Bactoshield Chg

Description

Bactoshield® CHG 2% is a non-sterile surgical scrub containing Chlorhexidine Gluconate at a concentration of 2%. This antimicrobial solution is available in various net contents: 118 mL (4 fl oz), 946 mL (32 fl oz), and 3.78 liters (128 fl oz or 1 gallon). It is intended for single-use and is formulated for healthcare personnel handwashing. The product is manufactured for Deb USA, Inc., located in Charlotte, NC, and is identified by the National Drug Code (NDC) numbers 11084-814-03, 11084-814-24, 11084-814-08, and 11084-814-41. For further information, the product can be accessed through the website www.debmed.com or by contacting 1-866-783-0422.

Uses and Indications

This drug is indicated for surgical hand scrubbing, 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

Healthcare professionals are advised to follow the outlined procedures for dosage and administration of the product in various clinical settings.

For surgical hand scrubs, practitioners should begin by wetting their hands and forearms under running water for 30 seconds. Fingernails must be cleaned using a nailstick or a similar cleaner. Following this, 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 the 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 with wetting the hands with water. Approximately 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, after which it should be 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 cleansing, the area to be cleaned should 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 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.

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

It is essential to keep this product out of reach of children. Ingestion of the product necessitates immediate medical attention or contact with a Poison Control Center.

Care should be taken to avoid contact with the eyes, ears, and mouth, as exposure may result in serious and permanent eye injury if the product is introduced into the eye during surgical procedures. Additionally, instillation into the middle ear through perforated eardrums may lead to deafness. Should the solution come into contact with these sensitive areas, it must be rinsed out promptly and thoroughly with water.

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

Side Effects

Patients using this product should be aware of the potential for serious adverse reactions, particularly 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 to discontinue use immediately and seek medical assistance.

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

During use, it is crucial 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. Should the solution come into contact with these sensitive areas, it must be rinsed out promptly and thoroughly with water. Additionally, wounds that extend beyond the superficial layers of the skin should not be treated routinely 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 advised to stop using the product and consult a healthcare professional if they experience irritation, sensitization, or any signs of an allergic reaction, as these may indicate a serious condition. Furthermore, this product should be kept out of reach of children, and in the event of ingestion, medical help or contact with a Poison Control Center should be sought immediately.

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 essential for healthcare providers to assess the patient's allergy history prior to administration to mitigate the risk of an adverse reaction.

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 indicated. However, clinicians should remain vigilant and consider the overall clinical context when prescribing this product.

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 or under 2 months of age, as these populations may experience increased sensitivity. The potential for irritation or chemical burns necessitates caution in administration. It is advisable to consider dose adjustments and enhanced monitoring for geriatric patients to ensure safety and efficacy.

Pregnancy

There are no specific statements regarding the use of Bactoshield CHG during pregnancy. The available data does not indicate 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 recommended. Healthcare professionals should consider the absence of specific pregnancy-related information when advising women of childbearing potential regarding the use of Bactoshield CHG.

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 infants in these vulnerable age groups.

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 drug. Consequently, there are no 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 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 potential for severe allergic reactions associated with this product. Reported 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 advised to discontinue use and seek immediate medical assistance.

Additionally, users are cautioned to stop use and consult a healthcare professional if signs of irritation, sensitization, or allergic reactions occur, as these may indicate a serious condition.

Special care should be taken when using this product in premature infants or infants under 2 months of age, as it may lead to irritation or chemical burns.

Furthermore, this product contains coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause certain health risks. 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. Instruct patients that if the product is swallowed, they 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 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 with water as soon as possible.

Healthcare providers should also caution patients against routinely treating wounds that extend beyond the superficial layers of the skin. Furthermore, 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 is essential to store the product at a temperature range of 20 to 25°C (68 to 77°F). Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). 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 Bactoshield Chg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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