Enfuselle Acne Clarifying

Description

This paraben-free salicylic acid acne treatment is designed for all skin types and comes in a 1 fl. oz. (29 mL) container, providing approximately 120 applications. The formulation features a breakthrough patented formula that combines nourishing antioxidants and purifying botanicals to address the factors contributing to acne-prone skin. Key botanical extracts include tea tree (Melaleuca alternifolia) oil, manuka (Leptospermum scoparium) oil, licorice (Dipotassium glycyrrhizate) extract, burdock (Arctium lappa) root extract, watercress (Nasturtium officinale) extract, and aloe vera (Aloe barbadensis) leaf juice.

Additionally, the product is enriched with antioxidant vitamins A and E, and is clinically formulated and dermatologist tested. It is gentle enough for daily use, promoting the normalization of sebum production, unclogging of pores, speeding healing, and reducing redness associated with acne. The treatment is allergy tested and is recommended to be stored at temperatures not exceeding 100°F. U.S. Patent 6,403,110 applies to this formulation. With continued use, the skin is expected to become visibly smoother, clearer, and free of shine.

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 cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer.

Initially, it is advised to apply the product once daily. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily.

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

Contraindications

There are no specific contraindications listed for this product. However, it is advised to avoid contact with the eyes. In the event of contact, rinse thoroughly with water to remove the product.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is strongly recommended.

Patients should be instructed to discontinue use and consult their healthcare provider if they experience any adverse effects, although specific instructions for cessation are not provided in the current guidelines.

General precautions must be observed to minimize the risk of skin irritation and dryness. The concurrent use of this product with other topical acne medications may increase the likelihood of these adverse effects. Therefore, it is advisable to use only one topical acne medication at a time to prevent irritation.

Additionally, care should be taken to avoid contact with the eyes. In the event of accidental exposure, the affected area should be rinsed thoroughly with water to ensure complete removal of the product.

Side Effects

Patients should be aware that the product is intended for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

It is essential for patients to monitor for any unexpected effects and to consult healthcare professionals if they experience any adverse reactions while using the product.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate these effects, it is advised to limit the use to one topical acne medication at a time. If irritation occurs, discontinuation of additional topical agents is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Enfuselle Acne Clarifying (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For topical application, it is recommended to initiate treatment with one application daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two or three times daily as needed or directed by a healthcare professional. Should patients experience bothersome dryness or peeling, the frequency of application should be reduced to once a day or every other day.

Geriatric Use

There is no specific information 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 product has not been specifically evaluated for use during pregnancy. Currently, there are no explicit warnings or contraindications associated with the use of this product in pregnant patients. Additionally, the prescribing information does not provide any dosage modifications for individuals who are pregnant. Furthermore, no special precautions regarding the use of this product during pregnancy are indicated. Healthcare professionals should consider the lack of specific data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks.

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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported, and there is no available information regarding animal pharmacology and toxicology. The compound has not been tested in animal studies, and therefore, no data on nonclinical toxicology is available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed.

It is important to inform patients that the use of this medication in conjunction with other topical acne treatments may increase the likelihood of skin irritation and dryness. Therefore, patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation.

Patients should also be reminded to avoid contact with the eyes. In the event of accidental contact, they should rinse their eyes thoroughly with water to remove the medication.

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 in a controlled environment, ensuring that temperatures do not exceed 100°F. Proper storage conditions are critical to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the medication one to three times daily after cleansing and toning. Clinicians are advised to counsel patients that if irritation occurs, only one topical acne medication should be used at a time. In cases of bothersome dryness or peeling, patients may reduce the application frequency to once a day or every other day.

Drug Information (PDF)

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

View product document (PDF)