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Gly-Sal 10-2 Pads

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Active ingredient
Salicylic Acid 0.02 g
Other brand names
Dosage form
Cloth
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2000
Label revision date
October 23, 2019
Active ingredient
Salicylic Acid 0.02 g
Other brand names
Dosage form
Cloth
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2000
Label revision date
October 23, 2019
Manufacturer
Topiderm, Inc.
Registration number
M006
NDC root
51326-039

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If you are a consumer or patient please visit this version.

Drug Overview

REPLENiX® ACNE SOLUTIONS are cleansing pads designed to help treat acne while also enhancing your skin. These pads contain Glycolic Acid (a type of alpha hydroxy acid that helps exfoliate the skin) at a concentration of 10%, as well as Salicylic Acid (a beta hydroxy acid that helps unclog pores) at 2%. Together, these ingredients work to improve your skin's appearance and reduce acne breakouts.

Each package contains 60 pads, making it easy to incorporate into your daily skincare routine. Manufactured by Topix Pharmaceuticals, these pads are formulated to provide effective acne treatment while promoting healthier skin.

Uses

If you're looking for a solution to help manage acne, these cleansing pads could be a great option for you. They are specifically designed to treat acne while also enhancing your skin's appearance, thanks to the inclusion of glycolic acid. Glycolic acid is known for its ability to exfoliate the skin, helping to clear away dead skin cells and promote a healthier complexion.

You can feel confident using these pads, as there are no reported teratogenic effects (which means they don't cause birth defects) or nonteratogenic effects associated with them. This makes them a safe choice for many individuals seeking to improve their skin health.

Dosage and Administration

To use this medication effectively, start by wiping the entire affected area with a moist pad once a day. After a few days, if you feel comfortable and your physician recommends it, you can gradually increase the application to two or three times daily.

It's important to pay attention to how your skin reacts. If you notice any bothersome dryness or peeling, reduce the frequency of application to once a day or even every other day. This way, you can find the right balance that works for your skin while still benefiting from the treatment.

What to Avoid

It's important to be aware of certain guidelines when using this product. If you experience any irritation while using it, you should stop using the product immediately and consult your doctor for further advice.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. Always prioritize your health and safety by following these instructions closely.

Side Effects

You should be aware that this product is for external use only and should be kept away from your eyes, lips, and mouth. If you experience any irritation while using it, it's important to stop using the product and consult a doctor. Additionally, using other topical acne medications at the same time may increase skin dryness or irritation, so it's best to use only one unless your doctor advises otherwise.

Please note that the product is flammable, so keep it tightly closed and away from flames and heat sources. It's also recommended to use sunscreen while using this product and for a week afterward, as some people may become more sensitive to sunlight.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes, lips, and mouth. If you experience any irritation while using it, stop using the product and consult your doctor. It's important to keep this product out of reach of children. If it is swallowed, seek professional help or contact a Poison Control Center right away.

Be aware that this product is flammable, so keep it tightly closed and away from flames and heat sources. Additionally, if you are using a Glycolic Acid product, it's recommended to use sunscreen during treatment and for an additional week afterward, as some people may be more sensitive to sunlight.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek professional assistance or contact a Poison Control Center right away.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to seek immediate medical help. Always prioritize safety and act quickly in these situations.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. It is important to know that using this product while pregnant is contraindicated, meaning it is not recommended due to potential risks to the fetus.

If you are pregnant or planning to become pregnant, you should consult your healthcare provider before using this product. They can help you understand the risks and make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding, you can use Gly-Sal 10-2 Pads without any specific warnings or recommendations to be concerned about. The information available does not indicate any precautions or considerations that you need to take into account while nursing.

Feel confident in your choice, as there are no known risks associated with using these pads during lactation.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek professional help or contact a Poison Control Center right away. Taking quick action can help ensure their safety. Always be vigilant about where you store medications to prevent any accidental ingestion.

Geriatric Use

When it comes to using Gly-Sal 10-2 Pads, there is no specific information available about how this product should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are caring for an older adult, it’s always a good idea to consult with a healthcare professional before starting any new treatment. They can provide personalized advice and ensure that the product is safe and appropriate for their specific health needs.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your medication or treatment, it's important to discuss these with your healthcare provider for personalized advice.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to be cautious when using this product alongside other topical acne medications. Using them together or right after each other can lead to increased dryness or irritation of your skin. If you notice these side effects, it's best to use only one medication at a time unless your healthcare provider advises otherwise.

Always discuss any medications or treatments you are using with your healthcare provider to ensure they work safely and effectively for you. Your skin's health is important, and your provider can help you find the best approach.

Storage and Handling

To ensure your product remains safe and effective, store it in a cool, dry place. It is important to keep the container tightly closed to prevent any flammable materials from escaping. Always keep it away from flames and heat sources to avoid any fire hazards.

