ADD CONDITION
Antiseptic Skin Cleanser
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- Active ingredient
- Chlorhexidine Gluconate 4 mg/100 mL
- Other brand names
- Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Antimicrobial Skin Cleanser (by Gojo Industries, Inc.)
- Antiseptic Foam Handwash (by Gojo Industries, Inc.)
- Antiseptic Skin Cleanser (by Amerisourcebergen Drug Corporation)
- Antiseptic Skin Cleanser (by Amerisourcebergen Drug Corporation)
- Antiseptic Skin Cleanser (by Ava, Inc.)
- Antiseptic Skin Cleanser (by Ava, Inc.)
- Antiseptic Skin Cleanser (by Cardinal Health)
- Antiseptic Skin Cleanser (by Chain Drug Consortium, Llc)
- Antiseptic Skin Cleanser (by Cvs Pharmacy, Inc.)
- Antiseptic Skin Cleanser (by Henry Schein, Inc.)
- Antiseptic Skin Cleanser (by Mckesson Medical-Surgical)
- Antiseptic Skin Cleanser (by Meijer Distribution, Inc.)
- Antiseptic Skin Cleanser (by Rite Aid Corporation)
- Antiseptic Skin Cleanser (by Rite Aid)
- Antiseptic Skin Cleanser (by Rite Aid)
- Antiseptic Skin Cleanser (by Strategic Sourcing Services, Llc)
- Antiseptic Skin Cleanser (by Strategic Sourcing Services, Llc)
- Antiseptic Skin Cleanser (by Topco Associates Llc)
- Antiseptic Skin Cleanser (by Walgreen Co.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Solution (by Coloplast Corp)
- Aplicare Antiseptic Chlorhexidine Gluconate (by Aplicare, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub (by Becton Dickinson and Company)
- Bd E-Z Scrub (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub 107 (by Becton Dickinson and Company)
- Betasept (by Atlantis Consumer Healthcare, Inc.)
- Cardinal Health (by Cardinal Health)
- Cardinal Health (by Xttrium Laboratories, Inc.)
- Cardinal Health Antiseptic Skin Cleanser (by Cardinal Health)
- Cardinal Health Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Mckesson)
- Chlorhexidine Gluconate (by Rising Pharma Holdings, Inc.)
- Chlorhexidine Gluconate (by Sage Products Llc)
- Chlorhexidine Gluconate Solution 0.75% Antiseptic (by Bajaj Medical, Llc)
- Chlorhexidine Gluconate Solution 0.75% Antiseptic (by Usa Medical Supply Llc)
- Cliniclean (by Hr Pharmaceuticals, Inc.)
- Cliniclean (by Hr Pharmaceuticals, Inc.)
- Cliniclean (by Xttrium Laboratories, Inc.)
- Cliniclean (by Xttrium Laboratories, Inc.)
- Dr. Dean (by Usa Medical Supply Llc)
- Dr. Dean (by Usa Medical Supply Llc)
- Dyna-Hex (by Xttrium Laboratories, Inc.)
- Dyna-Hex (by Xttrium Laboratories, Inc.)
- Dyna-Hex 2 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 2 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 4 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 4 (by Xttrium Laboratories, Inc.)
- Foaming Hand Wash (by Medline Industries, Lp)
- Foster and Thrive (by Mckesson Corporation)
- Foster and Thrive (by Xttrium Laboratories, Inc.)
- Halyard Chlorhexidine Gluconate (by Owens & Minor, Inc.)
- Halyard Chlorhexidine Gluconate (by Owens & Minor, Inc.)
- Hibiclens (by Asclemed Usa, Inc.)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens for Georgia Pacific (by Georgia-Pacific Consumer Products Lp)
- Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (by Henry Schein, Inc.)
- Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (by Henry Schein, Inc.)
- Peridex (by Solventum Us Llc)
- Provon Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Provon Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Provon Antimicrobial Foam Handwash (by Xttrium Laboratories, Inc.)
- Purell Antimicrobial Foam (by Gojo Industries, Inc.)
- Purell Antimicrobial Foam (by Gojo Industries, Inc.)
- Purell Cs Foam Handwash 2% Chg (by Gojo Industries, Inc.)
- Readyprep Chg (by Medline Industries, Lp)
- Scrub (by Bajaj Medical, Llc)
- Scrub Care (by Xttrium Laboratories, Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- View full label-group details →
- 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 2014
- Label revision date
- December 12, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Chlorhexidine Gluconate 4 mg/100 mL
- Other brand names
- Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Antimicrobial Skin Cleanser (by Gojo Industries, Inc.)
- Antiseptic Foam Handwash (by Gojo Industries, Inc.)
- Antiseptic Skin Cleanser (by Amerisourcebergen Drug Corporation)
- Antiseptic Skin Cleanser (by Amerisourcebergen Drug Corporation)
- Antiseptic Skin Cleanser (by Ava, Inc.)
- Antiseptic Skin Cleanser (by Ava, Inc.)
