Bactoshield Chg

Description

SCJ Professional Bactoshield is a non-sterile surgical scrub containing 2% chlorhexidine gluconate (CHG) as the active ingredient. This antimicrobial solution is intended for single use and is formulated to provide effective antiseptic properties. The product is presented in a 4 fluid ounce (118 mL) container. It is manufactured for SCJ Professional USA, Inc., located in Charlotte, NC 28217. The National Drug Code (NDC) for this product is 11084-038-03. For further information, contact 1-866-783-0422 or visit www.scjp.com.

Uses and Indications

This drug is indicated for surgical hand scrubs, significantly reducing the number of microorganisms on the hands and forearms prior to surgery 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 is used for patient preoperative skin preparation, ensuring the patient's skin is adequately prepared prior to surgical procedures. It is further indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Surgical hand scrub requires the following steps: First, healthcare professionals should wet their hands and forearms under running water for 30 seconds. Fingernails must be cleaned using a nailstick or similar cleaner. Next, approximately 8 mL of the product should be used to scrub for 1.5 minutes, with or without a wet brush, ensuring thorough attention to the nails, cuticles, and skin between the fingers. After scrubbing, hands should be rinsed thoroughly under running water for 30 seconds. This process should be repeated with an additional 8 mL of product, followed by another 30-second rinse under running water. Finally, hands must be dried thoroughly.

For healthcare personnel handwashing, the procedure begins by wetting the hands with water. About 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for 15 seconds. After washing, hands should be rinsed and dried thoroughly.

In the case of patient preoperative skin preparation, the product should be applied liberally to the surgical site. The area must be swabbed for at least 2 minutes and then dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with a sterile towel.

For skin wound and general skin cleaning, the area to be cleaned 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. The area must be rinsed thoroughly again to ensure cleanliness.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with a known allergy to chlorhexidine gluconate or any other ingredient in this formulation should not use this product due to the risk of severe allergic reactions.

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

Application in the genital area is not recommended, as it may cause irritation or adverse effects.

Additionally, this product should not be used as a preoperative skin preparation for the head or face to avoid potential complications associated with its use in these sensitive areas.

Warnings and Precautions

For external use only, this product carries the risk of causing a severe allergic reaction. Symptoms indicative of such a reaction 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 away from the eyes, ears, and mouth, as contact with these areas may result in serious and permanent eye injury if introduced during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these sensitive areas, it is essential to rinse thoroughly and promptly with water.

Wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Additionally, repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider to avoid potential adverse effects.

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 any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition requiring further evaluation.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized by seriousness and frequency.

Severe allergic reactions have been reported, which may manifest as wheezing or difficulty breathing, shock, facial swelling, hives, or rash. In the event of an allergic reaction, it is imperative that the patient discontinue use immediately and seek medical assistance.

Common adverse reactions include irritation, sensitization, or allergic reactions. Should any of these symptoms occur, patients are advised to stop using the product and consult a healthcare professional, as they may indicate a serious condition.

It is important to note that this product should not be used in patients with known allergies to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, it should not be applied in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

During use, precautions must be taken to avoid contact with the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury or deafness if the solution is instilled in the middle ear through perforated eardrums. If the solution inadvertently contacts these areas, it should be rinsed out promptly and 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.

Drug Interactions

Chlorhexidine gluconate skin cleansers may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining of the skin. To mitigate this risk, 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 Bactoshield Chg (chlorhexidine gluconate 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 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 or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration.

Healthcare providers are advised to consider these safety concerns when prescribing to geriatric patients, ensuring that appropriate measures are taken to mitigate risks associated with the use of this product in vulnerable populations.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate 2% solution during pregnancy. The available data does not indicate any safety concerns, contraindications, or dosage modifications related to its use in pregnant patients. Additionally, no special precautions regarding the use of this solution during pregnancy are noted in the prescribing information. Healthcare professionals should consider the absence of specific data when advising women of childbearing potential regarding the use of chlorhexidine gluconate 2% solution.

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.

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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

No teratogenic effects have been reported in the available data. Additionally, there is no information regarding non-teratogenic effects. The nonclinical toxicology section does not provide any specific details. Furthermore, there is no information available concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Notable among these are allergic reactions, which may include severe manifestations such as wheezing, difficulty breathing, shock, facial swelling, hives, and rash. Additionally, instances of irritation, sensitization, or allergic reactions have been observed, which could indicate the presence of a serious condition.

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 to inform patients to keep the product away from the eyes, ears, and mouth, as exposure to these areas may result in serious and permanent eye injury if the product is placed or retained in the eye during surgical procedures, or may lead to deafness if instilled in the middle ear through perforated eardrums.

In the event of contact with these sensitive areas, patients should be instructed to rinse thoroughly and promptly with water. Additionally, healthcare providers should counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. It is also important to emphasize that repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Storage and Handling

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

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients should be instructed to discontinue use and seek medical attention immediately if they experience an allergic reaction, irritation, or sensitization, as these may indicate a serious condition. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center without delay.

Drug Information (PDF)

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

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