Bactoshield Chg

Description

Bactoshield® CHG 4% is a non-sterile surgical scrub containing 4% chlorhexidine gluconate, an antimicrobial agent. It is available in various net contents: 118 mL (4 fl oz), 473 mL (16 fl oz), 946 mL (32 fl oz), and 3.78 liters (128 fl oz or 1 gallon). Each formulation is intended for single use and is identified by the following National Drug Codes (NDC): 11084-815-03, 11084-815-34, 11084-815-24, and 11084-815-08. The product is designed for effective antiseptic cleansing in surgical settings.

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 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 healthcare professional to first wet their 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 is given 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. The process should be repeated with an additional 5 ml of the product, scrubbing for another 3 minutes before rinsing under running water. It is essential to dry the hands and forearms thoroughly after completion.

For healthcare personnel handwashing, the individual should wet their hands with water and dispense about 5 ml of the product into cupped hands. A vigorous washing technique should be employed for a minimum of 15 seconds, followed by thorough rinsing and drying.

In the context 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, after which it should be dried with a sterile towel. This procedure should be repeated for an additional 2 minutes, followed by drying with another sterile towel.

For skin wound and general skin cleansing, the area to be cleaned should first be thoroughly rinsed with water. The minimum amount of product necessary to adequately cover the skin or wound area should then be applied, followed by gentle washing. A thorough rinse is required to complete the cleansing 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.

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, particularly if the product is introduced during surgical procedures. Additionally, instillation into the middle ear through perforated eardrums may lead to deadness. 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. Furthermore, repeated cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

In the case 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, patients are advised to discontinue use immediately and seek medical assistance.

Common adverse reactions include irritation, sensitization, or allergic reactions. Should any of these symptoms occur, it is recommended that patients stop using the product and consult a healthcare provider, as these may indicate a serious condition.

In clinical settings, caution is advised regarding the use of this product in specific areas. It should not be used if the patient is allergic to chlorhexidine gluconate or any other ingredient in the formulation. Additionally, the product should not come into contact with the meninges or be applied in the genital area. It is also contraindicated for use as a preoperative skin preparation on the head or face.

When 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 other complications, such as deadness 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

This product has the potential to induce a severe allergic reaction in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. It is imperative that healthcare providers assess patients for any history of hypersensitivity to these ingredients prior to administration.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring for interactions with other medications or laboratory tests is not necessary unless otherwise indicated by the patient's clinical condition.

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 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 individual patient's condition and adjust the dosage as necessary to ensure safety and efficacy.

Pregnancy

Pregnant patients should be aware that there are no specific safety concerns or special precautions regarding the use of this medication during pregnancy as per the available data. Additionally, there are no dosage modifications indicated for pregnant individuals. Healthcare professionals should consider the absence of explicit statements regarding safety when prescribing this medication to women of childbearing potential. As always, the benefits and risks should be carefully weighed in the context of individual patient circumstances.

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 addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 use of the compound in question.

Postmarketing Experience

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

Furthermore, it is important to note that this product may expose users to coconut oil diethanolamine condensate (cocamide diethanolamine), a substance recognized by the State of California as a potential carcinogen. For further information, individuals are directed to visit www.P65Warnings.ca.gov.

Patient Counseling

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

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

When using this product, it is crucial to instruct patients to avoid contact with the eyes, ears, and mouth. The product may cause serious and permanent eye injury if it comes into contact with the eye during surgical procedures, or may lead to complications if instilled in the middle ear through perforated eardrums. If the solution accidentally contacts these areas, patients should rinse them promptly and thoroughly with water.

Additionally, patients should be cautioned that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. 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, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

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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