Dr. Dean

Description

Dr. Dean Chlorhexidine Gluconate is an antimicrobial skin soap available as a liquid solution at a concentration of 2.0%. This formulation provides up to 6 hours of protection and is intended for external use only. The product is distributed by USA Medical Supply, located in Northbrook, IL 60062, and is FDA approved. It is available in multiple sizes: 4 FL OZ (118 mL) with NDC 81657-002-01, 8 FL OZ (236 mL) with NDC 81657-002-02, and 128 FL OZ (3785 mL) with NDC 81657-002-03. All sizes are manufactured in the USA. For more information, visit 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, assisting 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 with 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 recommended 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 due to the risk of severe allergic reactions.

This product is not to be used as a preoperative skin preparation, particularly on the head or face, as it may lead to adverse effects in these sensitive areas.

Contact with the meninges is contraindicated, as it poses a risk of serious complications.

Additionally, the use of this preparation in the genital area is contraindicated to prevent potential irritation or adverse reactions.

Warnings and Precautions

For external use only. This product carries a significant risk of causing 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.

General precautions must be observed to ensure safe application. The product should be kept out of the eyes, ears, and mouth, as contact may result in serious and permanent eye injury if introduced into the eye during surgical procedures. Additionally, instillation into the middle ear through perforated eardrums may lead to deafness. Should contact with these areas occur, it is essential to rinse with cold water immediately.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Furthermore, repeated cleansing of large body areas should be avoided unless necessary to reduce the bacterial population due to an underlying condition.

In cases of ingestion, immediate medical help should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if irritation, sensitization, or any allergic reaction persists for 72 hours, as these symptoms may indicate a serious condition.

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 wheezing or difficulty breathing, shock, facial swelling, hives, or 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 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 Dr. Dean (chlorhexidine gluconate liquid solution 2%). 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

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

There are no specific statements regarding the use of chlorhexidine gluconate during pregnancy in the available prescribing information. The insert does not mention any contraindications or risks associated with the use of chlorhexidine gluconate in pregnant individuals. Additionally, no dosage modifications for pregnant individuals are specified. Furthermore, the insert does not provide any special precautions regarding the use of chlorhexidine gluconate during pregnancy. As such, healthcare professionals should consider the absence of data when advising pregnant patients or women of childbearing potential regarding the use of this agent.

Lactation

Lactating mothers should use this product with caution, particularly in the case of premature infants or those under 2 months of age. There is a risk that the product may cause irritation or chemical burns in these vulnerable populations. It is advisable for healthcare professionals to closely monitor breastfed infants for any adverse reactions when this product is used by lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 available 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the potential for severe allergic reactions associated with this product. Symptoms reported include wheezing or difficulty breathing, shock, facial swelling, hives, and rash. In the event of an allergic reaction, it is advised to discontinue use and seek immediate medical assistance. Additionally, users are instructed to stop use and consult a healthcare professional if irritation, sensitization, or an allergic reaction persists for 72 hours, as these may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this 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 this 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. Furthermore, 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 configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25 °C (68-77 °F) to maintain its integrity. 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. Clinicians should exercise caution when prescribing this treatment to premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns. In the event of accidental ingestion, patients or caregivers are advised to seek medical assistance or contact a Poison Control Center immediately.

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)