handwashing, helping to reduce the number of bacteria on your hands that could potentially cause disease. This is especially important in settings where hygiene is crucial to prevent infections.

Additionally, it is suitable for cleansing skin wounds and for general skin cleansing. This means you can use it to clean minor cuts or scrapes, as well as for everyday skin hygiene.

Dosage and Administration

To ensure proper hygiene, it's important to wash your hands correctly. Start by wetting your hands with water. Then, dispense about 5 ml of the product into your cupped hands and scrub them vigorously for about 15 seconds. After that, rinse your hands thoroughly and dry them completely.

If you need to clean a skin wound or just your skin in general, begin by rinsing the area with water. Next, apply just enough of the product to cover the skin or wound, and wash it gently. Finally, rinse the area thoroughly again to ensure it's clean. Following these steps will help maintain good hygiene and promote healing.

What to Avoid

You should avoid using this product if you are allergic to chlorhexidine gluconate or any of its other ingredients. It's also important not to apply it in contact with the meninges (the protective membranes covering the brain and spinal cord) or in the genital area. Following these guidelines helps ensure your safety and prevents potential adverse reactions. If you have any concerns or questions about using this product, please consult with a healthcare professional.

Side Effects

This product may cause a severe allergic reaction, which can include symptoms like 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. It's important to avoid using this product if you are allergic to chlorhexidine gluconate or any of its ingredients, or if it comes into contact with the meninges (the protective membranes covering the brain and spinal cord) or the genital area.

While using this product, be careful to keep it away from your eyes, ears, and mouth, as it can cause serious injuries, including permanent eye damage or hearing loss. If the solution accidentally contacts these areas, rinse thoroughly with water. If you notice any irritation, sensitization, or signs of an allergic reaction, stop using the product and consult a doctor. Additionally, if the product is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only. Be aware that it may cause a severe allergic reaction, which can include symptoms like wheezing or difficulty breathing, shock, facial swelling, hives, or rash. If you experience any of these symptoms, stop using the product immediately and seek medical help.

If you notice any irritation, sensitization, or signs of an allergic reaction, it's important to stop using the product and consult your doctor, as these could indicate a serious condition. Additionally, if the product is swallowed, seek medical assistance or contact a Poison Control Center right away. Your safety is a priority, so please take these warnings seriously.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact a medical professional or call a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek immediate medical attention. Your safety is the top priority, so getting help quickly can make a significant difference.

Pregnancy Use

You can use chlorhexidine gluconate 4% solution during pregnancy without specific warnings or dosage changes. The information available does not suggest that this product is contraindicated (not recommended) for pregnant individuals or that it poses any risk to the developing fetus.

As always, it's a good idea to consult with your healthcare provider before using any medication or treatment during pregnancy to ensure it’s 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 younger than 2 months old. These products can potentially cause irritation or chemical burns in very young infants. Always consult with your healthcare provider before using any medication to ensure it is safe for you and your baby.

Pediatric Use

When considering this medication for your child, it's important to use it with caution, especially if your child is a premature infant or younger than 2 months old. In these cases, the medication may cause irritation or even chemical burns. Always consult with your child's healthcare provider to ensure safe use and to discuss any concerns you may have regarding their age and health status.

Geriatric Use

When considering medication for older adults, it's important to be cautious, especially if you are caring for premature infants or infants under 2 months old. These medications can potentially cause irritation or chemical burns in very young children, so extra care should be taken in these situations.

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. Your health and safety are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have 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 health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, it's essential to discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, as temperatures above 40°C (104°F) can damage the product.

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is Chlorhexidine Gluconate 4% Solution used for?

Chlorhexidine Gluconate 4% Solution is an antiseptic skin cleanser used for healthcare personnel handwashing and general skin cleansing.

How should I use Chlorhexidine Gluconate for handwashing?

Wet your hands with water, dispense about 5 ml of the product into your cupped hands, wash vigorously for about 15 seconds, then rinse and dry thoroughly.

What should I do for skin wound cleansing?

Thoroughly rinse the area with water, apply the minimum amount of product necessary to cover the area, wash gently, and rinse again thoroughly.

Are there any contraindications for using this product?

Do not use if you are allergic to chlorhexidine gluconate or any other ingredient, in contact with meninges, or in the genital area.

What should I do if I experience an allergic reaction?

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

Is Chlorhexidine Gluconate safe to use during pregnancy?

The product insert does not indicate any specific risks or contraindications for use during pregnancy.

What precautions should I take when using this product?

Keep the solution out of your eyes, ears, and mouth, as it may cause serious injury if it enters these areas.

What should I do if the product is swallowed?

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

How should I store Chlorhexidine Gluconate?

Store the product at 20-25°C (68-77°F) and avoid excessive heat above 40°C (104°F).

Packaging Info

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antiseptic Skin Cleanser.
Details

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)

Description

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser intended for external use only. It is available in the following dosage forms: 8 fl oz (237 mL), 16 fl oz (473 mL), and 18 fl oz (532 mL).

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash to help reduce bacteria that potentially can cause disease. Additionally, it is indicated for skin wound and general skin cleansing.

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

Dosage and Administration

Healthcare personnel should begin by wetting their hands with water. Approximately 5 ml of the product should be dispensed into cupped hands, followed by vigorous washing for about 15 seconds. After washing, hands must be rinsed thoroughly and dried.

For skin wound and general skin cleansing, 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. The area must be rinsed again thoroughly 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 without delay. Additionally, if any signs of irritation, sensitization, or allergic reaction occur, the healthcare provider should advise the patient to stop using the product and consult a physician, as these symptoms may signify a serious underlying condition.

In cases where the product is ingested, it is crucial to obtain medical help or contact a Poison Control Center immediately. Monitoring for these adverse effects is essential to ensure patient safety and appropriate management of any reactions that may arise.

Side Effects

This product may cause severe allergic reactions in some patients. Symptoms of an allergic reaction can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients should discontinue use immediately and seek medical assistance.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, it is contraindicated for use in contact with the meninges or in the genital area.

When using this product, it is crucial 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 advised to rinse thoroughly with water. 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 only be performed under the guidance of a healthcare provider.

Patients are advised to stop using the product and consult a doctor if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. In cases of accidental ingestion, immediate medical help should be sought, or contact with a Poison Control Center is recommended.

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 Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antiseptic Skin Cleanser.
Details

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should use this product with caution. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

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 of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The use of chlorhexidine gluconate 4% solution during pregnancy has not been associated with specific warnings, precautions, or dosage modifications. The available data does not indicate whether the product is contraindicated in pregnant patients or presents any risk to the fetus. As such, healthcare professionals should consider the benefits and potential risks when recommending this product to women of childbearing potential. Further studies may be warranted to fully understand the implications of its use during pregnancy.

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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific guidelines are not outlined.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 the potential for severe allergic reactions associated with this product. Reported symptoms of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In cases of an allergic reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition. The product should be used with caution in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

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. Providers must emphasize the importance of keeping the solution away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of contact with these sensitive 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 when specifically advised by a healthcare provider.

Patients should be instructed to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Proper storage conditions are essential 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 Antiseptic Skin Cleanser, 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 Antiseptic Skin Cleanser, 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.