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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
November 6, 2023
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
November 6, 2023
Manufacturer
Rite Aid Corporation
Registration number
NDA019125
NDC root
11822-3678
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Chlorhexidine Gluconate is a 4% antiseptic and antimicrobial solution used primarily as a skin cleanser. It is designed for external use only and helps reduce bacteria on the skin that can potentially cause disease. This makes it particularly useful for healthcare personnel during handwashing and for general skin cleansing, including cleaning skin wounds.

This dye-free solution comes in an 8 FL OZ (237 mL) bottle and is an effective option for maintaining skin hygiene. If you are considering using it, be sure to check that the packaging is intact before use.

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 is free from dirt and bacteria, which can help prevent infections.

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 handwashing product into your cupped hands and scrub vigorously for about 15 seconds. After that, rinse your hands thoroughly and dry them completely. For optimal cleanliness, repeat this handwashing process for an additional 2 minutes, and finish by drying your hands with a sterile towel.

When it comes to cleaning skin wounds or normal skin, begin by thoroughly rinsing the area with water. Next, apply just enough of the cleansing product to cover the skin or wound area, and wash gently. Finally, rinse the area again thoroughly to ensure all 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. 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 your healthcare provider.

Side Effects

This product is for external use only and may cause severe allergic reactions in some individuals. 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.

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. If you notice any irritation, sensitization, or signs of an allergic reaction while using the product, stop use and consult a doctor. Additionally, be cautious to avoid contact with your eyes, ears, and mouth, as this can lead to serious injuries. If the solution accidentally gets into these areas, rinse thoroughly with water.

Warnings and Precautions

This product is for external use only, and you should be aware of the potential for severe allergic reactions. Symptoms of an allergic reaction may include 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. Additionally, if the product is swallowed, contact a Poison Control Center or seek medical assistance right away.

While using this product, avoid contact with your eyes, ears, and mouth, as it can cause serious and permanent damage if it enters these areas. If contact occurs, rinse thoroughly with water. Do not use this product on deep wounds or large areas of skin unless directed by a healthcare provider. If you notice any irritation, sensitization, or allergic reactions, stop using the product and consult your doctor, as these may indicate a more serious condition.

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 get checked by a medical professional.

Pregnancy Use

When it comes to using this medication during pregnancy, there are no specific safety concerns or special precautions mentioned. Additionally, there are no dosage modifications required for pregnant individuals. However, since the information provided does not explicitly address pregnancy use, it's always best to consult with your healthcare provider before starting any new medication if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and circumstances.

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 using this medication in older adults, it's important to proceed with caution. Elderly patients may be more sensitive to side effects, so you should be vigilant for any signs of irritation, sensitization, or allergic reactions. These symptoms could indicate a more serious condition, which may require immediate attention.

While there are no specific dosage adjustments for older adults, monitoring their response to the medication is crucial. Keeping an eye on how they react can help ensure their safety and well-being. Always consult with a healthcare provider if you have any concerns or notice any unusual symptoms.

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 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 should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

Drug Interactions

It's important to be aware that using chlorhexidine gluconate skin cleansers alongside chlorine-releasing products, like bleach, can lead to staining. This interaction can affect the appearance of your skin and any surfaces that come into contact with these substances.

To ensure your safety and the effectiveness of your treatments, always discuss any medications or products you are using with your healthcare provider. They can help you understand potential interactions and guide you on the best practices for your health.

Storage and Handling

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

When handling the device, always do so with care to maintain its integrity and effectiveness. Following these storage and handling guidelines will help ensure your product remains safe and functional for use.

Additional Information

No further information is available.

FAQ

What is Chlorhexidine Gluconate?

Chlorhexidine Gluconate is a 4% antiseptic and antimicrobial skin cleanser that is dye-free and for external use only.

What are the main uses of Chlorhexidine Gluconate?

It is used for healthcare personnel handwashing to reduce bacteria that can cause disease and for skin wound and general skin cleansing.

How should I use Chlorhexidine Gluconate for handwashing?

Wet your hands with water, dispense about 5 mL of the product, wash vigorously for 15 seconds, rinse, and dry thoroughly. Repeat for an additional 2 minutes.

What should I do if I experience an allergic reaction?

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 Chlorhexidine Gluconate?

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.

Can Chlorhexidine Gluconate be used during pregnancy?

The provided information does not specify any precautions or dosage modifications for use during pregnancy.

What should I do if I swallow Chlorhexidine Gluconate?

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

How should Chlorhexidine Gluconate be stored?

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

Chlorhexidine Gluconate 4% Solution is an antiseptic and antimicrobial skin cleanser, comparable to the active ingredient in Hibiclens®. This formulation is presented in a dye-free solution, specifically designed for external use only. The product is packaged in an 8 fluid ounce (237 mL) container. It is important to note that the product features a tamper-evident seal; it should not be used if the shrink seal neckband is broken or missing. The National Drug Code (NDC) for this product is 11822-3678-8.

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 and general skin cleansing.

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

Dosage and Administration

Healthcare personnel should initiate handwashing 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. After this initial wash, hands must be rinsed thoroughly and dried. This procedure should be repeated for an additional 2 minutes, concluding with drying using a sterile towel.

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. A thorough rinse is required to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this formulation should not use this product due to the risk of severe allergic reactions.

Contact with the meninges is contraindicated, as it may lead to serious complications.

Additionally, the product should not be applied in the genital area to avoid potential adverse effects.

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 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.

In cases where the product is ingested, prompt medical attention should be sought, or the local Poison Control Center should be contacted without delay. Users should also be advised to stop using the product and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

When administering this product, it is crucial to avoid contact with the eyes, ears, and mouth. Exposure to these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled into the middle ear through perforated eardrums. Should the solution come into contact with these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Healthcare providers should exercise caution when treating wounds that extend beyond the superficial layers of the skin, as routine treatment of such wounds is not recommended. Additionally, repeated general skin cleansing of large body areas should only be performed under the guidance of a healthcare professional.

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions. The product is for external use only and may cause severe allergic reactions in some individuals. Symptoms of such reactions can include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

It is contraindicated for use in patients who are allergic to chlorhexidine gluconate or any other ingredient in the formulation. Additionally, the product should not be applied in contact with the meninges or in the genital area.

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.

While 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 should be rinsed out promptly and 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

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including bleach, resulting in staining. It is advisable to avoid the concurrent use of these agents to prevent discoloration of the skin or surfaces. No specific dosage adjustments or monitoring parameters are indicated for this interaction; however, caution is recommended when using these products in combination.

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 may exhibit increased sensitivity to side effects, necessitating careful consideration when prescribing this medication. Although no specific dosage adjustments are recommended for geriatric use, it is essential for healthcare providers to monitor these patients closely.

Particular attention should be given to signs of irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition in elderly patients. Regular assessment and vigilance are advised to ensure the safety and well-being of this population.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or special precautions associated with the use of this medication during pregnancy. Additionally, there are no dosage modifications indicated for pregnant individuals. While the prescribing information does not provide explicit data regarding the effects on fetal outcomes, healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential. It is advisable for healthcare providers to engage in shared decision-making with their patients regarding the use of this medication during pregnancy.

Lactation

Lactating mothers should use this product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. There is limited data on the excretion of this product in breast milk and its effects on breastfed infants. Therefore, healthcare professionals are advised to consider the potential risks and benefits when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified cases of severe allergic reactions associated with the use of chlorhexidine gluconate. Reported symptoms include wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been documented, which may indicate a serious condition. These events were reported voluntarily or through surveillance programs.

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 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 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 when 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 temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), 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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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.