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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 2012
Label revision date
December 12, 2025
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 2012
Label revision date
December 12, 2025
Manufacturer
Cardinal Health
Registration number
NDA019125
NDC root
70000-0407
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

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser designed to help reduce bacteria on the skin that can potentially cause disease. It is commonly used for hand hygiene by healthcare personnel, as well as for cleansing skin wounds and general skin care. This solution is intended for external use only and is effective in promoting cleanliness and preventing infections.

Uses

You can use this product for a couple of important 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 crucial for maintaining hygiene, especially in medical settings.

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, ensuring that the area stays clean and helps prevent infection. Overall, this product is a helpful tool for promoting cleanliness and health.

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 any area of your skin, begin by rinsing the area with water. Next, apply just enough of the product to cover the skin or wound gently. After washing, make sure to 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 complications. If you have any concerns or questions about using this product, please consult your healthcare provider.

Side Effects

This product is for external use only. It may cause a severe allergic reaction in some individuals. Symptoms of such a 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.

You should also stop using the product and consult a doctor if you notice any irritation, sensitization, or signs of an allergic reaction, as these could indicate a more serious condition.

Warnings and Precautions

This product is 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.

You should also stop using this product and consult your doctor if you notice any irritation, sensitization, or signs of an allergic reaction, as these could indicate a more serious condition. If the product is swallowed, it’s important to get 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 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 that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

The safety of chlorhexidine gluconate during pregnancy has not been established, which means that its effects on you and your developing baby are not fully known. Because of potential risks to the fetus, it is advised that you avoid using chlorhexidine gluconate while pregnant.

If you are considering using this product or have any questions about its use during pregnancy, it is important to consult your healthcare provider first. They can provide guidance tailored to your specific situation and help ensure the safety of both you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using certain medications. Specifically, if your infant is premature or under 2 months old, you should use these products carefully, as they may cause irritation or even chemical burns in young infants. Always consult with your healthcare provider to ensure the safety of any medication you consider while nursing. Your baby's health is the top priority, so taking these precautions can help protect them during this sensitive time.

Pediatric Use

When using this medication for children, especially for premature infants or those under 2 months old, it's important to be cautious. These young ones may be more sensitive, and the product could potentially cause irritation or chemical burns.

Always keep the medication 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 ensure their safety.

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 the safety and appropriateness of any treatment, particularly for those who may have specific health concerns or sensitivities. Your healthcare provider can help guide you in making the best choices for the health and well-being of older adults and young infants alike.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25 ºC (68-77 ºF). It's important to avoid exposing it to excessive heat, particularly temperatures around 40 ºC (104 ºF), as this can compromise its effectiveness.

When handling the product, always do so with care to maintain its integrity. If you have any specific components that come with the product, make sure to follow any additional instructions provided for their use and safety. Proper storage and handling will help you get the most out of your device.

Additional Information

No further information is available.

FAQ

What is Chlorhexidine Gluconate 4% Solution used for?

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial 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 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. Rinse thoroughly with water if contact occurs.

Are there any contraindications for using Chlorhexidine Gluconate?

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

What should I do if I experience an allergic reaction?

If you experience symptoms like wheezing, facial swelling, or hives, stop using the product and seek medical help immediately.

Is Chlorhexidine Gluconate safe to use during pregnancy?

The safety of Chlorhexidine Gluconate during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if Chlorhexidine Gluconate 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 ºC (68-77 ºF) and avoid excessive heat above 40 ºC (104 ºF).

Packaging Info

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate). 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

No description information is available for the drug.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that may potentially cause disease. It is also indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Healthcare personnel should initiate hand hygiene by wetting hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for a duration of about 15 seconds. It is essential to rinse hands thoroughly and dry them completely.

For skin wound and general skin cleansing, the area to be cleaned must 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 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.

Monitoring for signs of irritation, sensitization, or any allergic reaction is essential. Should any of these symptoms manifest, the healthcare provider should advise the patient to stop using the product and consult a physician, as these may indicate a serious condition.

In cases of accidental ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center without delay. Prompt action is necessary to ensure patient safety and appropriate management of the situation.

Side Effects

Patients using this product should be aware that it is for external use only. There is a potential 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, patients are advised to discontinue use immediately and seek medical assistance.

Additionally, patients should 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 currently no documented drug interactions associated with this medication. Additionally, there are no known 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). 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 due to the potential risk of 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. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. Due to potential risks to the fetus, chlorhexidine gluconate is contraindicated in pregnancy. Use during this period should be approached with caution, and it is recommended that pregnant patients consult a healthcare provider before use.

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 reactions when the mother is using this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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 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 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. They must be instructed to discontinue use and consult a healthcare provider if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

When using this product, patients should be reminded to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if the solution is instilled in the middle ear through perforated eardrums. In the event of contact with these 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 if specifically advised by a healthcare provider.

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 room temperature of 20-25 ºC (68-77 ºF). Care should be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40 ºC (104 ºF), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety 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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Primary FDA sources:

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.