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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
CVS Pharmacy, Inc.
Registration number
NDA019125
NDC root
59779-767
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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 antimicrobial skin cleanser designed for external use only. It helps reduce bacteria on the skin that can potentially cause disease, making it a useful option for maintaining skin hygiene.

This product is dye-free and is comparable to the active ingredient found in Hibiclens®. It is available in various sizes, including 8 FL OZ, 16 FL OZ, and 18 FL OZ bottles.

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 that could potentially cause disease. This is crucial in maintaining hygiene and preventing infections in healthcare settings.

Additionally, it is suitable for cleansing skin wounds and for general cleansing. This means you can use it to clean minor cuts or scrapes, ensuring that the area is free from dirt and bacteria, which can help promote healing.

Dosage and Administration

To ensure proper hygiene, it's important for healthcare personnel to wash their hands correctly. Start by wetting your hands with water. Then, dispense about 5 ml of the cleansing product into your cupped hands and wash them vigorously for 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 cleansing product to cover the skin or wound, and wash it gently. Finally, rinse the area thoroughly again to ensure all the product is removed. Following these steps will help maintain cleanliness 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. Additionally, do not apply it in areas that come into contact with the meninges (the protective membranes covering the brain and spinal cord) or in the genital area. These precautions are important to ensure your safety and prevent any adverse reactions. If you have any concerns or questions about using this product, please consult your healthcare provider.

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 deafness if it enters these areas. If contact occurs, rinse thoroughly with water. You should also stop using the product and consult a doctor if you notice any irritation, sensitization, or allergic reactions, as these could indicate a more serious issue. If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

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

Be cautious to keep the product away from your eyes, ears, and mouth, as it can cause serious and permanent damage if it gets into these areas. If contact occurs, rinse thoroughly with water right away. Avoid using this product on deep wounds or large areas of skin unless directed by a healthcare provider.

If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately. Additionally, if you notice any irritation, sensitization, or signs of an allergic reaction, stop using the product and call your doctor.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is not recommended for use in pregnant women due to potential risks to the fetus. If you have any concerns or questions, please consult your healthcare provider for personalized advice.

Additionally, there are no specific dosage modifications for pregnant women, but caution is advised. Always discuss your situation with your healthcare provider to ensure the best care 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 using this medication for children, especially in 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 even chemical burns. Always ensure that the medication 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 is key to keeping 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 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 may affect you 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 you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used in patients with liver impairment.

Before starting any new medication, including this one, you should 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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). It's important to keep it away from excessive heat, so avoid temperatures above 40°C (104°F). Proper storage helps maintain the integrity of the device and ensures it functions as intended.

When handling the product, always do so with care to prevent any damage. Make sure to follow any additional safety instructions provided with the device to ensure safe usage. If you have any questions about disposal or specific handling procedures, refer to the guidelines included with your product.

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 wound cleansing.

How does Chlorhexidine Gluconate work?

It helps reduce bacteria that can potentially cause disease.

What should I do if I have an allergic reaction to this product?

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

Are there any contraindications for using this product?

Yes, do not use it if you are allergic to chlorhexidine gluconate, in contact with meninges, or in the genital area.

What precautions should I take when using this product?

Keep it 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.

Is it safe to use during pregnancy?

Safety during pregnancy has not been established, and it is advised to consult a healthcare provider if pregnant or planning to become pregnant.

What should I do if I swallow this product?

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

How should I store Chlorhexidine Gluconate?

Store it 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

No description information is available for the drug.

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 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 15 seconds. After washing, hands must be rinsed thoroughly and dried completely.

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 areas in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area, as this may lead to irritation or other complications.

Warnings and Precautions

For external use only. This product carries a significant risk of severe allergic reactions. Symptoms indicative of such reactions may include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions must be observed to ensure safe application. The product should be kept away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly with water without delay. Additionally, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Repeated cleansing of large body areas is discouraged unless specifically recommended by a healthcare provider.

In cases of ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

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, it is imperative to 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, the product should not be applied 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 deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is essential 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 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. It is advisable to consider dose adjustments and enhanced monitoring for geriatric patients to ensure safety and efficacy.

Pregnancy

Safety during pregnancy has not been established for this medication. It is contraindicated for use in pregnant women due to potential risks to the fetus. There may be risks associated with fetal outcomes; therefore, it is essential for healthcare providers to be consulted for advice regarding the use of this medication in pregnant patients.

No specific dosage modifications are provided for pregnant women. Caution is advised, and healthcare providers should be consulted if a patient is pregnant or planning to become pregnant.

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 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 recommendations are not provided.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

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

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Similarly, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Additionally, there is no information available regarding animal pharmacology and toxicology.

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 instances of an allergic reaction, it is advised to discontinue use immediately and seek medical assistance.

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

Furthermore, it is important to note that this product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer. For further information, individuals are directed to visit www.P65Warnings.gov.

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.