Replenix Gly-Sal 10-2

Description

REPLENiX® ACNE SOLUTIONS Gly/Sal® 10-2 Cleanser is a topical formulation designed for the management of acne. The product contains Glycolic Acid at a concentration of 10% and Salicylic Acid USP at 2%, both of which are known for their efficacy in exfoliating the skin and promoting cellular turnover. The cleanser is packaged in a net volume of 6.7 fluid ounces (200 milliliters). It is manufactured by Topix Pharmaceuticals, Inc., located in North Amityville, NY 11701.

Uses and Indications

This drug is indicated as a skin cleanser for the treatment of acne.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

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 commence 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

Use of this product is contraindicated in the following situations:

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

• In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 against the concurrent use of other topical medications while using this product or immediately thereafter, as this 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 an additional week following its use. 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.

In clinical practice, the use of this product in conjunction with other topical medications may lead to increased dryness or irritation. Should such reactions occur, it is advised to discontinue use and consult a healthcare professional.

Additionally, 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 a Poison Control Center.

Furthermore, the use of sunscreen is recommended while using this product and for an additional week thereafter, 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 Replenix Gly-Sal 10-2 (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought or a Poison Control Center contacted.

For topical application, it is recommended to initiate treatment with one application daily. Dosage may be gradually increased to two or three times daily as needed or as directed by a physician. Care should be taken to monitor for excessive drying of the skin; if bothersome dryness occurs, the frequency of application should be reduced to once a day or every other day.

Geriatric Use

Elderly patients may not have specific information regarding the use of Replenix Gly-Sal 10-2 Cleanser, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, considering the absence of targeted data. Monitoring for any adverse effects or unusual responses in elderly patients is advisable, given the lack of established guidelines for this demographic.

Pregnancy

There is no specific information available regarding the use of Replenix Gly-Sal 10-2 Cleanser during pregnancy. As such, safety concerns, dosage modifications, or special precautions for pregnant patients have not been established in the provided drug insert. 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 before using this product.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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

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 based on individual patient circumstances.

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 is 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 should include symptomatic treatment and monitoring of vital signs. It is crucial to follow established protocols for the specific substance involved, which may include activated charcoal administration if appropriate and within the recommended time frame post-ingestion.

In all cases of suspected overdosage, prompt intervention and adherence to local guidelines for poison management are critical to ensure patient safety and effective treatment outcomes.

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 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 and their families.

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 to continue its use for an additional week afterward, as some individuals may exhibit increased sensitivity to sunlight.

Drug Information (PDF)

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

View product document (PDF)