Bactoshield Chg

Description

Bactoshield® is a non-sterile surgical scrub containing 2% chlorhexidine gluconate (CHG) as the active ingredient. This antimicrobial solution is formulated for single use and is presented in a 4 fluid ounce (118 mL) container. The product is identified by the National Drug Code (NDC) 11084-038-03.

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 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 scrubbed 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 followed by an additional wash for 1.5 minutes using another 8 mL of the product, followed by another 30-second rinse under running water. Finally, hands must be dried thoroughly.

For healthcare personnel handwashing, the procedure 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, 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 complete the cleaning process.

Contraindications

Use of this product is contraindicated in the following situations:

• Known allergy to chlorhexidine gluconate or any other component of the formulation.

• Application in contact with the meninges due to the risk of serious complications.

• Use in the genital area, as it may cause irritation or adverse reactions.

• Application as a preoperative skin preparation on the head or face, which may lead to complications during surgical procedures.

Warnings and Precautions

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

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other component of the formulation. Additionally, it is contraindicated for use in contact with the meninges, in the genital area, or as a preoperative skin preparation for the head or face.

When utilizing this product, it is essential to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should the solution inadvertently contact these areas, it must be rinsed out promptly and thoroughly with water.

Wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product. Furthermore, repeated general skin cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

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.

This product should be kept 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 recommended.

Side Effects

Patients using this product should be aware that it is for external use only. There is a 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.

This product should not be used by individuals who are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. It is contraindicated for use in contact with the meninges, in the genital area, or as a preoperative skin preparation of the head or face.

While using this product, it is crucial to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it should be rinsed out promptly and thoroughly with water. Additionally, 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.

Patients are instructed to stop use and consult a doctor if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. It is also important to keep this product out of reach of children; if swallowed, medical help should be sought immediately or contact with a Poison Control Center should be made.

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 Bactoshield Chg (chlorhexidine gluconate). 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 may exhibit increased sensitivity to side effects, necessitating careful consideration when prescribing this product. Due to the potential for reduced renal function in this population, dosage adjustments should be made accordingly to ensure safety and efficacy.

Healthcare providers are advised to closely monitor elderly patients for signs of irritation, sensitization, or allergic reactions, as these may be more pronounced in this demographic. Additionally, it is crucial to ensure that the product is kept out of reach of elderly patients, particularly those with cognitive impairments, to prevent the risk of accidental ingestion.

Pregnancy

There are no specific statements regarding the use of Bactoshield CHG Chlorhexidine Gluconate Solution during pregnancy. The available data does not indicate any contraindications or risks associated with the use of this product in pregnant individuals, nor does it provide information on potential effects on the fetus. Additionally, no dosage modifications for pregnant individuals are specified in the prescribing information. The insert also does not include any special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the benefits against any potential 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 not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

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

Nonclinical Toxicology

No relevant information was found regarding teratogenic effects, non-teratogenic effects, or any other aspects of nonclinical toxicology. Additionally, there are no findings related to animal pharmacology and 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, difficulty breathing, shock, facial swelling, hives, and rash.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a healthcare professional if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

When using this product, it is essential to avoid contact with the eyes, ears, and mouth. Patients should be made aware that exposure to the eyes can result in serious and permanent injury, particularly if the product is placed or retained in the eye during surgical procedures. Additionally, instillation in the middle ear through perforated eardrums may lead to deafness. If the solution comes into contact with these areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should inform patients that wounds extending beyond the superficial layers of the skin should not be treated routinely with this product. Furthermore, repeated 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 is essential to store the product at a controlled temperature range of 20-25°C (68-77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper storage conditions are crucial for ensuring the efficacy and safety of the product.

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. It is essential to keep the product out of reach of children; if ingested, immediate medical assistance or contact with a Poison Control Center is advised.

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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