Mdacne Customized Acne Cleanser Hydrating Salicylic Acid

Description

This product is identified by the code 51945-4 and is associated with the ID 2276069d-6bab-6baf-e063-6394a90a808a. The effective date of the labeling is September 19, 2024. The package labeling includes a visual representation, referenced as Label06.jpg, which is formatted as a JPEG image.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively clears up acne pimples and blemishes, facilitating skin healing. Additionally, it aids in the prevention of new pimples and blemishes from forming.

There are no teratogenic effects associated with this drug. Furthermore, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to begin by wetting the face. Following this, the product should be gently massaged over the entire face for a duration of 20 to 30 seconds. It is essential to ensure that the product is evenly distributed during this time. After massaging, the face must be rinsed thoroughly with water, and then gently patted dry with a clean towel.

This product is recommended for daily use to achieve optimal results.

Contraindications

Use of this product is contraindicated for prolonged periods without prior consultation with a healthcare professional. This precaution is necessary to ensure patient safety and to mitigate potential risks associated with extended use.

Warnings and Precautions

For external use only. The application of this product may lead to increased dryness or irritation of the skin. To mitigate the risk of excessive drying, it is recommended to initiate treatment with a single daily application. If necessary, the frequency may be gradually increased to twice daily, or as directed by a healthcare professional. Should bothersome dryness or peeling occur, the application frequency should be reduced to once daily.

Prolonged use of this product without medical consultation is not advised. It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate contact with a physician or poison control center is imperative.

Side Effects

The use of this product is intended for external application only. Patients may experience increased dryness or irritation of the skin as a result of its use. Due to the potential for excessive drying, it is recommended that patients begin with a single application daily. If necessary, the frequency may be gradually increased to twice daily, as directed by a healthcare professional. Should patients encounter bothersome dryness or peeling, it is advised to reduce the application frequency to once per day.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mdacne Customized Acne Cleanser Hydrating Salicylic Acid (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is crucial to contact a physician or poison control center immediately for guidance.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 possibility of teratogenic effects. Pregnant women are advised to consult a healthcare provider before using this product. The use of salicylic acid should be avoided during pregnancy unless directed by a healthcare professional.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical attention. If the substance is ingested, the healthcare professional should be contacted without delay, or the individual should reach out to a poison control center for guidance.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to monitor the patient closely for any symptoms that may arise as a result of the overdose. The specific symptoms can vary depending on the substance involved, and appropriate management strategies should be implemented based on clinical presentation and established protocols.

In summary, immediate communication with a physician or poison control center is essential for anyone suspected of experiencing an overdosage, ensuring that timely and effective care is provided.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to contact their physician or a poison control center immediately for guidance.

Additionally, it is important for healthcare providers to emphasize that patients should not use the medication for prolonged periods without first consulting a doctor. This precaution helps to ensure safe and effective use of the medication while minimizing potential risks associated with extended use.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It should be stored in a cool, dry place, maintaining a temperature below 20ºC (70ºF) to ensure stability and efficacy. Proper storage conditions are essential to prevent degradation and maintain the product's quality.

Additional Clinical Information

The product is administered topically and is intended for external use only. Patients should be advised that the use of this product may lead to increased dryness or irritation of the skin. To mitigate excessive drying, it is recommended to start with one application daily, gradually increasing to two times daily if necessary or as directed by a healthcare professional. Should bothersome dryness or peeling occur, patients should reduce the application frequency to once per day. Prolonged use without consulting a physician is not advised.

Clinicians should ensure that patients are aware to keep the product out of reach of children and to seek immediate medical attention if the product is swallowed.

Drug Information (PDF)

This file contains official product information for Mdacne Customized Acne Cleanser Hydrating Salicylic Acid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)