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Gly-Sal 5-2 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1990
Label revision date
October 22, 2019
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 1990
Label revision date
October 22, 2019
Manufacturer
Topiderm, Inc.
Registration number
M006
NDC root
51326-038
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

REPLENiX is a product designed to help treat acne while also enhancing your skin. It comes in the form of cleansing pads that contain two active ingredients: Glycolic acid (5%), which helps exfoliate and improve skin texture, and Salicylic acid (2%), which is known for its ability to penetrate pores and reduce acne.

These pads are manufactured by Topix Pharmaceuticals and are packaged in a convenient set of 60 pads, making it easy for you to incorporate them into your skincare routine.

Uses

If you're looking for a solution to help manage acne, these cleansing pads could be a great option for you. They contain Glycolic acid, which is known for its skin enhancement properties, helping to improve the overall appearance of your skin while treating acne.

It's important to note that there are no teratogenic effects (which means they do not cause birth defects) associated with these pads, making them a safer choice for many users. Additionally, there are no nonteratogenic effects mentioned, ensuring that you can use them with confidence.

Dosage and Administration

To use this medication effectively, start by wiping the entire affected area with a moist pad once a day. This initial application helps you gauge how your skin responds. If you find that your skin tolerates it well, you can gradually increase the frequency to two or three times a day, but only if needed or as your doctor advises.

It's important to pay attention to how your skin reacts. If you experience bothersome dryness or peeling, reduce the application frequency to once a day or even every other day. This way, you can still benefit from the treatment while minimizing any discomfort. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to be aware of certain guidelines when using this medication. 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 noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and safety by following the instructions provided and seeking medical guidance when needed.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes, lips, and mouth. If you experience any skin irritation while using it, stop using the product and consult your doctor. Additionally, using this product alongside other topical acne treatments may lead to increased dryness or irritation. If this happens, it's best to use only one medication at a time unless your doctor advises otherwise.

Always keep this product out of reach of children. If it is accidentally swallowed, seek professional help or contact a Poison Control Center right away.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes, lips, or mouth. If you experience any irritation while using it, stop using the product right away and consult your doctor for advice.

Make sure to keep this product out of reach of children. If a child accidentally swallows it, seek professional help or contact a Poison Control Center immediately for assistance. Your safety is important, so please follow these precautions carefully.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. Seek professional assistance or contact a Poison Control Center right away. They can provide guidance on what to do next and help ensure safety.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms. If you notice anything concerning, don’t hesitate to reach out for help. Remember, getting prompt assistance can make a significant difference in managing the situation effectively.

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 note that using this product while pregnant is contraindicated, as there are potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using this product. They can provide guidance and help you understand any risks involved. Your health and the health of your baby are the top priority, so always seek professional advice when considering any medication or treatment during pregnancy.

Lactation Use

If you are breastfeeding, you can use Gly-Sal 5-2 Pads without any specific warnings or recommendations to be concerned about. The information available does not indicate any particular precautions or considerations for nursing mothers.

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

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 right away or contact a Poison Control Center for immediate assistance. Always prioritize safety and be vigilant about where medications are stored.

Geriatric Use

When it comes to using Gly-Sal 5-2 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

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the medication may not have special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment you receive is safe and appropriate for your kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 igniting. 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 entire affected area with a moist pad one to three times daily. It's important to use sunscreen while using any Glycolic Acid product, as it can make your skin more sensitive to sunlight. Continue using sunscreen for an additional week after stopping the product to protect your skin.

FAQ

What is REPLENiX?

REPLENiX is a product consisting of cleansing pads designed for the treatment of acne, featuring the skin enhancement properties of Glycolic acid.

What active ingredients are in REPLENiX?

REPLENiX contains 5% Glycolic Acid and 2% Salicylic Acid USP.

How should I use REPLENiX cleansing pads?

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

What should I do if I experience irritation while using REPLENiX?

If irritation develops, discontinue use and consult a doctor.

Is REPLENiX safe to use during pregnancy?

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

Can I use other topical acne medications with REPLENiX?

Using other topical acne medications at the same time may increase dryness or irritation. It's best to use only one medication unless directed by a doctor.

What precautions should I take when using REPLENiX?

For external use only; keep away from eyes, lips, and mouth. Also, keep out of reach of children and seek professional help if swallowed.

Are there any specific warnings for nursing mothers regarding REPLENiX?

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

What should I do if I experience bothersome dryness or peeling?

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

How should I store REPLENiX?

Keep REPLENiX tightly closed and away from flame and heat, as it is flammable.

Packaging Info

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

Packaging configurations for Gly-Sal 5-2 Pads.
Details

Drug Information (PDF)

This file contains official product information for Gly-Sal 5-2 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® 5-2 Pads. Each pad contains 5% 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. The formulation is designed to improve skin condition while effectively addressing acne-related concerns.

There are no teratogenic or nonteratogenic effects associated with this drug, indicating a favorable safety profile in these contexts.

Dosage and Administration

Healthcare professionals are advised to administer the treatment by wiping the entire affected area with a moist pad. The initial application should be once daily, with the possibility of increasing the frequency to two or three times daily based on the patient's response or as directed by a physician.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once daily or every other day to mitigate these effects. Regular monitoring of the patient's skin condition is essential to ensure optimal dosing and to adjust the regimen as necessary.

Contraindications

Use is contraindicated in patients who develop irritation during treatment. In such cases, discontinuation of use and consultation with a healthcare professional is advised. No other specific contraindications have been identified.

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 during use, the application should be discontinued immediately, and a healthcare professional should be consulted for further evaluation and guidance.

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 to ensure appropriate management and care.

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, if irritation develops, it is advised to discontinue use and consult a healthcare professional.

Additionally, concurrent use of other topical acne medications may exacerbate dryness or irritation of the skin. In such cases, it is recommended that only one medication be used unless otherwise directed by a physician.

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

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 5-2 Pads (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gly-Sal 5-2 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 5-2 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 is advisable in this population, given the general considerations for increased sensitivity to medications 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 patients or women of childbearing potential should consult a healthcare provider before use if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of Gly-Sal 5-2 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient circumstances when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.

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; therefore, a thorough assessment is essential. Prompt recognition of symptoms can facilitate timely intervention and management.

Management of overdosage should be conducted in a clinical setting, where healthcare providers can monitor the patient closely and implement appropriate treatment protocols. This may include supportive care and symptomatic treatment as necessary, tailored to the specific circumstances of the overdosage incident.

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 fully evaluate the nonclinical toxicology profile.

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 of accidental ingestion, patients should seek professional assistance or contact a Poison Control Center immediately.

Additionally, patients should be informed that if they experience any irritation while using the product, 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 5-2 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 5-2 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

Last AI update:

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.