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Skin Antisepsis, Oral Cleansing, Nasal Antisepsis
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This product has been discontinued
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- Route
- Topical
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2012
- Label revision date
- October 22, 2012
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredient
- Chlorhexidine Gluconate 500 mg
- Other brand names
- Dosage form
- Cloth
- 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 2012
- Label revision date
- October 22, 2012
- Manufacturer
- Sage Products, Inc.
- Registration number
- NDA021669
- NDC root
- 53462-008
- Drug Information (PDF)
- Prescribing information, PDF file
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Drug Overview
2% chlorhexidine gluconate cloth is a medical product designed to help reduce bacteria on the skin that can potentially lead to infections. It is commonly used to prepare the skin before surgical procedures, ensuring a cleaner environment for surgery and minimizing the risk of complications. By effectively lowering the number of harmful bacteria, this cloth plays an important role in maintaining hygiene and promoting safety in medical settings.
Uses
This medication is designed to help reduce bacteria on your skin that could lead to infections. By lowering the number of these harmful bacteria, it plays a crucial role in keeping your skin healthy.
Additionally, it is used to prepare your skin before surgery. This preparation is important to minimize the risk of infection during and after the surgical procedure, ensuring a safer experience for you.
Dosage and Administration
When using the 2% Chlorhexidine Gluconate Cloth, it's important to handle it carefully, especially if you're using it on premature infants or babies under 2 months old, as it can cause irritation or chemical burns. To prepare the cloth, open the package by holding the top with one hand and lifting the flap on the back with the other. Pull down the flap to expose the cloths while ensuring that the cloths do not touch the outside of the package to avoid contamination.
For dry surgical sites, like the abdomen or arm, use one cloth to scrub a 5 x 5 inch area for 3 minutes, making sure to wet the entire area. Afterward, let it air dry for one minute without rinsing. For moist surgical sites, such as the inguinal fold, use one cloth for a smaller 2 x 5 inch area, following the same scrubbing and drying instructions. Remember to discard each cloth after a single use and any unused cloths after opening the package.
If you're applying the 3M Skin and Nasal Antiseptic, start with clean, dry skin. Dip a swab into the solution and stir it for 10 seconds, then scrub the prep site for 2 minutes, using both sides of the swab. Repeat this with a second swab and let the solution dry without blotting. For nasal application, clean the inside of both nostrils with a tissue, then use a swab dipped in the solution to clean each nostril for 30 seconds total, rotating the swab to cover all surfaces. Use a fresh swab for each nostril and avoid blowing your nose afterward; if any solution drips out, you can lightly dab it with a tissue.
What to Avoid
It's important to be cautious when using this product. You should not use it if you have known allergies to chlorhexidine gluconate or any other ingredients in the product. Avoid using it for lumbar punctures (a procedure to collect spinal fluid) or in contact with the meninges (the protective membranes covering the brain and spinal cord). Additionally, do not apply it to open skin wounds or use it as a general skin cleanser. If you are sensitive to iodine or any other ingredient in this product, refrain from using it.
Make sure to keep the product away from your eyes; if it accidentally gets in, flush your eyes immediately with water. Lastly, this product should not be used on infants younger than 2 months old due to the risk of increased blood iodine levels. Always prioritize safety and consult a healthcare professional if you have any questions or concerns.
Side Effects
It's important to use this product only as directed, specifically for external use only. You should avoid using it if you have known allergies to chlorhexidine gluconate or any other ingredients in the product. Additionally, do not use it for lumbar punctures (a procedure to collect spinal fluid) or on open skin wounds, and it should not be used as a general skin cleanser.
If you experience any adverse reactions, please consult your healthcare provider for guidance.
Warnings and Precautions
This product is for external use only. You should not use it if you are allergic to chlorhexidine gluconate or any of its ingredients. Avoid using it for lumbar punctures (a procedure to collect spinal fluid) or on open skin wounds, and do not use it as a general skin cleanser. Be careful to keep it away from your eyes, ears, and mouth, as it can cause serious injury if it gets in those areas. If contact occurs, rinse with cold water immediately and seek medical attention. Additionally, do not use this product on infants under 2 months old due to the risk of increased blood iodine levels.
If you accidentally swallow this product, seek medical help or contact a Poison Control Center right away. You should also stop using the product and call your doctor if you experience any irritation, sensitization, or allergic reactions, as these could indicate a more serious issue.
Overdose
If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.
In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.
Pregnancy Use
It’s important to be cautious when using certain products during pregnancy, especially if you have young children. Avoid using this product in or around your eyes; if it accidentally gets into your eyes, rinse them immediately with water.
