Xtracare Deep Cleaning Astringent

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided.

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed prior to the application of the medication. A cotton ball or pad should be moistened to facilitate the application, ensuring that a thin layer of the medication covers the entire affected area.

The recommended dosing frequency is 1 to 3 times daily. It is advisable to initiate treatment with one application per day, gradually increasing to 2 to 3 times daily as needed or as directed by a physician. In cases where bothersome drying or peeling occurs, the application frequency should be reduced to once a day or every other day to mitigate these effects.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from open flames. When utilizing this product, it is imperative to avoid contact with the eyes. In the event of contact, the affected area should be immediately flushed with water to mitigate potential irritation.

Healthcare professionals should advise patients that concurrent use of this product with other topical acne medications may exacerbate skin dryness or irritation. If such reactions occur, it is recommended that only one medication be used unless otherwise directed by a physician.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse effects.

Side Effects

Patients should be aware that this product is for external use only and is flammable; it should be kept away from open flames.

When using this product, it is important to avoid contact with the eyes. In the event of contact, patients should immediately flush the eyes with water. Additionally, the concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin. If such reactions occur, it is advised that only one medication be used unless directed otherwise by a healthcare professional.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advisable to limit the use to one medication at a time unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

Below are the non-prescription pack sizes of Xtracare Deep Cleaning Astringent (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children and to use it for external purposes only. Care should be taken to avoid contact with the eyes; in the event of contact, the eyes should be flushed immediately with water.

When treating pediatric patients with this product, it is important to cleanse the skin thoroughly before application. A cotton ball or pad should be moistened and used to cover the entire affected area with a thin layer, applied 1 to 3 times daily. Due to the potential for excessive drying of the skin, it is recommended to start with one application daily, gradually increasing to 2 to 3 times daily as needed or as directed by a physician. If significant drying or peeling occurs, the frequency of application should be reduced to once a day or every other day.

Caution is advised when using this product in conjunction with other topical acne medications, as this may increase skin dryness or irritation. In such cases, only one medication should be used unless otherwise directed by a healthcare professional.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the risk of teratogenic effects associated with its use. Pregnant women should avoid using this product unless directed by a healthcare provider. It is essential for healthcare professionals to counsel women of childbearing potential regarding these risks and to consider alternative treatments when necessary.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is vital for ongoing management and potential reporting requirements.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperatures to maintain its integrity and efficacy. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality is preserved throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Xtracare Deep Cleaning Astringent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)