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Aplicare Antiseptic Chlorhexidine Gluconate

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This product has been discontinued

Active ingredient
Chlorhexidine Gluconate 4 g/100 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1998
Label revision date
August 11, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 4 g/100 mL
Other brand names
Dosage form
Solution
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 1998
Label revision date
August 11, 2015
Manufacturer
Aplicare, Inc.
Registration number
NDA019125
NDC root
52380-1272
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (5 NDCs)
Packaging & NDC Codes (5)

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If you are a consumer or patient please visit this version.

Drug Overview

4% Chlorhexidine Gluconate is a type of antiseptic solution commonly used in healthcare settings. It serves multiple purposes, including as a surgical hand scrub to significantly reduce the number of microorganisms on the hands and forearms before surgery or patient care. Additionally, it is used for handwashing by healthcare personnel to help decrease bacteria that could potentially cause disease.

This solution is also effective for preparing a patient's skin prior to surgery and for general skin cleansing, including the care of skin wounds. By using 4% Chlorhexidine Gluconate, you can help ensure a cleaner and safer environment for medical procedures.

Uses

You can use this product for several important purposes related to hygiene and infection control. First, it serves as a surgical hand scrub, effectively reducing the number of microorganisms on your hands and forearms before surgery or when providing patient care. This is crucial for preventing infections during medical procedures.

Additionally, it is suitable for healthcare personnel handwashing, helping to lower the presence of bacteria that could lead to disease. If you're preparing for surgery, this product can also be used for patient preoperative skin preparation, ensuring the skin is clean and ready for the procedure. Lastly, it is effective for general skin cleansing and treating skin wounds, promoting overall skin health.

Dosage and Administration

To ensure proper hygiene before surgery or when caring for wounds, follow these simple steps. For a surgical hand scrub, start by wetting your hands and forearms with water. Use about 5 mL of the product along with a wet brush to scrub for 3 minutes, paying special attention to your nails, cuticles, and the spaces between your fingers. You can use a separate nail cleaner if needed. After scrubbing, rinse thoroughly, then wash again for another 3 minutes with 5 mL of the product, rinsing under running water. Finally, dry your hands and forearms completely.

If you are healthcare personnel performing a handwash, wet your hands first, then dispense about 5 mL of the product into your cupped hands. Wash vigorously for 15 seconds, then rinse and dry your hands thoroughly.

For preparing a patient’s skin before surgery, apply the product generously to the surgical site and swab for at least 2 minutes, then dry the area with a sterile towel. Repeat this process for another 2 minutes and dry again with a sterile towel. When cleansing a skin wound or for general skin cleaning, rinse the area with water first, then apply just enough product to cover the skin or wound, washing gently. Rinse thoroughly once more to ensure cleanliness.

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), in the genital area, or as a preoperative skin preparation on the head or face.

Using this product in these situations can lead to serious complications, so please follow these guidelines carefully to ensure your safety. If you have any questions or concerns, consult your healthcare provider for more information.

Side Effects

You should be aware that this product is for external use only and should not be used if you are allergic to chlorhexidine gluconate or any of its ingredients. Avoid using it in the genital area, on the head or face as a preoperative skin preparation, or in contact with the meninges (the protective membranes covering the brain and spinal cord).

While using this product, it is important to use it only once for patient preoperative skin preparation and 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 the solution does come into contact with your eyes, ears, or mouth, rinse thoroughly with water. Additionally, do not use it on deep wounds or for repeated cleansing of large skin areas unless necessary for a medical condition. If you experience irritation, sensitization, or an allergic reaction, stop using the product and consult a doctor, as these may indicate a serious issue.

Warnings and Precautions

This product is for external use only. Do not use it if you are allergic to chlorhexidine gluconate or any of its ingredients. Avoid using it in the genital area, on the head or face before surgery, or in contact with the meninges (the protective membranes covering the brain and spinal cord). When using this product, it is important to use it only once for patient preoperative skin preparation and to keep it away from your eyes, ears, and mouth, as it can cause serious injuries if it comes into contact with these areas. If the solution accidentally touches your eyes, ears, or mouth, rinse thoroughly with water.

If you experience any irritation, sensitization, or allergic reactions while using this product, stop using it and consult your doctor, as these could indicate a serious condition. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Center immediately.

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 guidelines or safety concerns mentioned. This means that there are no known risks or necessary dosage adjustments for pregnant individuals. However, it’s always important to consult with your healthcare provider before starting any new medication while you are pregnant or planning to become pregnant. They can provide personalized advice based on your health and circumstances.

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 nursing 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 it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always inform your doctor about all the medications, supplements, and over-the-counter products you use. This helps them monitor your health effectively and make informed decisions about your treatment plan. Your safety and well-being are the top priority, so don't hesitate to ask questions or express any concerns you may have.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically, meaning it is meant to be applied directly to the skin. It's important to use it with caution, especially on premature infants or infants younger than 2 months, as it can cause irritation or even chemical burns. Always follow your healthcare provider's instructions for safe use.

FAQ

What is 4% Chlorhexidine Gluconate used for?

4% Chlorhexidine Gluconate is used as a surgical hand scrub, healthcare personnel handwash, patient preoperative skin preparation, and for skin wound and general skin cleansing.

How do I use 4% Chlorhexidine Gluconate as a surgical hand scrub?

