Dr. Dean

Description

Chlorhexidine Gluconate is a 4.0% liquid solution formulated as an antimicrobial skin soap intended for external use only. It is distributed by USA Medical Supply, located in Northbrook, IL 60062. The product is available in multiple sizes, with National Drug Code (NDC) identifiers: 81657-003-01 for 4 FL OZ (118 mL), 81657-003-02 for 8 FL OZ (236 mL), and 81657-003-03 for 128 FL OZ (3785 mL). Chlorhexidine Gluconate is manufactured in the USA and is FDA approved. Further information can be found at www.usamdsupply.com.

Uses and Indications

This drug is indicated for use as a surgical hand scrub, significantly reducing the number of microorganisms on the hands and forearms prior to surgical procedures 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 serves as a skin wound and general cleanser, helping to reduce bacteria on the skin.

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

Dosage and Administration

Surgical hand scrub requires the removal of all jewelry prior to use. Healthcare professionals should wet their hands and forearms with water, then apply 5 mL of the product. A thorough wash or scrub of the hands and forearms should be performed for 3 minutes, with particular attention given to the nails, cuticles, and interdigital spaces. After scrubbing, hands and forearms must be rinsed thoroughly with water. Following this, an additional wash for 3 minutes using another 5 mL of the product is necessary, followed by another rinse under running water. Finally, hands and forearms should be dried thoroughly.

For healthcare personnel handwashing, the process begins with wetting the hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for 30 seconds. After washing, hands must be rinsed and dried thoroughly.

When using the product as a skin wound and general skin cleanser, the area to be cleansed should first be thoroughly rinsed with water. The minimum amount of product necessary to cover the skin or wound area should then be applied, followed by gentle washing. It is essential to rinse thoroughly with water, and a second thorough rinse is required to ensure complete cleansing.

Contraindications

Use of this preparation is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other components of this formulation should not use this product.

This preparation is not to be utilized as a preoperative skin preparation, particularly on the head or face, due to the potential for adverse reactions in these sensitive areas.

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

Additionally, the use of this product in the genital area is not recommended, as it may cause irritation or other 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.

This product is contraindicated in individuals with known allergies to chlorhexidine gluconate or any other components of the formulation. It should not be utilized as a preoperative skin preparation, particularly on the head or face, nor should it come into contact with the meninges or be applied to the genital area.

When administering this product, it is crucial to avoid contact with the eyes, ears, and mouth. Exposure to the eyes can result in serious and permanent injury, while instillation in the middle ear through perforated eardrums may lead to deafness. Should contact with these areas occur, immediate rinsing with cold water is recommended.

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 irritation, sensitization, or allergic reactions persist for 72 hours, as these may indicate a serious condition. It is also essential to keep this product out of reach of children. In the event of ingestion, immediate medical attention or contact with a Poison Control Center is advised.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious. A notable concern is the potential for 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.

It is critical to avoid using this product in certain situations. Patients should not use it if they are allergic to chlorhexidine gluconate or any other ingredients in the formulation. Additionally, the product should not be applied as a preoperative skin preparation, particularly on the head or face, nor should it come into contact with the meninges or be used in the genital area.

While using this product, patients must take precautions to prevent contact with the eyes, ears, and mouth, as such exposure may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should contact occur, it is imperative to rinse the affected area with cold water immediately. 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 be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients are advised to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or an allergic reaction that persists for 72 hours, as these symptoms may indicate a serious condition.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Dr. Dean (chlorhexidine gluconate liquid solution 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The product has not been specifically studied for use during pregnancy, and there are no detailed safety concerns associated with its use in this population. Currently, there are no dosage modifications recommended for pregnant individuals. Additionally, the prescribing information does not outline any special precautions for the use of this product during pregnancy. Healthcare professionals should consider the lack of specific data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

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 drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable among these are allergic reactions, which can manifest as severe symptoms including wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been observed, with some cases lasting up to 72 hours, potentially indicating a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

It is important to inform patients to avoid contact with the eyes, ears, and mouth, as the medication may cause serious and permanent eye injury if it comes into contact with the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness. In the event of contact with these areas, patients should rinse with cold water immediately.

Healthcare providers should counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this medication. They should also emphasize that repeated general skin cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

Patients should be instructed to stop using the medication and consult a doctor if they experience irritation, sensitization, or an allergic reaction that lasts for 72 hours, as these symptoms may indicate a serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25 °C (68-77 °F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, defined as temperatures above 104 °F (40 °C). For further details regarding safety and handling, please refer to the Safety Data Sheet (SDS).

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should counsel patients on the potential for severe allergic reactions, which may manifest as wheezing, difficulty breathing, shock, facial swelling, hives, or rash. Patients are advised to discontinue use and seek immediate medical assistance if any allergic symptoms occur. Additionally, the product should be kept out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center is recommended.

Drug Information (PDF)

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

View product document (PDF)