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Antiseptic Skin Cleanser

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Active ingredient
Chlorhexidine Gluconate 4 mg/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 2013
Label revision date
December 12, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 4 mg/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 2013
Label revision date
December 12, 2025
Manufacturer
AmerisourceBergen Drug Corporation
Registration number
NDA019125
NDC root
46122-137
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 available in two sizes: 8 FL OZ (237 mL) and 16 FL OZ (473 mL). This product is intended for external use only and is dye-free, making it suitable for a variety of skin types.

When using this cleanser, you can feel confident that it is working to keep your skin clean and reduce the risk of infections. Always ensure that the safety seal is intact before use to guarantee its effectiveness.

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, as well as for everyday skin care. Overall, it plays a significant role in promoting cleanliness and preventing infections.

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 5ml 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 normal skin, 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 is 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 is crucial to ensure your safety and well-being. If you have any concerns or questions about using this product, please consult with a healthcare professional.

Side Effects

This product may cause severe allergic reactions, which can include symptoms like 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. You should not use 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, avoid contact with your eyes, ears, and mouth, as it can cause serious injuries, including permanent eye damage or deafness if it enters the ear. If the solution does come into contact with these areas, rinse thoroughly with water. Additionally, do not use it on deep wounds or perform repeated cleansing of large skin areas unless directed by a healthcare provider. If you notice any irritation, sensitization, or allergic reactions, stop use and consult your doctor.

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. Avoid using it near the meninges (the protective membranes covering the brain and spinal cord) or in the genital area. If you accidentally swallow the product, get medical help or contact a Poison Control Center right away.

If you notice any irritation, sensitization, or signs of an allergic reaction, stop using the product and call your doctor, as these could indicate a serious condition.

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 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

The safety of chlorhexidine gluconate during pregnancy has not been established, meaning there isn't enough information to confirm whether it is safe for you or your developing baby. While there are no specific contraindications (reasons not to use it) or dosage modifications mentioned for pregnant individuals, it's important to be cautious since there is no detailed information about potential risks to the fetus.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including chlorhexidine gluconate, to ensure it is appropriate for your situation.

Lactation Use

When 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 even 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. Your health and your baby's well-being are the top priorities.

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 safety and appropriate use.

If you or your loved one falls into this category, make sure to discuss any concerns with your doctor, who can provide guidance tailored to your specific needs.

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 may affect you if your kidneys are not functioning properly.

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 help monitor your condition and make any necessary adjustments to your treatment plan.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance and safety 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 40° C (104° F).

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

Additional Information

No further information is available.

FAQ

What is the active ingredient in Antiseptic Skin Cleanser?

The active ingredient in Antiseptic Skin Cleanser is chlorhexidine gluconate 4% solution.

What are the available sizes of Antiseptic Skin Cleanser?

Antiseptic Skin Cleanser is available in 8 FL OZ (237 mL) and 16 FL OZ (473 mL) sizes.

What is the primary use of Antiseptic Skin Cleanser?

It is used for healthcare personnel handwashing and for skin wound and general skin cleansing.

How should I use Antiseptic Skin Cleanser for handwashing?

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

Are there any contraindications for using Antiseptic Skin Cleanser?

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

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, stop use and seek medical help right away.

Is Antiseptic Skin Cleanser safe to use during pregnancy?

The safety of chlorhexidine gluconate during pregnancy has not been established, and there are no specific contraindications mentioned.

What precautions should I take when using Antiseptic Skin Cleanser?

Keep it out of eyes, ears, and mouth, and do not use on wounds that involve more than the superficial layers of skin.

How should I store Antiseptic Skin Cleanser?

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

What should I do if Antiseptic Skin Cleanser is swallowed?

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

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

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 potentially can 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 begin by wetting their 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. After washing, hands must be rinsed thoroughly and dried completely.

For skin wound and normal 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

For external use only. This product carries a significant risk of severe allergic reactions. Healthcare professionals should be vigilant for symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

It is crucial to ensure that neither the patient nor the healthcare provider has a known allergy to chlorhexidine gluconate or any other component of this product prior to administration. The product should not be applied in contact with the meninges or used in the genital area, as these applications may pose additional risks.

In cases of ingestion, immediate medical attention is required. Healthcare professionals should advise patients to seek emergency medical help or contact a Poison Control Center without delay.

If any signs of irritation, sensitization, or allergic reaction occur during use, it is essential to stop the application and consult a physician, as these symptoms may indicate a serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Notably, there is a potential for 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 the patient discontinue use immediately and seek medical assistance.

Participants should be advised against using this product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained within. Additionally, the product should not be applied in contact with the meninges or in the genital area.

Patients are also cautioned to stop use and consult a healthcare provider if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

While using this product, it is essential 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. Should the solution come into contact with these areas, it is crucial to rinse thoroughly with water. Furthermore, 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.

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 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 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.

Healthcare providers are advised to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with the use of this medication in the elderly population.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. There are no specific contraindications for its use during pregnancy, and no information regarding risk to the fetus is provided. Additionally, no dosage modifications for pregnant individuals are mentioned, nor are there any special precautions specified regarding its use during this period. Healthcare professionals should consider these factors when advising pregnant patients or women of childbearing potential.

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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data may necessitate individualized assessment and monitoring based on the patient's overall clinical status.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented as necessary to ensure patient safety and recovery.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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.

Providers should emphasize that the product should not be used in contact with the meninges or in the genital area. Patients must be instructed to discontinue use and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, healthcare providers should remind patients 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. In the event of contact with these areas, patients should rinse thoroughly and promptly with water.

Providers should also counsel 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.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 20° to 25° C (68° to 77° F). Care should be taken to avoid exposure to excessive heat, specifically temperatures above 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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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.