Acne Advanced Clarifying Masque

Description

The Acne Advanced Clarifying Masque is presented in a 2 oz box, identified by the code 15751-3020-2. The product is effective as of November 13, 2018. It is associated with a media type of image/jpeg, with a reference to the label file labeled as Label2.jpg.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with this condition to help reduce the severity and prevalence of acne lesions.

Dosage and Administration

Healthcare professionals should instruct patients to cleanse the skin thoroughly prior to application of the product. A small amount should be applied evenly over the entire face or utilized as a spot treatment as desired. The product should be allowed to dry for a duration of 5 to 10 minutes. Following this, it is recommended to rinse the skin thoroughly with lukewarm water, using a face cloth if preferred.

For treatment frequency, the product may be used weekly as a masque or as a spot treatment up to three times per day. It is advisable to initiate treatment with one application daily, gradually increasing to two or three times daily as needed or as directed by a healthcare provider. Should excessive drying or peeling of the skin occur, patients should reduce the frequency of application to once a day or every other day.

Contraindications

Use of this product is contraindicated in the eye area. In the event of contact with the eyes, it is essential to flush gently and thoroughly with water to mitigate potential irritation. No other contraindications have been identified.

Warnings and Precautions

For external use only. The application of this product may lead to skin irritation and dryness, particularly when used concurrently with other topical acne treatments. To minimize the risk of irritation, it is advisable to use only one topical product at a time.

Care should be taken to avoid contact with the eye area. In the event of accidental eye contact, it is essential to flush the eyes gently and thoroughly with water to mitigate potential harm.

Ingestion of the product requires immediate medical attention. If swallowed, it is imperative to seek medical help or contact the Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is for external use only. The use of this product in conjunction with other topical acne treatments may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients use only one product at a time to minimize adverse effects.

Care should be taken to avoid contact with the eye area. Should contact occur, patients are advised to flush the eyes gently and thoroughly with water to alleviate any potential discomfort.

Additionally, if the product is ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

The concurrent use of topical acne products may increase the likelihood of skin irritation and dryness. It is advisable to avoid simultaneous application of multiple topical acne treatments. In the event that irritation occurs, it is recommended to discontinue the use of one product to minimize adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Acne Advanced Clarifying Masque (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, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Acne Advanced Clarifying Masque in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this population.

Pregnancy

The product has not been specifically evaluated for use during pregnancy. Salicylic acid, the active ingredient, is generally advised to be used with caution during this period due to potential risks to the fetus. The use of salicylic acid in high doses or systemic forms is contraindicated in pregnant patients. It is recommended that women who are pregnant or planning to become pregnant consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

The safety of this product has not been established in nursing mothers. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to lactating mothers.

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 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact the Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 seek immediate medical assistance or contact the Poison Control Center if the product is swallowed.

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

Providers should also emphasize the importance of avoiding contact with the eye area. In the event of accidental eye contact, patients should be instructed to flush the eyes gently and thoroughly with water.

Storage and Handling

The product is supplied in a container that must be stored in controlled temperatures ranging from 4 to 20°C (39 to 68°F). It is essential to keep the product in a dark and dry place to maintain its integrity. The container should remain tightly closed when not in use to prevent contamination. Additionally, the product should not be used if the seal under the cap is broken or missing, as this may compromise its safety and efficacy.

Additional Clinical Information

The product is administered topically, with recommendations for use as a masque on a weekly basis or as a spot treatment up to three times daily. To minimize the risk of excessive skin drying, patients should begin with one application daily, gradually increasing to two or three times daily as needed or directed by a healthcare professional. If significant dryness or peeling occurs, patients are advised to reduce the frequency of application to once daily or every other day.

Clinicians should counsel patients on the potential for skin irritation and dryness, particularly when using other topical acne treatments concurrently. It is important to avoid the eye area; in the event of contact, the eyes should be flushed gently and thoroughly with water. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

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

View product document (PDF)