Wet your hands and forearms, scrub for 3 minutes with about 5 mL of product using a wet brush, paying attention to nails and cuticles, rinse, then wash for an additional 3 minutes and rinse again.

Are there any contraindications for using this product?

Do not use if you are allergic to chlorhexidine gluconate, in contact with meninges, in the genital area, or as a preoperative skin prep of the head or face.

What should I do if the solution contacts my eyes or ears?

If the solution contacts your eyes or ears, rinse out promptly and thoroughly with water to avoid serious injury.

Can I use this product on infants?

Use with care on premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.

What should I do if I experience irritation or an allergic reaction?

Stop using the product and ask a doctor if you experience irritation, sensitization, or an allergic reaction, as these may indicate a serious condition.

How should I store 4% Chlorhexidine Gluconate?

Store at room temperature, protect from light, do not freeze, and discard after opening.

Is 4% Chlorhexidine Gluconate safe to use during pregnancy?

The product does not have specific information regarding safety concerns during pregnancy, so consult your doctor before use.

Packaging Info

Below are the non-prescription pack sizes of Aplicare Antiseptic Chlorhexidine Gluconate (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aplicare Antiseptic Chlorhexidine Gluconate.
Details

Drug Information (PDF)

This file contains official product information for Aplicare Antiseptic Chlorhexidine Gluconate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Chlorhexidine Gluconate is a bisbiguanide antiseptic with a concentration of 4%. It is commonly utilized for its antimicrobial properties in various medical and dental applications. Chlorhexidine Gluconate exhibits a broad spectrum of activity against gram-positive and gram-negative bacteria, as well as some viruses and fungi. The compound is typically formulated in aqueous solutions for topical use.

Uses and Indications

This drug is indicated for surgical hand scrubs, significantly reducing the number of microorganisms on the hands and forearms prior to surgery or patient care. It is also indicated for healthcare personnel handwashing, aiding in the reduction of bacteria that may potentially cause disease. Additionally, this drug is utilized for patient preoperative skin preparation, ensuring the patient's skin is adequately prepared prior to surgical procedures. Furthermore, it is indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the healthcare professional to first wet their hands and forearms with water. Approximately 5 mL of the product should be used with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. The process should be repeated with an additional 5 mL of product for another 3 minutes, followed by rinsing under running water. It is essential to dry the hands and forearms thoroughly after completion.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense about 5 mL of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, followed by thorough rinsing and drying of the hands.

In the context of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel to ensure optimal preparation.

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. A thorough rinse is required once again to complete the cleansing process.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other components of the 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.

Application in the genital area is contraindicated to prevent potential adverse effects.

Additionally, the product should not be used as a preoperative skin preparation for the head or face to avoid complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other components of the formulation. It should not be applied in contact with the meninges, the genital area, or used as a preoperative skin preparation for the head or face.

When utilizing this product, it is essential to adhere to the following precautions. The product is intended for single use when employed for patient preoperative skin preparation. Care must be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or potential deafness if introduced into the middle ear through perforated eardrums. In the event of contact with these sensitive areas, it is imperative to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Additionally, repeated general skin cleansing of large body areas is discouraged unless necessitated by an underlying condition that requires a reduction in the bacterial population of the skin.

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 condition. In cases of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, the product should not be applied in contact with the meninges, in the genital area, or used as a preoperative skin preparation for the head or face.

During use, it is critical to adhere to specific precautions. The product is intended for single use when utilized for patient preoperative skin preparation. Care must be taken to avoid contact with the eyes, ears, and mouth, as exposure to 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 and promptly with water.

Furthermore, the product should not be used on wounds that extend beyond the superficial layers of the skin, and repeated general skin cleansing of large body areas is discouraged unless necessary to reduce the bacterial population due to an underlying condition.

Patients are advised to discontinue use and consult a healthcare professional if they experience irritation, sensitization, or any allergic reaction, as these may indicate a serious condition.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Aplicare Antiseptic Chlorhexidine Gluconate (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aplicare Antiseptic Chlorhexidine Gluconate.
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 may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or dosage modifications indicated for the use of this medication during pregnancy. Additionally, there are no special precautions outlined for pregnant individuals. As with any medication, healthcare professionals are encouraged to weigh the potential benefits against any risks when considering treatment options for pregnant patients. It is advisable for women of childbearing potential to discuss their pregnancy status and any potential implications with their healthcare provider prior to initiating therapy.

Lactation

Lactating mothers should use this product with caution when nursing premature infants or infants under 2 months of age, as there is a potential risk of irritation or chemical burns in this vulnerable population. It is important for healthcare professionals to consider these risks when advising lactating mothers regarding the use of this product.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of 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 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 a medical professional 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 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 the following adverse reactions reported voluntarily or through surveillance programs: irritation, sensitization, and allergic reactions. These reactions may be indicative of a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, patients should seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this product if they are allergic to chlorhexidine gluconate or any other ingredients contained within. It is crucial to emphasize that this product should not be used in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

Healthcare providers should instruct patients to stop using the product and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, it is important to note that it is intended for single use when utilized for patient preoperative skin preparation. Patients should be cautioned to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Additionally, patients should be advised that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population of the skin due to an underlying condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should exercise caution when using this product on premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Aplicare Antiseptic Chlorhexidine Gluconate, 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 Aplicare Antiseptic Chlorhexidine Gluconate, 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.