- Antiseptic Skin Cleanser (by Cardinal Health)
- Antiseptic Skin Cleanser (by Chain Drug Consortium, Llc)
- Antiseptic Skin Cleanser (by Cvs Pharmacy, Inc.)
- Antiseptic Skin Cleanser (by Henry Schein, Inc.)
- Antiseptic Skin Cleanser (by Mckesson Medical-Surgical)
- Antiseptic Skin Cleanser (by Meijer Distribution, Inc.)
- Antiseptic Skin Cleanser (by Rite Aid Corporation)
- Antiseptic Skin Cleanser (by Rite Aid)
- Antiseptic Skin Cleanser (by Rite Aid)
- Antiseptic Skin Cleanser (by Strategic Sourcing Services, Llc)
- Antiseptic Skin Cleanser (by Strategic Sourcing Services, Llc)
- Antiseptic Skin Cleanser (by Topco Associates Llc)
- Antiseptic Skin Cleanser (by Walgreen Co.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Antiseptic Solution (by Coloplast Corp)
- Aplicare Antiseptic Chlorhexidine Gluconate (by Aplicare, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by SC Johnson Professional Usa, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bactoshield Chg (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub (by Becton Dickinson and Company)
- Bd E-Z Scrub (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub (by Xttrium Laboratories, Inc.)
- Bd E-Z Scrub 107 (by Becton Dickinson and Company)
- Betasept (by Atlantis Consumer Healthcare, Inc.)
- Cardinal Health (by Cardinal Health)
- Cardinal Health (by Xttrium Laboratories, Inc.)
- Cardinal Health Antiseptic Skin Cleanser (by Cardinal Health)
- Cardinal Health Antiseptic Skin Cleanser (by Xttrium Laboratories, Inc.)
- Chlorhexidine Gluconate (by Mckesson)
- Chlorhexidine Gluconate (by Rising Pharma Holdings, Inc.)
- Chlorhexidine Gluconate (by Sage Products Llc)
- Chlorhexidine Gluconate Solution 0.75% Antiseptic (by Bajaj Medical, Llc)
- Chlorhexidine Gluconate Solution 0.75% Antiseptic (by Usa Medical Supply Llc)
- Cliniclean (by Hr Pharmaceuticals, Inc.)
- Cliniclean (by Hr Pharmaceuticals, Inc.)
- Cliniclean (by Xttrium Laboratories, Inc.)
- Cliniclean (by Xttrium Laboratories, Inc.)
- Dr. Dean (by Usa Medical Supply Llc)
- Dr. Dean (by Usa Medical Supply Llc)
- Dyna-Hex (by Xttrium Laboratories, Inc.)
- Dyna-Hex (by Xttrium Laboratories, Inc.)
- Dyna-Hex 2 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 2 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 4 (by Xttrium Laboratories, Inc.)
- Dyna-Hex 4 (by Xttrium Laboratories, Inc.)
- Foaming Hand Wash (by Medline Industries, Lp)
- Foster and Thrive (by Mckesson Corporation)
- Foster and Thrive (by Xttrium Laboratories, Inc.)
- Halyard Chlorhexidine Gluconate (by Owens & Minor, Inc.)
- Halyard Chlorhexidine Gluconate (by Owens & Minor, Inc.)
- Hibiclens (by Asclemed Usa, Inc.)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens (by Molnlycke Health Care)
- Hibiclens for Georgia Pacific (by Georgia-Pacific Consumer Products Lp)
- Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (by Henry Schein, Inc.)
- Maxiclens Chlorhexidine Gluconate Liquid Solution, 4% (by Henry Schein, Inc.)
- Peridex (by Solventum Us Llc)
- Provon Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Provon Antimicrobial Foam Handwash (by Gojo Industries, Inc.)
- Provon Antimicrobial Foam Handwash (by Xttrium Laboratories, Inc.)
- Purell Antimicrobial Foam (by Gojo Industries, Inc.)
- Purell Antimicrobial Foam (by Gojo Industries, Inc.)
- Purell Cs Foam Handwash 2% Chg (by Gojo Industries, Inc.)
- Readyprep Chg (by Medline Industries, Lp)
- Scrub (by Bajaj Medical, Llc)
- Scrub Care (by Xttrium Laboratories, Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- Scrub-Stat (by Ecolab Inc.)
- View full label-group details →
- 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 2014
- Label revision date
- December 12, 2025
- Manufacturer
- Chain Drug Marketing Association Inc.
- Registration number
- NDA019125
- NDC root
- 63868-940
- Drug Information (PDF)
- Prescribing information, PDF file
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
Quality Choice is an antiseptic skin cleanser that contains chlorhexidine gluconate (a type of medication that helps reduce bacteria on the skin). It is designed for external use only and works by decreasing the number of bacteria that can potentially cause disease, making it a useful option for maintaining skin hygiene.
This product is dye-free and comes in an 8 fluid ounce (237 mL) bottle. It is comparable to the active ingredient found in HIBICLENS®, another well-known antiseptic cleanser.
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 promote healing.
