Dermacleanse

Description

DERMACLEANSE™ ACNE GEL is a rapid acne clearing formula designed to address acne-related concerns. This gel is formulated with key active ingredients, including beta hydroxy acid (BHA), Meadowsweet Extract, and Glycolic Acid, which work synergistically to promote clearer skin. The product is vegan and plant-based, aligning with cruelty-free standards, and is certified as such. It is packaged in a 30 ml (1 fl oz) container and is part of the ZENMED® Reconstructive Skincare line.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively reduces the severity of acne blemishes, facilitates the healing of the skin, and helps prevent the formation of new acne blemishes.

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

Dosage and Administration

Healthcare professionals are advised to cleanse the skin thoroughly prior to the application of the medication. The medication should be applied as a thin layer to cover the entire affected area once daily, preferably before bedtime.

Initial treatment should commence with one application per day. Based on the patient's response and as directed by a physician, the frequency of application may be gradually increased to two or three times daily if necessary.

In cases where the patient experiences bothersome dryness or peeling, it is recommended to reduce the frequency of application to once daily or every other day to mitigate these effects.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

This product is intended for external use only. The concurrent use of other topical acne medications, either simultaneously or immediately following the application of this product, may exacerbate skin dryness or irritation. In such cases, it is advised that only one medication be utilized unless otherwise directed by a healthcare professional.

Healthcare providers should exercise caution when considering this product for use in children. It is recommended to consult with a doctor or pharmacist prior to administration in this population.

For individuals who are pregnant or breastfeeding, it is essential to seek guidance from a healthcare professional before using this product to ensure safety for both the mother and child.

Additionally, this product should be stored out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients using this product should be aware that it is for external use only. The concurrent use of other topical acne medications, either simultaneously or immediately following the application of this product, may lead to increased dryness or irritation of the skin. In such cases, it is recommended that only one medication be used unless directed otherwise by a healthcare professional.

Additionally, it is advised that patients consult a doctor or pharmacist before using this product on children. Pregnant or breastfeeding individuals should also seek guidance from a healthcare professional prior to use to ensure safety and appropriateness.

Drug Interactions

Concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin when used simultaneously or immediately after the application of this product. In such cases, it is advisable to limit the use to one topical acne medication 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 Dermacleanse (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should only use this medication under the guidance of a healthcare professional. It is essential to consult a doctor or pharmacist before administering this product to children. Additionally, the medication must be kept out of reach of children to ensure safety and prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of DERMACLEANSE (salicylic acid gel) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for any adverse effects is advisable, given the lack of established guidelines for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with improper access to the medication, ensuring that patients understand the necessity of safeguarding it in their home environment.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from direct light exposure. To maintain the product's quality, it is essential to keep the tube tightly closed when not in use. Additionally, any unused product should be discarded after opening if it is not utilized within a specified time frame.

Additional Clinical Information

The product is administered topically, with a recommended initial application of a thin layer to the entire affected area once daily before bedtime. Patients may gradually increase the frequency to two or three times daily as needed or as directed by a healthcare professional. If bothersome dryness or peeling occurs, patients should reduce the application frequency to once a day or every other day.

Clinicians should advise patients against using other topical acne medications concurrently or immediately after applying this product, as this may exacerbate skin dryness or irritation. It is important for patients to consult a doctor or pharmacist before using the product on children and to seek professional advice if pregnant or breastfeeding.

Drug Information (PDF)

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

View product document (PDF)