Bactoshield Chg

Description

Bactoshield is a non-sterile surgical scrub containing 4% chlorhexidine gluconate (CHG) as the active ingredient. This antimicrobial solution is intended for single use and is packaged in a net volume of 4 fluid ounces (118 mL). The product is manufactured for SCJ Professional USA, Inc., located in Charlotte, NC 28217. The National Drug Code (NDC) for Bactoshield is 11084-039-03. For further information, contact SCJ Professional at 1-866-783-0422 or visit www.scjp.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 is utilized for patient preoperative skin preparation, ensuring the skin is adequately prepared prior to surgery. Furthermore, it is 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 scrubs should begin with wetting the hands and forearms with water. Approximately 5 mL of the product should be used in conjunction with a wet brush to scrub for a duration of 3 minutes, ensuring meticulous attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, the hands and forearms must be rinsed thoroughly. An additional wash should be performed for another 3 minutes using 5 mL of the product, followed by rinsing under running water. It is essential to dry the hands and forearms thoroughly after the procedure.

For healthcare personnel handwashing, the process begins with 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, the hands must 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 should be swabbed for a minimum of 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. A thorough rinse is required once again to complete the cleaning process.

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 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 without delay.

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 potentially permanent eye injury or deafness, particularly 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. Additionally, wounds that extend beyond the superficial layers of the skin should not be treated routinely with this product. Repeated cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

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

Healthcare professionals should advise patients to discontinue use and consult a physician if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious underlying condition.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

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

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

It is important to note that this product should not be used by individuals who are allergic 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.

When using this product, care 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 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, 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 Bactoshield Chg (chlorhexidine gluconate 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 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. It is essential to assess the safety and efficacy of the treatment in geriatric patients, ensuring that any necessary dose adjustments or additional monitoring are implemented to mitigate adverse effects.

Pregnancy

There are no specific statements regarding the use of chlorhexidine gluconate 4% solution during pregnancy. The available prescribing information does not mention any safety concerns, contraindications, or special precautions associated with the use of this product in pregnant patients. Additionally, no dosage modifications for pregnant individuals are indicated. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

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 drug. 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. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include severe manifestations such as wheezing or difficulty breathing, shock, facial swelling, hives, and rash.

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 avoid contact with 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 that the solution comes into contact with the eyes, ears, or mouth, patients should be instructed to rinse the affected area promptly and thoroughly with water. Providers should also counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product.

Additionally, patients should be made aware that repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider. It is important to instruct patients to discontinue use and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these symptoms may indicate a serious condition.

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 exercise caution when using this product in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. Patients should be advised to discontinue use and seek medical assistance immediately if an allergic reaction occurs. Additionally, it is important to keep the product out of reach of children; if ingested, medical help or contact with a Poison Control Center should be sought promptly.

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.

View product document (PDF)