Foster and Thrive

Description

This product is an antiseptic skin cleanser containing Chlorhexidine Gluconate at a concentration of 4%. It is formulated as a dye-free solution intended for external use only. The product is packaged in an 8 fluid ounce (237 mL) container. The National Drug Code (NDC) for this formulation is 70677-1221-1. It is comparable to the active ingredient found in Hibiclens®.

Uses and Indications

This drug is indicated for use in healthcare personnel handwashing to help reduce bacteria that may potentially cause disease. It is also indicated for skin wound care and general skin cleansing.

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

Dosage and Administration

Healthcare personnel should begin by wetting their hands with water. Approximately 5 mL of the product should be dispensed into cupped hands, followed by vigorous washing for about 15 seconds. After washing, hands must be rinsed thoroughly and dried.

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. The area must be rinsed again thoroughly to ensure complete removal of the product.

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 risk of serious complications. It is also contraindicated for use in the genital area to prevent potential adverse effects.

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.

This product should not be used in the following circumstances:

• If the patient has a known allergy to chlorhexidine gluconate or any other component of this formulation.

• If there is potential contact with the meninges.

• In the genital area.

When utilizing this product, it is essential to avoid contact with the eyes, ears, and mouth, as exposure may lead to serious and permanent eye injury or deafness if introduced into the middle ear through perforated eardrums. Should the solution inadvertently contact these 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. Repeated general skin cleansing of large body areas is discouraged unless specifically advised by a healthcare provider.

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.

It is crucial to keep this product out of reach of children. In the event of ingestion, immediate medical attention 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 significant risk of 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. Additionally, it is contraindicated for use in contact with the meninges or in the genital area.

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 potential deafness if instilled in the middle ear through perforated eardrums. Should the solution come into contact with these areas, it is imperative to rinse thoroughly with water. Furthermore, wounds that extend beyond the superficial layers of the skin should not be routinely treated with this product, and repeated cleansing of large body areas should only be performed under the guidance of a healthcare provider.

Patients should discontinue use and consult a physician if they experience any signs of irritation, sensitization, or allergic reactions, as these may indicate a serious condition. It is also important to keep this product out of reach of children; if ingested, immediate medical help or contact with a Poison Control Center is necessary.

Drug Interactions

Chlorhexidine gluconate skin cleanser may interact with chlorine-releasing products, including chlorine bleach. The combination of these agents can lead to staining. It is advisable to avoid concurrent use of chlorhexidine gluconate with any chlorine-releasing products to prevent this adverse effect. No specific dosage adjustments or monitoring parameters are indicated; however, caution is recommended when using these products in proximity to one another.

Packaging & NDC

Below are the non-prescription pack sizes of Foster and Thrive (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 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. Regular assessment of the patient's condition and response to treatment is recommended to ensure safety and efficacy.

Pregnancy

Pregnant patients should be advised to use this product with caution, particularly in the context of premature infants or infants under 2 months of age. There is a potential risk of irritation or chemical burns associated with the use of this product in these vulnerable populations. Healthcare professionals are encouraged to weigh the benefits against the risks when considering the use of this product in pregnant patients, especially those who may be at risk of exposure to premature or very young infants.

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

Postmarketing Experience

Postmarketing experience has identified potential signs of a serious condition associated with the use of the product. Additionally, it has been noted that chlorhexidine gluconate skin cleanser may cause staining when used in conjunction with chlorine-releasing products, such as chlorine bleach. These observations have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to avoid contact with the eyes, ears, and mouth, as the medication may cause serious and permanent eye injury if it enters the eye, or may lead to deafness if instilled in the middle ear through perforated eardrums. If the solution comes into contact with these areas, patients should rinse them promptly and thoroughly with water.

It is important to counsel patients that wounds involving more than the superficial layers of the skin should not be routinely treated with this medication. Additionally, repeated general skin cleansing of large body areas should only be performed when specifically advised by a healthcare provider.

Patients should be instructed to stop using the medication and consult a doctor if they experience any irritation, sensitization, or allergic reactions, as these may indicate a serious condition.

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 20-25ºC (68-77ºF). Care should be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40ºC (104ºF). Proper storage conditions are crucial to maintain the integrity and efficacy 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 crucial to avoid contact with the eyes, ears, and mouth, as exposure can lead to serious and permanent eye injury or potential deafness if instilled in the middle ear through perforated eardrums. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Foster and Thrive, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)