If you have an infant, be aware that this product should not be used on babies younger than 2 months old, as it may lead to increased blood iodine levels. Additionally, use this product with care around premature infants or those under 2 months, as it can cause irritation or even chemical burns. Always consult with your healthcare provider if you have any concerns about using this product during pregnancy or around your children.
Lactation Use
When it comes to breastfeeding, there is currently no specific information available regarding the safety or effects of this medication for nursing mothers or during lactation (the period of breastfeeding). This means that if you are breastfeeding, it’s important to consult with your healthcare provider to discuss any potential risks or concerns related to your medication. They can help you make informed decisions that prioritize both your health and your baby's well-being.
Pediatric Use
It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.
For infants, especially those under 2 months old, you should avoid using this product entirely, as it can lead to increased blood iodine levels. If you have a premature infant or an infant younger than 2 months, use this medication with caution, as it may cause irritation or even chemical burns. Always prioritize safety and consult your healthcare provider if you have any concerns.
Geriatric Use
When using this medication in older adults, it's important to proceed with caution. You may notice that older individuals can be more sensitive to side effects, so close monitoring is essential. Additionally, if kidney function is reduced, which is common in older adults, the dosage may need to be adjusted to ensure safety and effectiveness.
Be vigilant for any signs of irritation, sensitization, or allergic reactions, as these can be more severe in elderly patients. If you or your loved one has known allergies or sensitivities to chlorhexidine gluconate or iodine, special precautions should be taken. Always consult with a healthcare provider to ensure the best care.
Renal Impairment
If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.
Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.
Hepatic Impairment
If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.
Drug Interactions
It's important to be aware of potential interactions when using any medication. If you have known allergies to chlorhexidine gluconate or any other ingredients in this product, you should avoid using it. Additionally, if you are sensitive to iodine or any other components, it's best not to use this product either.
While there are no specific drug or laboratory test interactions noted, it's always a good idea to discuss all medications and tests with your healthcare provider. They can help ensure your safety and the effectiveness of your treatment.
Storage and Handling
To ensure the best use of your product, store it at room temperature and avoid microwaving it. Remember that both the product and its packaging are not sterile, so it's important to follow your hospital's guidelines for skin preparation when using non-sterile items.
When applying the product, make sure your skin is clean and dry. After using each cloth, discard it immediately, and if you open a package but don’t use all the cloths, be sure to throw away any unused ones. Allow the prep solution to dry completely on your skin without blotting it. If any solution drips from your nose, you can gently dab it with a tissue. Always discard swabs after use to maintain safety and hygiene.
Additional Information
This medication is applied topically, meaning you will use it on the skin. It's important to keep this product out of reach of children. If someone accidentally swallows it, seek medical help or contact a Poison Control Center immediately.
Before using this product, make sure you are not allergic to chlorhexidine gluconate or any other ingredients in it. If you have a known sensitivity to iodine or any other component, do not use it. If you experience irritation, sensitization (a heightened response to the product), or an allergic reaction, stop using it and consult a doctor, as these could indicate a serious issue.
FAQ
What is 2% Chlorhexidine Gluconate Cloth used for?
2% Chlorhexidine Gluconate Cloth helps reduce bacteria that can potentially cause skin infections and is used for preparation of skin prior to surgery.
Are there any precautions for using 2% Chlorhexidine Gluconate Cloth in infants?
Yes, use with care in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.
What should I do if the product gets into my eyes?
If the product gets into your eyes, flush immediately with water.
Can I use 2% Chlorhexidine Gluconate Cloth on open skin wounds?
No, do not use on open skin wounds or as a general skin cleanser.
How should I store 2% Chlorhexidine Gluconate Cloth?
Store at room temperature and do not microwave. Follow hospital policy for skin preparation with non-sterile products.
What should I do with unused cloths after opening the package?
After the package has been opened, discard any unused cloths.
What are the instructions for using the cloths?
Use the first cloth to prepare the indicated skin area, then use the second cloth for larger areas, ensuring to discard each cloth after a single use.
What should I do if I experience irritation or an allergic reaction?
Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs, as these may be signs of a serious condition.
Is 2% Chlorhexidine Gluconate Cloth safe for elderly patients?
Use with care in elderly patients due to potential increased sensitivity to side effects.
What should I do if I swallow 2% Chlorhexidine Gluconate Cloth?
If swallowed, get medical help or contact a Poison Control Center right away.
Packaging Info
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing, Nasal Antisepsis (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 2 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 — Solution
| ||||
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing, Nasal Antisepsis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.
