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Antiseptic Skin Cleanser

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Active ingredient
Chlorhexidine Gluconate 4 mg/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
December 19, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Chlorhexidine Gluconate 4 mg/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2012
Label revision date
December 19, 2018
Manufacturer
Chain Drug Consortium, LLC
Registration number
NDA019125
NDC root
68016-228
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

Premier Value is an antiseptic skin cleanser that contains chlorhexidine gluconate (a powerful antiseptic) in a 4% solution. It is primarily used for handwashing by healthcare personnel to help reduce bacteria that can cause disease, as well as for cleaning skin wounds and general skin hygiene.

This product is intended for external use only and is dye-free, making it suitable for a variety of skin cleaning needs.

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 and preventing the spread of infections.

Additionally, it is suitable for cleaning skin wounds and for general skin cleaning. This means you can use it to help keep your skin clean and to care for minor wounds, promoting better healing and reducing the risk of infection.

Dosage and Administration

To ensure proper hygiene, it's important for healthcare personnel to wash their hands correctly. Start by wetting your hands with water. Then, dispense about 5ml of the cleansing product into your cupped hands and wash them vigorously for about 15 seconds. After that, rinse your hands thoroughly and dry them completely.

If you need to clean a skin wound or just normal skin, begin by rinsing the area with water. Next, apply just enough of the cleansing product to cover the skin or wound, and wash it gently. Finally, rinse the area thoroughly again to ensure it's clean. Following these steps helps maintain cleanliness and prevent infections.

What to Avoid

You should avoid using this product if you are allergic to chlorhexidine gluconate or any of its ingredients. It is also important not to use it in contact with the meninges (the protective membranes covering the brain and spinal cord) or in the genital area. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

Be cautious to keep the solution away from your eyes, ears, and mouth, as it can cause serious injuries, including permanent eye damage or deafness if it enters the middle ear through a perforated eardrum. If the solution comes into contact with these areas, rinse thoroughly with water. Additionally, do not use it on wounds that go deeper than the surface of the skin, and avoid repeated cleansing of large body areas unless directed by a healthcare provider. If you experience irritation, sensitization, or an allergic reaction, stop using the product and consult your doctor, as these could indicate a serious condition.

Side Effects

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

You should not use this product if you are allergic to chlorhexidine gluconate or any of its ingredients, or if it comes into contact with the meninges (the protective membranes covering the brain and spinal cord) or the genital area. Be cautious to avoid contact with your eyes, ears, and mouth, as this can lead to serious injuries. If irritation, sensitization, or an allergic reaction occurs, discontinue use and consult a doctor. Additionally, this product contains a substance that may cause cancer, so please refer to the provided warning for more details. Keep this product out of reach of children, and if swallowed, seek medical assistance immediately.

Warnings and Precautions

This product is for external use only and may cause severe allergic reactions. If you experience symptoms like wheezing, difficulty breathing, facial swelling, hives, or a rash, stop using the product immediately and seek medical help. Avoid using it if you are allergic to chlorhexidine gluconate or any other ingredients in the product, and do not apply it to the genital area or near the meninges (the protective membranes covering the brain and spinal cord).

While using this product, be careful 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 it does, rinse thoroughly with water right away. Do not use it on deep wounds or large areas of skin unless directed by a healthcare provider. If you notice any irritation, sensitization, or allergic reactions, stop using the product and consult your doctor. If swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, be aware that this product contains a substance linked to cancer, so you may want to review more information at www.P65Warnings.ca.gov.

Overdose

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

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

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the information regarding the use of this product during pregnancy is limited. The product has not been specifically studied for safety in pregnant individuals, and there are no detailed safety concerns or special precautions mentioned in the available information. Additionally, there are no recommended dosage modifications for pregnant individuals.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be cautious when using certain medications, especially if your baby is a premature infant or under 2 months old. These products can potentially cause irritation or chemical burns in young infants, so you should consult your healthcare provider before using them. Always prioritize your baby's safety and well-being when considering any medication while nursing.

Pediatric Use

When considering this medication for your child, it's important to use it with caution, especially if your child is a premature infant or younger than 2 months old. In these cases, the medication may cause irritation or even chemical burns. Always consult with your child's healthcare provider to ensure safe use and to discuss any concerns you may have regarding their age and health status.

Geriatric Use

When 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 the safety and appropriateness of any treatment, particularly for those who may have specific health concerns or sensitivities. Your healthcare provider can help guide you in making the best choices for the well-being of older adults and young infants alike.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be aware that using chlorhexidine gluconate skin cleansers alongside chlorine-releasing products, like chlorine bleach, can lead to staining. To avoid this issue, make sure to rinse your skin thoroughly after using the cleanser and opt for non-chlorine detergents instead.

Always discuss any medications or products you are using with your healthcare provider. They can help you understand potential interactions and ensure you are using products safely and effectively.

Storage and Handling

To ensure the best performance 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 means keeping it below 40° C (104° F).

When handling the product, make sure to do so with clean hands and in a safe environment to maintain its integrity. Following these guidelines will help you use the product effectively and safely.

Additional Information

No further information is available.

FAQ

What is Premier Value?

Premier Value is an antiseptic skin cleanser that contains chlorhexidine gluconate 4% solution.

What are the key uses of Premier Value?

