Bactoshield Chg

Description

SCJ Professional Bactoshield is a surgical scrub containing 4% chlorhexidine gluconate (CHG) as its active ingredient. This antiseptic solution is formulated for antimicrobial use in surgical settings. The product is presented in a liquid dosage form with a net content of 32 fluid ounces (946 mL). It is manufactured for SCJ Professional USA, Inc., located in Charlotte, NC 28217. The product is associated with the National Drug Code (NDC) 11084-039-24. Users are advised to keep the solution from freezing and to be aware of the warning regarding cancer, as noted on www.P65Warnings.ca.gov. For further information, contact 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 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 suitable for skin wound and general skin cleansing.

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

Dosage and Administration

Surgical hand scrubbing requires the following procedure: Healthcare professionals should begin by wetting their hands and forearms with water. Approximately 5 mL of the product should be applied using a wet brush, ensuring a thorough scrub for 3 minutes, with particular attention to the nails, cuticles, and interdigital spaces. A separate nail cleaner may be utilized if necessary. Following the initial scrub, hands and forearms must be rinsed thoroughly. An additional wash with 5 mL of the product should be performed for another 3 minutes, followed by rinsing under running water. It is essential to dry hands and forearms thoroughly after this process.

For healthcare personnel handwashing, the procedure involves wetting the hands with water and dispensing about 5 mL of the product into cupped hands. Hands should be washed vigorously for 15 seconds, followed by thorough rinsing and drying.

When cleaning skin wounds or for 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 final thorough rinse is required to complete the cleaning process.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to chlorhexidine gluconate or any other component of the formulation. Additionally, the product should not be applied in contact with the meninges due to the potential for serious adverse effects. It is also contraindicated for use in the genital area to prevent irritation or other complications.

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 or potential deafness if introduced into 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 ingestion, immediate medical help should be sought, or a Poison Control Center should be contacted without delay.

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, which can be categorized by seriousness and frequency.

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. It is crucial 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.

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

Additionally, caution is advised when using this product. It should not come into contact with the meninges or be applied in the genital area. 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 potential deafness if the solution is instilled in the middle ear through perforated eardrums. If contact occurs, the affected area should be rinsed promptly and thoroughly with water.

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 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 use this product with caution. There is a risk of irritation or chemical burns associated with its use in this population. Healthcare professionals are advised to closely monitor these patients to mitigate potential adverse effects.

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 assess the risks and benefits of treatment in geriatric patients, ensuring that appropriate safety measures are in place. Regular monitoring for adverse effects is recommended to mitigate any potential complications associated with the use of this medication in the elderly population.

Pregnancy

The safety of chlorhexidine gluconate during pregnancy has not been established. While there are no specific contraindications for its use in pregnant patients, caution is advised. Healthcare providers should be consulted prior to use to assess the potential risks and benefits for both the mother and the developing fetus.

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 text 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 and monitoring of these patients.

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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 these contexts.

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 seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is essential to inform patients not to use the product if they have a known allergy to chlorhexidine gluconate or any other ingredient contained in the formulation.

Patients should be cautioned against using the product in contact with the meninges or in the genital area. Healthcare providers should instruct patients 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, patients must be reminded to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or potential deafness if the solution enters the middle ear through perforated eardrums. In the event of contact with these areas, patients should rinse thoroughly and promptly with water.

Healthcare providers should also inform patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this product. Additionally, 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

The product is administered topically. Clinicians should counsel patients 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. In the event of contact with these areas, patients should rinse thoroughly with water.

Patients should be advised against the routine treatment of wounds that extend beyond the superficial layers of the skin and to refrain from repeated general skin cleansing of large body areas unless directed by a healthcare provider. They should discontinue use and consult a doctor if any signs of irritation, sensitization, or allergic reaction occur, as these may indicate a serious condition. In case of ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

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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