Gly-Sal 5-2

Description

Gly/Sal 5-2 is a pore refining cleanser formulated with 5% glycolic acid and 2% salicylic acid USP. This product is designed to effectively cleanse the skin while promoting exfoliation and refining the appearance of pores. It is presented in a net volume of 6.7 fluid ounces (200 milliliters).

Uses and Indications

This drug is indicated as a skin cleanser for the treatment of acne. It is intended for use in patients with acne vulgaris to help reduce the severity and frequency of acne lesions.

Dosage and Administration

The affected area should be wetted prior to application. The product is to be applied directly to the area and rinsed thoroughly afterward.

Initial treatment should begin with one application per day. 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 occurs, it is recommended to reduce the application frequency to once daily or every other day.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes, lips, and mouth to prevent irritation or adverse reactions.

Healthcare professionals should advise patients that the concurrent use of other topical medications while using this product, or immediately thereafter, may exacerbate dryness or irritation. Should such symptoms occur, patients are instructed to discontinue use and consult their healthcare provider for further evaluation.

This product must be kept out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Additionally, the use of sunscreen is strongly advised when utilizing any glycolic acid product, as well as for at least one week following discontinuation. This precaution is particularly important as some individuals may exhibit increased sensitivity to sunlight.

Side Effects

Patients using this product should be aware that it is for external use only and must be kept away from the eyes, lips, and mouth. The use of other topical medications concurrently or immediately after applying this product may lead to increased dryness or irritation. In such cases, patients are advised to discontinue use and consult their healthcare provider.

It is crucial to keep this product out of the reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact should be made with a Poison Control Center.

Additionally, it is recommended that patients use sunscreen in conjunction with any glycolic acid product and for at least one week following its use, as some individuals may exhibit heightened sensitivity to sunlight.

Drug Interactions

The concurrent use of other topical medications while using this product, or immediately thereafter, may lead to increased dryness or irritation of the skin. In such cases, it is advised to discontinue use of the product and consult a healthcare professional for further evaluation and management. Monitoring for signs of skin irritation is recommended to ensure patient safety and comfort.

Packaging & NDC

Below are the non-prescription pack sizes of Gly-Sal 5-2 (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely to ensure the product is kept out of their reach. 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. Depending on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily. Care should be taken to avoid excessive drying of the skin; if bothersome dryness occurs, the application frequency should be reduced to once a day or every other day.

Geriatric Use

There is no specific information regarding the use of Gly-Sal 5-2 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, including comorbidities and concurrent medications. Monitoring for potential adverse effects is advisable in this population, given the general increased sensitivity of elderly patients to medications.

Pregnancy

There are no specific warnings or precautions regarding the use of Gly-Sal 5-2 during pregnancy. The available information does not indicate whether the product is contraindicated in pregnancy or if there are any risks to the fetus associated with its use. Additionally, no dosage modifications or special precautions for pregnant individuals are provided. Healthcare professionals should consider the lack of data when prescribing Gly-Sal 5-2 to pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may not need to take special precautions when prescribing this medication to lactating mothers.

Renal Impairment

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

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 event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and provide supportive care as necessary.

Management of overdosage typically involves symptomatic treatment and may require specific interventions based on the clinical presentation. It is crucial to follow established protocols for the management of overdose cases, which may include activated charcoal administration if appropriate and within the recommended time frame, as well as other supportive measures tailored to the patient's needs.

Prompt recognition and intervention are key to minimizing potential complications associated with 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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help immediately or contact a Poison Control Center for assistance. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is topical. Clinicians should advise patients to use sunscreen when using any glycolic acid product and for an additional week following its use, as some individuals may exhibit increased sensitivity to sunlight.

Drug Information (PDF)

This file contains official product information for Gly-Sal 5-2, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)