Description
The product is a 2% chlorhexidine gluconate cloth, designed for antiseptic use. It is identified by the National Drug Code (NDC) 053462–705–23. The formulation contains chlorhexidine gluconate at a concentration of 2%, providing effective antimicrobial properties.
Uses and Indications
This drug is indicated for the reduction of bacteria that can potentially cause skin infections. It is specifically utilized for the preparation of the skin prior to surgical procedures.
Dosage and Administration
The 2% Chlorhexidine Gluconate Cloth should be used with caution in premature infants or infants under 2 months of age due to the potential for irritation or chemical burns. It is important to note that the product and packaging are not sterile; therefore, healthcare professionals must adhere to hospital policies regarding skin preparation with non-sterile products.
To open the package, the healthcare professional should hold the top of the package in one hand while lifting the flap on the backside with the other hand. The flap should be grasped at the top and pulled down to tear it away, exposing the foam. Care should be taken to hold the outside of the package to present the foam and cloths to the prep table, minimizing contact between the cloths and the outside of the package to reduce the risk of contamination.
For preparation, the first cloth should be used to prepare the indicated skin area for either a moist or dry site, ensuring that the second cloth remains uncontaminated. For dry surgical sites, such as the abdomen or arm, one cloth should be used to cleanse each 161 cm² area (approximately 5 x 5 inches) of skin. The skin should be vigorously scrubbed back and forth for 3 minutes, ensuring complete wetting of the treatment area, after which the cloth should be discarded. The area must be allowed to air dry for one minute without rinsing. For moist surgical sites, such as the inguinal fold, one cloth should be used to cleanse each 65 cm² area (approximately 2 x 5 inches) of skin, following the same scrubbing and drying protocol. Each cloth is for single use only, and any unused cloths should be discarded after the package has been opened.
The 3M Skin and Nasal Antiseptic is intended for application to clean, dry skin. For skin application, one swab should be dipped into the solution and stirred vigorously for 10 seconds. The swab should be withdrawn slowly to avoid removing the solution during removal. The prep site should be scrubbed for 2 minutes, working from clean to dirty, using both sides of the swab. This process should be repeated with a second swab. The prep solution must be allowed to dry without blotting.
For nasal application, a tissue should be used to clean the inside of both nostrils, including the inside tip of each nostril, which should then be discarded. The bottle should be tilted slightly, and one swab should be dipped into the solution and stirred vigorously for 10 seconds before being withdrawn slowly. The swab should be inserted comfortably into one nostril and rotated for 15 seconds, covering all surfaces, followed by an additional 15 seconds focusing on the inside tip of the nostril (swab 1). A new swab should be used to repeat this process in the other nostril (swab 2). This application should be repeated in both nostrils using fresh swabs each time (swabs 3 and 4). Patients should be advised not to blow their nose, and if the solution drips out, it can be lightly dabbed with a tissue.
Contraindications
Use of this product is contraindicated in the following situations:
Patients with known allergies to chlorhexidine gluconate or any other ingredients in this product should not use it, as this may lead to severe allergic reactions. The product is also contraindicated for lumbar punctures or any contact with the meninges due to the risk of serious complications.
It should not be applied to open skin wounds or used as a general skin cleanser, as this may exacerbate the condition or lead to adverse effects. Additionally, individuals with a known sensitivity to iodine or any other ingredient in this product should avoid its use to prevent potential allergic reactions.
The product is contraindicated for use in the eyes; in the event of contact, immediate flushing with water is required. Furthermore, it should not be used on infants less than 2 months old due to the risk of increased blood iodine levels, which can pose significant health risks.
Warnings and Precautions
For external use only. This product is contraindicated in patients with known allergies to chlorhexidine gluconate or any other ingredients contained within. It should not be utilized for lumbar punctures or in contact with the meninges. Additionally, the product is not intended for application on open skin wounds or as a general skin cleanser.
Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious or permanent injury if chlorhexidine is allowed to enter and remain in these areas. In the event of contact, it is imperative to rinse the affected area with cold water immediately and seek medical attention. The product should not be used by individuals with a known sensitivity to iodine or any other ingredient present in the formulation.
Particular caution is advised when considering use in infants; this product is not recommended for infants less than 2 months old due to the potential risk of increased blood iodine levels.
In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.
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 requiring further evaluation.
Side Effects
Patients should be aware that this product is intended for external use only. It is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, the product should not be used for lumbar punctures or in contact with the meninges, nor should it be applied to open skin wounds or utilized as a general skin cleanser.
While specific adverse reactions have not been detailed in the provided data, the contraindications highlight the importance of careful patient selection to avoid potential serious reactions associated with inappropriate use. It is essential for healthcare providers to assess patient history for allergies and to ensure that the product is used in accordance with the specified guidelines to minimize risks.
