Gly-Sal 10-2

Description

Gly/Sal 10-2 Spray is a topical formulation containing 10% Glycolic Acid and 2% Salicylic Acid USP. This product is designed for dermatological use and is presented in a net volume of 3 fluid ounces (89 milliliters). The combination of these active ingredients is intended to provide exfoliating and acne treatment properties.

Uses and Indications

This drug is indicated for the treatment of acne of the body, leveraging the skin enhancement properties of glycolic acid.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The affected area should be sprayed one to three times daily, depending on the severity of the condition and the patient's response to treatment. It is recommended to initiate therapy with one application per day to minimize the risk of excessive skin drying. Based on the patient's tolerance and clinical response, the frequency may be gradually increased to two or three times daily, as directed by a healthcare professional.

In cases where bothersome dryness or peeling occurs, it is advisable to reduce the application frequency to once daily or every other day. Healthcare professionals should monitor the patient's skin condition and adjust the dosing regimen accordingly to ensure optimal therapeutic outcomes while minimizing adverse effects.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate professional assistance or contact with a Poison Control Center is advised.

• Due to its flammable nature, the product must be stored tightly closed and away from flames and heat sources to mitigate fire hazards.

Warnings and Precautions

For external use only. It is imperative that the product is applied with caution, ensuring that the spray is directed away from the face, particularly the eyes, lips, and mouth, to prevent accidental exposure. In the event that irritation develops, the use of the product should be discontinued immediately, and a healthcare professional should be consulted for further evaluation and guidance.

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

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

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

Additionally, the use of sunscreen is recommended when using any Glycolic Acid product and for at least one week following its use, as some individuals may exhibit increased sensitivity to sunlight. Regular monitoring of skin reactions and adherence to these precautions will help ensure safe and effective use of the product.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only. Users are advised to direct the spray away from the face, particularly avoiding contact with the eyes, lips, and mouth. In the event that irritation develops, it is recommended to discontinue use and consult a healthcare professional.

Concurrent use of other topical acne medications may exacerbate skin dryness or irritation. If such reactions occur, it is advisable to limit the use to one medication unless otherwise directed by a physician.

In cases of accidental ingestion, patients should seek professional assistance or contact a Poison Control Center immediately. The product is flammable; therefore, it should be kept tightly closed and stored away from flames and heat sources.

Additionally, the use of sunscreen is recommended while using any Glycolic Acid product and for at least one week following its use, 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

Safety during pregnancy has not been established for this medication. It is not recommended for use during pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this medication 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, there are no specific considerations or precautions related to lactation mentioned in the provided text.

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 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 professional assistance without delay. Healthcare professionals should be contacted immediately, or the individual should be directed to a Poison Control Center for guidance.

Symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is crucial for healthcare providers to assess the patient's condition thoroughly and monitor for any adverse effects that may arise.

Management of overdosage should be initiated promptly. This may include supportive care and symptomatic treatment as necessary. The specific interventions will depend on the clinical presentation and the substance involved. Continuous monitoring of the patient's vital signs and overall status is essential to ensure appropriate care and intervention.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should be instructed to seek professional assistance or contact a Poison Control Center immediately.

It is important to inform patients that the product is flammable. They should be cautioned to keep the container tightly closed and store it away from flames and heat sources to minimize any risk of fire.

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 at room temperature to ensure product integrity and safety.

Additional Clinical Information

The product is administered topically, with the recommended application being one to three times daily. Patients should begin with one application daily and may gradually increase to two or three times daily as needed or directed by a physician. If bothersome dryness or peeling occurs, it is advised to reduce the frequency to once a day or every other day.

Clinicians should counsel patients to direct the spray away from the face, particularly the eyes, lips, and mouth. If irritation develops, patients should discontinue use and consult a doctor. Caution is advised when using other topical acne medications concurrently, as this may exacerbate dryness or irritation; only one medication should be used unless otherwise directed by a physician. Additionally, the use of sunscreen is recommended while using this product and for an additional week thereafter, as some individuals may experience 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)