Dosage and Administration
To keep your hands clean and reduce the risk of infection, start by wetting your hands with water. Next, dispense about 5ml of the product into your cupped hands. Wash your hands vigorously for about 15 seconds, making sure to cover all areas. Afterward, 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. Then, apply just enough of the product to cover the skin or wound area, and wash it gently. Finally, rinse the area thoroughly again to ensure it’s clean. Following these steps will help maintain good hygiene and promote healing.
What to Avoid
You should avoid using this product if you are allergic to chlorhexidine gluconate or any of its other ingredients. It's also important not to apply it in contact with the meninges (the protective membranes covering the brain and spinal cord) or in the genital area. Following these guidelines helps ensure your safety and prevents potential complications. If you have any concerns or questions about using this product, please consult your healthcare provider.
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. 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.
Make sure not to 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. Additionally, 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 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
The safety of chlorhexidine gluconate during pregnancy has not been established, which means that it’s unclear whether it is safe for you and your developing baby. If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before using this product. They can help you weigh the potential benefits against any risks to your fetus, as its use is generally not recommended unless the benefits clearly outweigh the risks. Always prioritize open communication with your healthcare team regarding any medications or treatments during pregnancy.
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 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 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 even chemical burns.
Always keep this medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control center for guidance. Your vigilance is key to ensuring 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 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 should be used if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help 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 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 (liver issues).
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 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 safety and effectiveness 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 can occur if the temperature exceeds 40° C (104° F).
Before using the product, always check that the safety seal is intact. If the seal is broken or missing, do not use the product, as this could compromise its safety. Following these guidelines will help you handle the product safely and maintain its quality.
Additional Information
No further information is available.
FAQ
What is Quality Choice?
Quality Choice is an antiseptic skin cleanser containing chlorhexidine gluconate 4% solution, designed to reduce bacteria on the skin.
How should I use Quality Choice for handwashing?
Wet your hands with water, dispense about 5ml of the product into your cupped hands, wash vigorously for about 15 seconds, then rinse and dry thoroughly.
Can I use Quality Choice on skin wounds?
Yes, for skin wounds, thoroughly rinse the area with water, apply the minimum amount of product necessary, wash gently, and rinse again thoroughly.
Are there any contraindications for using Quality Choice?
Do not use Quality Choice if you are allergic to chlorhexidine gluconate or any other ingredient in the product, in contact with meninges, or in the genital area.
What should I do if I experience an allergic reaction?
If you experience symptoms like wheezing, shock, facial swelling, hives, or rash, stop using the product and seek medical help immediately.
Is Quality Choice safe to use during pregnancy?
The safety of chlorhexidine gluconate during pregnancy has not been established, so consult a healthcare provider before use if you are pregnant or planning to become pregnant.
What precautions should I take when using Quality Choice?
Keep the product out of your eyes, ears, and mouth, as it may cause serious injury. Also, use with care in premature infants or infants under 2 months of age.
How should I store Quality Choice?
Store Quality Choice at 20°-25° C (68°-77° F) and avoid excessive heat above 40° C (104° F). Do not use if the safety seal is broken or missing.
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.
Details | ||||
|---|---|---|---|---|
| Liquid | 4 mg/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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.
Description
No description information is available.
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 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 the following situations:
Patients with a known allergy to chlorhexidine gluconate or any other component of this formulation should not use this product due to the risk of severe allergic reactions.
The product must not be applied in contact with the meninges, as this may lead to serious complications.
Additionally, use in the genital area is contraindicated to prevent potential adverse effects.
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 contact a Poison Control center or seek emergency medical help 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 using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.
Severe allergic reactions have been reported, which may manifest as symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is imperative that the patient discontinue use immediately and seek medical assistance. This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained within it. Additionally, it is contraindicated for use in contact with the meninges or in the genital area.
Patients are advised to stop using the product 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 crucial 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 essential 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 is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.
Packaging & NDC
Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Liquid | 4 mg/100 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
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 careful consideration and caution in this demographic.
Healthcare providers are advised to assess the risks versus benefits when prescribing this medication to geriatric patients, ensuring that appropriate safety measures are in place to mitigate any adverse effects. Regular monitoring and dose adjustments may be required based on the individual patient's response and tolerance to the treatment.
Pregnancy
The safety of chlorhexidine gluconate during pregnancy has not been established. Use is not recommended in pregnant women unless the potential benefits outweigh the risks to the fetus. It is essential for pregnant patients or those planning to become pregnant to consult a healthcare provider before using this product to ensure appropriate risk assessment and management.
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 this product is used by 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 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 assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control center without delay.
Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by medical personnel is recommended to determine the appropriate course of action.
Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.
Nonclinical Toxicology
No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.
Postmarketing Experience
Postmarketing experience has identified reports of severe allergic reactions, including wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, cases of irritation, sensitization, or allergic reactions have been reported, 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 configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20° to 25° C (68° to 77° F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F).
Additionally, the integrity of the product must be ensured; therefore, it should not be used if the safety seal is broken or missing. Proper handling and storage conditions are critical to maintaining the product's efficacy and safety.
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.