Drug Interactions
Patients with known allergies to chlorhexidine gluconate or any other ingredients in this product should not use it. Additionally, individuals with a known sensitivity to iodine or any other component of this formulation are also advised against its use.
There are no specific drug or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.
Packaging & NDC
Below are the non-prescription pack sizes of Skin Antisepsis, Oral Cleansing, Nasal Antisepsis (chlorhexidine gluconate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Cloth | 500 mg | ||
Kit Contents Each kit contains 2 components packaged together. Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Part 1 — Cloth
Part 2 — Solution
| ||||
Pediatric Use
Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.
The use of this product is contraindicated in infants less than 2 months old due to the potential risk of increased blood iodine levels. Caution is also warranted when administering to premature infants or infants under 2 months of age, as these products may lead to irritation or chemical burns.
Geriatric Use
Elderly patients may exhibit increased sensitivity to side effects, necessitating careful consideration when prescribing this medication. It is important to take into account the potential for reduced kidney function in this population, which may require dosage adjustments to ensure safety and efficacy.
Healthcare providers should closely monitor elderly patients for signs of irritation, sensitization, or allergic reactions, as these adverse effects may be more pronounced in this demographic. Special precautions are warranted for elderly patients with known allergies or sensitivities to chlorhexidine gluconate or iodine, as they may be at an elevated risk for adverse reactions.
Pregnancy
Pregnant patients should be advised against the use of this product in the eyes, as exposure may necessitate immediate flushing with water. There is a specific caution regarding the use of this product in infants less than 2 months old due to the potential risk of increased blood iodine levels. Additionally, the product should be used with care in premature infants or those under 2 months of age, as it may cause irritation or chemical burns. Healthcare professionals should consider these factors when prescribing this product to women of childbearing potential and ensure that appropriate precautions are taken to mitigate any risks to fetal outcomes.
Lactation
There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to weigh the potential benefits against any unknown risks to breastfed infants.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.
Overdosage
In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.
It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.
In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.
Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.
Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.
Nonclinical Toxicology
No relevant information was found regarding teratogenic effects. However, caution is advised when using this product in infants less than 2 months old due to the potential risk of increased blood iodine levels. It is also recommended to use this product with care in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns.
No relevant information was found in the context of animal pharmacology and toxicology.
Postmarketing Experience
Postmarketing experience has identified cases of irritation, sensitization, and allergic reactions associated with the use of chlorhexidine gluconate products. These reactions may indicate the presence of a serious condition. Reports of these events have been received voluntarily and through surveillance programs, highlighting the need for continued monitoring of patient responses to these products.
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.
It is important to inform patients that this product should not be used on individuals with known allergies to chlorhexidine gluconate or any other ingredients contained in the formulation. Additionally, patients should be cautioned against using this product for lumbar punctures or in contact with the meninges, as well as on open skin wounds or as a general skin cleanser.
When using this product, patients must be instructed to avoid contact with the eyes, ears, and mouth, as chlorhexidine can cause serious or permanent injury if it enters these areas. In case of contact, patients should rinse the affected area with cold water immediately and seek medical attention.
Patients should also be made aware that this product is contraindicated for those with a known sensitivity to iodine or any other ingredient in the formulation. If the product accidentally gets into the eyes, patients should flush immediately with water.
Furthermore, this product should not be used on infants less than 2 months old due to the risk of increased blood iodine levels. Patients should be advised to discontinue use and consult a doctor if they experience irritation, sensitization, or an allergic reaction, as these may indicate a serious condition.
Storage and Handling
The product is supplied at room temperature and should not be microwaved. It is important to note that both the product and its packaging are not sterile; therefore, healthcare professionals should adhere to hospital policies regarding skin preparation with non-sterile products. Each cloth is intended for single use and must be discarded after application. Once the package has been opened, any unused cloths should also be discarded.
For optimal application, the product should be applied to clean, dry skin. After application, the prep solution should be allowed to dry completely; it is advised not to blot the area. Additionally, swabs should be discarded immediately after use. In the event that the solution drips out of the nose, it may be lightly dabbed with a tissue.
Additional Clinical Information
The product is administered topically. Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed. It is contraindicated for use in patients with known allergies to chlorhexidine gluconate or any other ingredients in the formulation, as well as those with a known sensitivity to iodine or any other component. Patients should be advised to discontinue use and consult a physician if they experience irritation, sensitization, or an allergic reaction, as these may indicate a serious condition.
Drug Information (PDF)
This file contains official product information for Skin Antisepsis, Oral Cleansing, Nasal Antisepsis, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.