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Replenix Acne Gly-Sal 2-2 Foaming Cleanser

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Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 19, 2019
Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2016
Label revision date
December 19, 2019
Manufacturer
Topiderm, Inc.
Registration number
M006
NDC root
51326-929

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Drug Overview

REPLENiX ACNE SOLUTIONS is a skin cleanser specifically designed to help treat acne. This foaming cleanser contains Glycolic Acid (a type of alpha hydroxy acid that helps exfoliate the skin) and Salicylic Acid (a beta hydroxy acid that penetrates pores to clear out excess oil and dead skin cells), both at a concentration of 2%.

By using this product, you can support your skin's health and work towards reducing acne breakouts. It comes in a convenient 6.7 fl. oz. (200 ml) bottle, making it easy to incorporate into your daily skincare routine.

Uses

If you're dealing with acne, this product can help you by acting as a skin cleanser specifically designed for treating this condition. It works to remove excess oil and impurities from your skin, which can contribute to breakouts. By incorporating this cleanser into your skincare routine, you may see improvements in your skin's appearance and a reduction in acne-related issues.

Dosage and Administration

To use this medication effectively, start by wetting the affected area where you plan to apply it. After that, apply the medication and rinse it off thoroughly. Initially, you should use it once a day. Depending on your needs or your doctor's advice, you can gradually increase the application to two or three times a day.

If you notice that your skin becomes too dry or irritated, it's important to reduce the frequency of application. In that case, you can cut back to using it just once a day or even every other day. Always follow your physician's guidance for the best results.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should only apply it externally and avoid contact with your eyes, lips, and mouth. If you notice increased dryness or irritation, stop using the product and consult your doctor. Additionally, if the product is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

It's also recommended to use sunscreen while using this product and for at least a week afterward, as some people may become more sensitive to sunlight. Always keep this product out of reach of children to ensure their safety.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes, lips, and mouth. If you notice increased dryness or irritation while using this product or shortly after, stop using it and consult your doctor. It's also important to keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

When using this product, consider applying sunscreen, as glycolic acid can make your skin more sensitive to sunlight. It's advisable to continue using sunscreen for at least a week after stopping the product to protect your skin.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center for guidance on what to do next. Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior.

Always take overdosing seriously. If you suspect an overdose, don’t wait—reach out for help right away. Your safety is the top priority, and medical professionals are equipped to provide the necessary assistance.

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. Because of potential risks to the fetus, it is advised that you do not use this product if you are pregnant.

If you are pregnant or planning to become pregnant, it is important to 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 or planning to breastfeed, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider about any concerns you may have regarding your health and breastfeeding.

Pediatric Use

It's important to keep this medication out of the reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center for assistance. Always be vigilant about where you store medications to ensure your child's safety.

Geriatric Use

While there is no specific information about the use of Replenix Acne Gly-Sal 2-2 Foaming Cleanser in older adults, it’s always important to approach any new product with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting this cleanser. This is especially true if you have any existing health conditions or are taking other medications, as older adults may have different skin sensitivities and needs.

Always prioritize your skin health and well-being by seeking personalized advice tailored to your unique situation.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.

Drug Interactions

It's important to be cautious when using this product alongside other topical medications. Doing so may lead to increased dryness or irritation of your skin. If you notice these symptoms, it's best to stop using the product and consult your healthcare provider for guidance.

Always discuss any medications or treatments you are using with your doctor. They can help you understand potential interactions and ensure that your skincare routine is safe and effective.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when you're not using it to prevent contamination. Once you open the container, be sure to discard it after use to maintain safety and effectiveness. Following these simple steps will help you use the product safely and effectively.

Additional Information

You will apply this medication topically, which means you will apply it directly to your skin. It's important to use sunscreen while using any products containing glycolic acid, as they can make your skin more sensitive to sunlight. You should continue using sunscreen for an additional week after stopping the glycolic acid product to protect your skin.

FAQ

What is REPLENiX ACNE SOLUTIONS?

REPLENiX ACNE SOLUTIONS is a skin cleanser designed for the treatment of acne.

What active ingredients are in REPLENiX ACNE SOLUTIONS?

It contains 2% Glycolic Acid and 2% Salicylic Acid USP.

How should I use REPLENiX ACNE SOLUTIONS?

Wet the affected area, apply the cleanser, and rinse well. Start with one application daily, then gradually increase to two or three times daily if needed.

What should I do if I experience dryness while using this product?

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

Are there any warnings associated with REPLENiX ACNE SOLUTIONS?

Yes, it is for external use only. Keep it away from your eyes, lips, and mouth, and discontinue use if you experience increased dryness or irritation.

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.

What precautions should I take if I am pregnant or planning to become pregnant?

Consult a healthcare provider before using this product if you are pregnant or planning to become pregnant.

What should I do if REPLENiX ACNE SOLUTIONS is swallowed?

Keep it out of the reach of children. If swallowed, get medical help or contact a Poison Control Center.

How should I store REPLENiX ACNE SOLUTIONS?

Store at room temperature, protect from light, and keep the container tightly closed when not in use.

Is sunscreen recommended while using this product?

Yes, sunscreen use is recommended with any glycolic acid product and for an additional week thereafter due to increased sensitivity to sunlight.

Packaging Info

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

Packaging configurations for Replenix Acne Gly-Sal 2-2 Foaming Cleanser.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

REPLENiX® ACNE SOLUTIONS Gly/Sal® 2-2 is a foaming cleanser formulated to address acne. It contains Glycolic Acid at a concentration of 2% and Salicylic Acid USP at 2%. The product is packaged in a net volume of 6.7 fluid ounces (200 ml). 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. It is designed to help reduce the severity and frequency of acne lesions in affected individuals.

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 begin 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

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes, lips, and mouth. The concurrent use of other topical medications while using this product, or immediately thereafter, may exacerbate dryness or irritation. Should such reactions occur, it is advised to discontinue use and consult a healthcare professional.

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 should be made with a Poison Control Center.

The use of sunscreen is strongly recommended when utilizing any glycolic acid product, as well as for an additional week following its use. This precaution is particularly important as certain individuals may exhibit heightened sensitivity to sunlight.

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes, lips, and mouth. The concurrent use of other topical medications may lead to increased dryness or irritation; should this occur, patients are advised to discontinue use and consult their healthcare provider.

In terms of safety, 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 should be made with a Poison Control Center.

Additionally, participants using this product, particularly those with glycolic acid, are advised to use sunscreen. This recommendation extends for an additional week following the use of the product, as some individuals may exhibit heightened sensitivity to sunlight.

Drug Interactions

The concurrent use of other topical medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advised to discontinue the use of this product and consult a healthcare professional for further evaluation and guidance. Monitoring for signs of skin irritation is recommended when using this product alongside other topical agents.

Packaging & NDC

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

Packaging configurations for Replenix Acne Gly-Sal 2-2 Foaming Cleanser.
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 medical assistance or contact a Poison Control Center immediately.

Geriatric Use

There is no specific information regarding the use of Replenix Acne Gly-Sal 2-2 Foaming Cleanser in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions that may be necessary for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment outcomes in this population.

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 this medication in nursing mothers. Additionally, there are no specific warnings or recommendations concerning lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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, immediate medical assistance is essential. Healthcare professionals are advised to seek medical help or contact a Poison Control Center 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 crucial. Prompt recognition of symptoms can facilitate timely intervention and management.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise from the overdosage.

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, particularly in households with children.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The container should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients to use sunscreen when 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 Replenix Acne Gly-Sal 2-2 Foaming Cleanser, 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 Replenix Acne Gly-Sal 2-2 Foaming Cleanser, 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.

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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.