Antimicrobial Skin Cleanser

Description

Chlorhexidine Gluconate 2% Solution is an antimicrobial skin cleanser indicated for antiseptic use. This product is distributed by Gojo Industries, Inc., located in Akron, OH 44309. The solution is packaged in a net content of 32 fluid ounces (1 quart or 946 mL) and is identified under the National Drug Code (NDC) 21749-106-32. It is marketed under the PROVON brand.

Uses and Indications

This drug is indicated for use as a healthcare personnel handwash, assisting in the reduction of bacteria that may potentially cause disease. Additionally, it 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.

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

Dosage and Administration

Healthcare personnel should adhere to the following procedures for hand hygiene to ensure optimal effectiveness of the product.

For routine handwashing, healthcare personnel must first wet their hands with water. They should then dispense 5 mL of the product, which corresponds to four full strokes, into cupped hands. The hands should be washed vigorously for a duration of 15 seconds, ensuring thorough coverage. After washing, hands must be dried thoroughly.

In the case of a surgical hand scrub, healthcare personnel should begin by wetting their hands and forearms with water. They are to scrub for 3 minutes using 5 mL of the product (four full strokes) along with a wet brush, paying particular attention to the nails, cuticles, and the skin between the fingers. A separate nail cleaner may be utilized if necessary. Following this initial scrub, hands and forearms should be rinsed thoroughly. Subsequently, an additional scrub for 3 minutes is required, again using 5 mL of the product (four full strokes), followed by rinsing under running water. Finally, hands and forearms must be dried thoroughly to complete the procedure.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation.

Additionally, the product should not be used routinely in patients with wounds that extend beyond the superficial layers of the skin due to the potential for adverse effects.

Contact with the eyes, ears, or mouth is contraindicated, as exposure may result in serious and permanent eye injury or deafness if introduced through a perforated eardrum. In the event of contact with these areas, it is imperative to rinse thoroughly with water.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should be aware of the potential for severe allergic reactions associated with its use. 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.

Caution is advised for individuals with known allergies to chlorhexidine gluconate or any other components of this formulation. The use of this product in such cases is contraindicated.

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

In cases of accidental ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center without delay.

Side Effects

Patients may experience a range of adverse reactions associated with this product. Notably, there is a significant allergy alert, as the product has the potential to cause severe allergic reactions. Symptoms 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 that patients discontinue use immediately and seek medical assistance.

In addition to allergic reactions, other adverse effects may include irritation, sensitization, or allergic reactions, which could indicate the presence of a serious condition. It is essential for patients to be aware of these potential reactions and to monitor for any signs of adverse effects during the use of this product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Antimicrobial Skin Cleanser (chlorhexidine gluconate 2% solution). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly premature infants 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 under 2 months of age. Caution is advised as these products may lead to irritation or chemical burns in this vulnerable population. It is essential for healthcare providers to assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place to mitigate potential adverse effects.

Pregnancy

The safety of this medication during pregnancy has not been specifically addressed in the available data. There are no documented safety concerns related to the use of this medication in pregnant patients. Additionally, there are no dosage modifications recommended for individuals who are pregnant. Furthermore, no special precautions regarding the use of this medication during pregnancy have been outlined. Healthcare professionals should consider the potential benefits and risks when prescribing this medication to women of childbearing potential.

Lactation

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

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare professionals are advised to remain vigilant and prepared to manage any symptoms that may arise as a result of an overdose.

The management of overdosage should be guided by the clinical presentation of the patient and may involve supportive care and symptomatic treatment as necessary. Continuous monitoring and assessment of the patient's condition are essential to ensure appropriate interventions are implemented in a timely manner.

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 compound in these areas.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Allergic reactions, including anaphylaxis, as well as skin reactions such as rash, pruritus, and urticaria have been documented. Additionally, reports of serious eye injuries, including corneal damage and blindness, have been received, particularly associated with accidental exposure to the product.

Cases of chemical burns have been reported, notably in premature infants and individuals with compromised skin integrity. Furthermore, instances of ototoxicity have been observed when the solution was instilled in the middle ear through perforated eardrums.

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 essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

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

When discussing the proper use of this product, healthcare providers should emphasize the importance of avoiding contact with the eyes, ears, and mouth. Patients should be made aware that exposure to these areas may result in serious and permanent eye injury or potential deafness if the solution is instilled through the middle ear in the presence of a perforated eardrum. In the event of contact with these sensitive areas, patients should rinse thoroughly with water immediately.

Additionally, healthcare providers should caution patients against routine use of the product if they have wounds that extend beyond the superficial layers of the skin, as this may pose additional risks.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25ºC (68-77ºF). Care should be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40ºC (104ºF). Proper storage conditions are crucial 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 Antimicrobial Skin Cleanser, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)