It is used for healthcare personnel handwashing to reduce bacteria and for skin wound and general skin cleaning.

Is Premier Value safe for use during pregnancy?

The product has not been specifically mentioned in relation to pregnancy use, and no special precautions are noted.

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

Stop using the product and ask a doctor if irritation, sensitization, or allergic reaction occurs.

How should I use Premier Value for handwashing?

Wet your hands, dispense about 5ml of the product, wash vigorously for about 15 seconds, then rinse and dry thoroughly.

What precautions should I take when using this product?

Keep it out of your eyes, ears, and mouth, as it may cause serious injury if it enters these areas.

What should I do if the product is swallowed?

Get medical help or contact a Poison Control Center right away.

Can I use Premier Value on large body areas?

Repeated general skin cleansing of large body areas should only be done when advised by a healthcare provider.

What are the storage conditions for Premier Value?

Store at 20°-25° C (68°-77° F) and avoid excessive heat above 40° C (104° F).

Is Premier Value dye-free?

Yes, Premier Value is dye-free.

Packaging Info

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antiseptic Skin Cleanser.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value Antiseptic Skin Cleanser is formulated to compare to the active ingredient in Hibiclens®, containing Chlorhexidine Gluconate at a concentration of 4%. This antiseptic and antimicrobial solution is intended for external use only and is presented in a dye-free formulation. The product is packaged in an 8 fluid ounce (237 mL) container. It is important to note that the product should not be used if the safety seal is broken or missing.

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 cleaning.

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 thoroughly once more to ensure complete removal of the product.

Contraindications

Use of this product is contraindicated in the following situations:

  • Known allergy to chlorhexidine gluconate or any other component of the formulation.

  • Contact with the meninges is contraindicated due to the risk of serious complications.

  • Application in the genital area is not recommended.

Additionally, the product should not be used in the following circumstances:

  • If ingested, seek immediate medical assistance or contact a Poison Control Center.

  • Avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent injury, including potential deafness if introduced into the middle ear through perforated eardrums. If contact occurs, rinse thoroughly with water.

  • Do not routinely treat wounds that extend beyond the superficial layers of the skin.

  • Repeated cleansing of large body areas is discouraged unless specifically directed by a healthcare provider.

  • Discontinue use and consult a physician if signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition.

Warnings and Precautions

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

This product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. Additionally, it should not be applied in contact with the meninges or used in the genital area.

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

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Furthermore, repeated general skin cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

Healthcare professionals should instruct 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 the event of accidental ingestion, immediate medical attention should be sought, or contact with a Poison Control Center is recommended.

It is important to note that this product may expose users to coconut oil diethanolamine condensate (cocamide diethanolamine), a substance recognized by the State of California as a potential carcinogen. For further information, please refer to www.P65Warnings.ca.gov.

Side Effects

Patients using this product should be aware that it is for external use only. There is a significant risk of severe allergic reactions, which may manifest as symptoms including wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, it is contraindicated for use in contact with the meninges or in the genital area.

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 instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is recommended 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.

Patients should discontinue use and consult a physician if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical help or contact with a Poison Control Center is necessary.

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

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach, leading to staining. To mitigate this interaction, it is advised to rinse the skin thoroughly after using chlorhexidine gluconate and to utilize only non-chlorine detergents for cleaning purposes.

Packaging & NDC

Below are the non-prescription pack sizes of Antiseptic Skin Cleanser (chlorhexidine gluconate 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Antiseptic Skin Cleanser.
Details

Pediatric Use

Pediatric patients, particularly premature infants and those under 2 months of age, should be treated with caution. The use of these products in this population may lead to irritation or chemical burns. It is essential for healthcare professionals to closely monitor these patients to mitigate potential risks associated with their use.

Geriatric Use

Elderly patients should be monitored closely when using this medication, particularly those who are premature infants or infants under 2 months of age. The use of this product in these populations may lead to irritation or chemical burns. Caution is advised, and healthcare providers should consider the potential risks associated with its use in these vulnerable groups. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

The product has not been specifically studied in pregnant patients, and there are no detailed safety concerns regarding its use during pregnancy. Current prescribing information does not provide any dosage modifications for pregnant individuals. Additionally, no special precautions regarding the use of this product during pregnancy have been mentioned. Healthcare professionals should consider the lack of specific data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in breastfed infants. Therefore, careful consideration and monitoring are advised when administering this product to lactating mothers who are nursing young infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function to ensure safety and efficacy.

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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment as necessary. It is recommended that healthcare providers follow established protocols for the management of overdosage, which may involve the administration of activated charcoal, intravenous fluids, or other interventions based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of a Poison Control Center can provide valuable guidance on the appropriate management strategies tailored to the specific circumstances of the case.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of the compound's potential effects in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of this product. Reports include allergic reactions, which may manifest as severe symptoms such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, there have been instances of irritation, sensitization, or allergic reactions occurring with the use of this product. 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 crucial for patients to understand the potential risks associated with the ingredients in the product. Specifically, healthcare providers should inform patients that this product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is recognized by the State of California as a substance that may cause cancer. Patients are encouraged to visit www.P65Warnings.ca.gov for further information regarding this warning.

Storage and Handling

The product is supplied in various configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20° to 25° C (68° to 77° F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40° C (104° F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Antiseptic Skin Cleanser, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.