When handling the product, exercise caution due to its flammable nature. Make sure to follow these safety guidelines to protect yourself and maintain the integrity of the product.

Additional Information

You should apply this medication topically by wiping the affected area with a moist pad one to three times a day. It's important to use sunscreen while using any Glycolic Acid product and for an additional week after stopping, as some people may become more sensitive to sunlight during this time.

FAQ

What is REPLENiX® ACNE SOLUTIONS?

REPLENiX® ACNE SOLUTIONS are cleansing pads designed for the treatment of acne, featuring the skin enhancement properties of Glycolic acid.

What active ingredients are in REPLENiX® ACNE SOLUTIONS?

These pads contain 10% Glycolic Acid and 2% Salicylic Acid USP.

How should I use REPLENiX® ACNE SOLUTIONS?

Wipe the entire affected area with a moist pad one to three times daily, starting with one application daily and gradually increasing as needed.

What should I do if I experience dryness or peeling?

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Are there any contraindications for using this product?

There are no specified contraindications, but it is advised to discontinue use if irritation develops and consult a doctor.

Is REPLENiX® ACNE SOLUTIONS safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

Can I use REPLENiX® ACNE SOLUTIONS while breastfeeding?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers mentioned.

What precautions should I take while using this product?

Keep the product away from eyes, lips, and mouth, and use sunscreen as individuals may be more sensitive to sunlight when using Glycolic Acid.

What should I do if I accidentally swallow the product?

Keep out of reach of children, and if swallowed, seek professional assistance or contact a Poison Control Center immediately.

Are there any side effects associated with REPLENiX® ACNE SOLUTIONS?

Possible side effects include irritation, dryness, and increased sensitivity to sunlight. If irritation develops, discontinue use and consult a doctor.

Packaging Info

Below are the non-prescription pack sizes of Gly-Sal 10-2 Pads (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gly-Sal 10-2 Pads.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

REPLENiX® ACNE SOLUTIONS, manufactured by Topix Pharmaceuticals, Inc., is presented in the form of Gly/Sal® 10-2 Pads. Each pad contains 10% Glycolic Acid and 2% Salicylic Acid USP, formulated to address acne-related concerns. The product is packaged in a container containing 60 pads, designed for topical application.

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 drug.

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 of this product is contraindicated in patients who develop irritation during use. In such cases, discontinuation of the product is advised, and consultation with a healthcare professional is recommended. No other specific contraindications have been identified in the available data.

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. In the event that irritation develops, the product should be discontinued immediately, and a healthcare professional should be consulted for further evaluation and management.

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

The formulation is flammable; therefore, it should be stored tightly closed and kept away from flames and heat sources to minimize the risk of fire hazards.

Additionally, the use of sunscreen is strongly recommended when using any Glycolic Acid product, as some individuals may exhibit increased sensitivity to sunlight. This precaution should be maintained for at least one week following the discontinuation of the product to ensure adequate protection against potential sunburn or skin damage.

Side Effects

Patients using this product may experience a range of adverse reactions, which can be categorized based on their seriousness and frequency.

Warnings indicate that the product is for external use only and should be kept away from the eyes, lips, and mouth. In the event that irritation develops, patients are advised to discontinue use and consult a healthcare professional.

Additional adverse reactions may occur when this product is used concurrently with other topical acne medications. Such combinations may lead to increased dryness or irritation of the skin. If this occurs, it is recommended that only one medication be used unless otherwise directed by a healthcare provider.

It is important to note that the product is flammable; therefore, it should be kept tightly closed and stored away from flames and heat sources. Furthermore, the use of sunscreen is recommended while using any Glycolic Acid product and for an additional week thereafter, as some individuals may exhibit heightened 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 Pads (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gly-Sal 10-2 Pads.
Details

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 Pads 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 any adverse effects or unusual responses in this population is advisable, given the lack of established guidelines for geriatric use.

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 Pads 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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdosage, it is imperative to keep the medication out of reach of children to prevent accidental ingestion. Should ingestion occur, immediate professional assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay for further guidance.

Prompt action is crucial in managing potential overdosage situations to ensure the safety and well-being of the patient.

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 compound in these areas.

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 reach of children. In the event that the medication is swallowed, patients should seek professional assistance or contact a Poison Control Center immediately.

Additionally, healthcare providers should inform patients that if any irritation develops while using the medication, they should discontinue use and consult a doctor for further guidance.

Storage and Handling

The product is classified as flammable and must be stored in a tightly closed container. It should be kept away from sources of flame and heat to ensure safety and maintain product integrity.

Additional Clinical Information

The product is administered topically, with patients advised to wipe the entire affected area with a moist pad one to three times daily. Clinicians should counsel patients on the importance of using sunscreen while using any Glycolic Acid product and for an additional week following treatment, as some individuals may exhibit increased sensitivity to sunlight. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Gly-Sal 10-2 Pads, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.