Acne Clearing Cleanser

Description

GLYTONE Acne Clearing Cleanser is a therapeutic formulation designed for the management of acne. It contains 2% salicylic acid, a well-established active ingredient known for its efficacy in treating acne. The product is available in a dosage form of 200 mL (6.7 fl. oz).

Uses and Indications

This drug is indicated for the treatment of acne. It effectively dries and clears acne blemishes, facilitating the healing process of the skin. The formulation penetrates pores to eliminate most acne blemishes, including blackheads and whiteheads. Additionally, it aids in preventing the development of new acne blemishes, blackheads, and whiteheads.

Dosage and Administration

Healthcare professionals are advised to dispense a small amount of the product into the hand and mix it with a little water prior to application. A thin layer should be applied over the entire affected area using a circular motion. The area should then be rinsed thoroughly with warm water.

Initially, it is recommended to start with one application daily to minimize the risk of excessive dryness of the skin. If tolerated, the frequency may be gradually increased to two times daily, or as directed by a physician. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion or misuse.

• Discontinue use and consult a healthcare professional if a rash develops, as this may indicate an adverse reaction.

• Contact with the eyes should be avoided; in the event of eye contact, rinse thoroughly with water to mitigate potential irritation.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the application of this product may lead to skin irritation and dryness, particularly if used concurrently with other topical acne medications. In such cases, it is recommended to limit the use to one topical acne treatment at a time to minimize the risk of irritation.

Patients should be cautioned to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water to prevent potential damage.

Should a rash develop during the use of this product, patients are advised to discontinue use immediately and consult a healthcare provider for further evaluation and guidance.

In cases of ingestion, it is critical to seek medical assistance or contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation.

In addition, patients should avoid contact with the eyes. In the event of eye contact, it is recommended to rinse thoroughly with water to alleviate any potential discomfort.

Patients are advised to discontinue use and consult a healthcare professional if a rash occurs. This precaution is essential to ensure the safety and well-being of individuals using the product.

This product is intended for external use only.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the medications 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 Acne Clearing Cleanser (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 contact with a Poison Control Center is recommended.

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

There is no specific information regarding the use of Glytone Acne Clearing Cleanser in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions related to its use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is recommended that pregnant patients consult their healthcare provider for personalized guidance regarding the use of this product during pregnancy.

Lactation

There is no specific information regarding the use of Glytone Acne Clearing Cleanser in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring in this population.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center for expert guidance on managing the situation effectively.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if a rash develops during treatment. It is important to note that skin irritation and dryness may be exacerbated if another topical acne medication is used concurrently. Therefore, patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes. In the case of accidental eye contact, patients should rinse their eyes thoroughly with water to alleviate any potential discomfort.

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 at room temperature, maintaining a range of 68-77°F (20-25°C) to ensure optimal stability and efficacy. Proper handling should be observed to prevent exposure to extreme temperatures, which may compromise the product's integrity.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer over the entire affected area in a circular motion, followed by thorough rinsing with warm water twice daily. To minimize the risk of excessive skin dryness, it is advised to begin with one application daily, gradually increasing to twice daily as necessary or as directed by a healthcare professional. Should patients experience bothersome dryness or peeling, they should reduce the frequency of application to once daily or every other day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)