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 potentially can 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 be thoroughly rinsed with water prior to application. 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 thoroughly once more 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 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.

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 of the potential for serious adverse reactions, particularly related to allergic responses. This product is for external use only and may cause severe allergic reactions in some individuals. Symptoms of such reactions may include 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.

Patients should not use this product if they are allergic to chlorhexidine gluconate or any other ingredient contained in the formulation. Additionally, it should not be applied 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 recommended 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 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 doctor if they experience any signs of irritation, sensitization, or allergic reaction, as these may indicate a serious condition. It is also important to keep this product out of reach of children; if swallowed, 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 of the skin. It is advisable to avoid concurrent use of chlorhexidine gluconate with any chlorine-releasing products to prevent this adverse effect. Monitoring for any signs of staining is recommended if exposure occurs.

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

The product has not been specifically evaluated for use during pregnancy. Currently, there are no explicit statements regarding contraindications or risks to the fetus associated with its use. Additionally, no dosage modifications for pregnant individuals are provided, and there are no special precautions regarding use during pregnancy mentioned in the available data. Healthcare professionals should consider the lack of specific evaluations and exercise clinical judgment when prescribing this product to pregnant patients.

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 available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information 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 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 should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

Nonclinical Toxicology

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

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. 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 avoid contact with the eyes, ears, and mouth while using this product. Emphasize that 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. If the solution does come into contact with these areas, patients should rinse thoroughly and promptly 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 product. 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 product 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 upon request. It should be stored at a controlled room temperature of 20-25ºC (68-77ºF). Care should be taken to avoid exposure to excessive heat, particularly temperatures exceeding 40ºC (104ºF). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use the product with caution in premature infants or infants under 2 months of age, as it may cause irritation or chemical burns. It is also important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center.

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)