Gly-Sal 10-2

Description

Gly / Sal 10-2 Pads contain Glycolic Acid at a concentration of 10% and Salicylic Acid USP at 2%. Each container includes 60 pads designed for topical application. These active ingredients are formulated to provide exfoliating and acne treatment properties.

Uses and Indications

This drug is indicated for the treatment of acne through the use of cleansing pads that incorporate the skin enhancement properties of Glycolic acid.

There are no teratogenic or nonteratogenic effects associated with this product, making it suitable for use without specific restrictions related to these concerns.

Dosage and Administration

The affected area should be wiped with a moist pad one to three times daily. Treatment should begin with one application per day, with the frequency gradually increased to two or three times daily as needed or as directed by a physician. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once daily or every other day.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. If swallowed, immediate professional assistance or contact with a Poison Control Center is necessary.

The product is flammable; therefore, it must be kept tightly closed and stored away from flames and heat sources to prevent fire hazards.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid contact with the eyes, lips, and mouth to prevent irritation. Should any irritation develop during use, it is advised to discontinue application immediately and consult a healthcare professional for further guidance.

Concurrent use of other topical acne medications may exacerbate skin dryness or irritation. In such cases, it is recommended to limit the use to one topical medication unless otherwise directed by a healthcare provider.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek professional medical assistance or contact a Poison Control Center without delay.

Due to its flammable nature, the product should be stored tightly closed and kept away from flames and heat sources to prevent fire hazards.

Additionally, the use of sunscreen is strongly recommended when using any Glycolic Acid product, as well as for at least one week following its use. This precaution is particularly important for individuals who 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. In the event that irritation develops, it is advised to discontinue use and consult a healthcare professional. The concurrent use of other topical acne medications may exacerbate dryness or irritation of the skin; therefore, it is recommended that only one medication be used at a time unless otherwise directed by a physician.

In cases where the product is ingested, patients should seek professional assistance or contact a Poison Control Center immediately. Additionally, the product is flammable; it should be kept tightly closed and stored away from flames and heat sources.

It is important to note that the use of sunscreen is recommended while using any Glycolic Acid product and for an additional week thereafter, as some individuals may exhibit increased sensitivity to sunlight.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advisable to limit the use to one medication at a time 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 Gly-Sal 10-2 (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, it is crucial to seek professional assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information regarding the use of Gly-Sal 10-2 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 and potential risks. Monitoring for adverse effects and therapeutic efficacy is recommended in this population, given the general considerations for pharmacotherapy in older adults.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of Gly-Sal 10-2 in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of Gly-Sal 10-2 in nursing mothers without specific concerns noted in the prescribing information.

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

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 specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is imperative that healthcare professionals take immediate action. If the substance is ingested, the first step is to seek professional assistance or contact a Poison Control Center without delay.

Prompt intervention is crucial 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 essential to ensure patient safety and to address any complications that may arise during the management of an overdosage situation.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek professional assistance or contact a Poison Control Center immediately.

It is important to inform patients that the product is flammable. They should be instructed to keep the container tightly closed and store it away from flames and heat sources to prevent any accidents.

Additionally, healthcare providers should recommend the use of sunscreen when using any Glycolic Acid product. Patients should be made aware that they may be more sensitive to sunlight and should continue using sunscreen for an additional week after discontinuing the product to protect their skin from potential sun damage.

Storage and Handling

The product is classified as flammable and must be stored in a tightly closed container, away from any sources of flame and heat. It is recommended to maintain storage conditions at room temperature to ensure product integrity and safety.

Additional Clinical Information

Patients should apply the product by wiping the entire affected area with a moist pad one to three times daily. It is advisable to start with one application daily and gradually increase to two or three times daily as needed or as directed by a physician. If patients experience bothersome dryness or peeling, they should reduce the application frequency to once a day or every other day.

Clinicians should counsel patients on the importance of using sunscreen while using any Glycolic Acid product and for an additional week thereafter, as some individuals may exhibit increased sensitivity to sunlight.

Drug Information (PDF)

This file contains official product information for Gly-Sal 10-2, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)