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Dermaclear Mask

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Active ingredient
Salicylic Acid 20 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
December 4, 2024
Active ingredient
Salicylic Acid 20 mg/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2015
Label revision date
December 4, 2024
Manufacturer
Allure Labs Inc,
Registration number
M006
NDC root
62742-4074

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

This medication is designed for the treatment of acne, helping to improve the appearance of your skin. It is manufactured by DermaQuest®, Inc., based in Hayward, California, and is made in the USA. If you're looking for a solution to manage acne, this product may be worth considering as part of your skincare routine. For more information, you can visit their website at dermaquestinc.com.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating, but with the right treatment, you can see improvements in your skin's appearance and health.

It's important to note that this medication does not have any known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential side effects related to pregnancy or other conditions. Always consult with your healthcare provider to determine if this treatment is right for you.

Dosage and Administration

To use this product effectively, start by applying a thin layer to the affected areas of your skin after you’ve cleansed the area. You can use your fingertips for this application. Once applied, gently massage the product into your skin using circular movements for about 1 to 2 minutes.

After massaging, let the product sit on your skin for 5 to 10 minutes. The exact time will depend on how your skin reacts to it, so pay attention to your skin's tolerance and sensitivity. Once the time is up, rinse your skin thoroughly and follow any recommended post-mask care instructions to ensure the best results.

What to Avoid

You should avoid using this product if you have very sensitive skin, as it may cause irritation or adverse reactions. It's important to prioritize your skin's health and well-being, so please consult with a healthcare professional if you're unsure about your skin type or have any concerns before using this product.

Side Effects

It's important to know that this medication is for external use only. You should stop using it and consult your doctor if you experience severe skin irritation. Additionally, if you are using other topical medications at the same time, it's advisable to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help or contact a Poison Control Center immediately.

If you have very sensitive skin, it's best not to use this product. You should also stop using it and consult your doctor if you experience severe skin irritation or if you are using other topical medications at the same time. Your safety is important, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include extreme drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your safety and health.

Pregnancy Use

When it comes to using DERMACLEAR MASK (salicylic acid cream) during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that the effects of this product on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby when considering any treatments.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications 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 medical help immediately or contact a Poison Control Center for guidance. Always be vigilant about where you store medications to ensure your child's safety.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to be cautious when using this product alongside other topical acne medications. Using multiple acne treatments at the same time or right after each other can lead to increased dryness or irritation of your skin. If you notice any discomfort, it's best to stick to one medication unless your healthcare provider advises otherwise.

Additionally, combining this product with other topical medications can result in severe skin irritation. Always discuss any medications or treatments you are using with your healthcare provider to ensure your skin stays healthy and to avoid any unwanted side effects.

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 not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines 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 the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication. If you have any specific questions or concerns, be sure to discuss them with your healthcare provider.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How should I apply this product?

Apply a thin layer to affected areas after cleansing, massage gently for 1-2 minutes, and allow it to remain on the skin for 5-10 minutes.

What should I do if I experience severe skin irritation?

Stop use and ask a doctor if severe skin irritation occurs.

Can I use other topical acne medications at the same time?

Using other topical acne medications may increase dryness or irritation; only one should be used unless directed by a doctor.

Are there any contraindications for this product?

Do not use this product if you have very sensitive skin.

What precautions should I take regarding sun exposure?

If sensitive to the sun or increased sun exposure is expected, use a sunscreen.

Is this product safe to use during pregnancy?

There is no specific information provided regarding the use of this product during pregnancy.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison control center right away.

How should I store this product?

Store at room temperature, protect from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Dermaclear Mask (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermaclear Mask.
Details

Drug Information (PDF)

This file contains official product information for Dermaclear Mask, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Manufactured for DermaQuest®, Inc., located in Hayward, California, this product is produced in the USA. The company’s website is dermaquestinc.com.

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this medication.

Dosage and Administration

Healthcare professionals are advised to apply a thin layer of the product to the affected areas after cleansing the skin with fingertips. The application should be followed by gentle massage in circular movements for a duration of 1 to 2 minutes. It is important to allow the product to remain on the skin for 5 to 10 minutes, adjusting the time based on the patient's skin tolerance and sensitivity.

After the designated time, the product should be rinsed off thoroughly. Following the rinse, it is recommended to adhere to the suggested post-mask home care regimen to optimize treatment outcomes.

Contraindications

Use is contraindicated in patients with very sensitive skin due to the potential for adverse reactions.

Warnings and Precautions

For external use only. This product is not intended for internal use, and ingestion may lead to serious health consequences. In the event of accidental swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Caution is advised for individuals with very sensitive skin. The use of this product in such cases may lead to adverse reactions. Healthcare professionals should assess the patient's skin sensitivity prior to recommending this product.

Patients should be instructed to discontinue use and consult a physician if severe skin irritation develops. Additionally, concurrent use with other topical medications should be avoided unless directed by a healthcare provider, as this may increase the risk of skin irritation or other adverse effects.

Side Effects

Patients should be advised that the product is for external use only. In the event of severe skin irritation, it is recommended to discontinue use and consult a healthcare professional. Additionally, caution should be exercised when using this product concurrently with other topical medications, as this may exacerbate skin irritation or lead to other adverse reactions.

Drug Interactions

Concurrent use of other topical acne medications or topical treatments 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.

Additionally, the simultaneous application of other topical medications may result in severe skin irritation. Therefore, careful consideration should be given to the use of multiple topical agents, and monitoring for signs of irritation is recommended.

Packaging & NDC

Below are the non-prescription pack sizes of Dermaclear Mask (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Dermaclear Mask.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no information available regarding the use of DERMACLEAR MASK (salicylic acid cream) during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits before prescribing this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may also be beneficial in managing the situation effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for guiding treatment decisions and ensuring patient safety.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

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

Patient Counseling

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

Patients should be informed not to use this product if they have very sensitive skin, as it may exacerbate their condition. When using this product, it is crucial to avoid contact with the eyes, lips, and mouth to prevent irritation.

Additionally, healthcare providers should counsel patients on the potential for increased dryness or irritation of the skin when using this product in conjunction with other topical acne medications. If such reactions occur, patients should be instructed to use only one medication unless otherwise directed by a healthcare professional.

Finally, patients should be made aware of the importance of sun protection. If they are sensitive to the sun or anticipate increased sun exposure, they should use a sunscreen to mitigate the risk of adverse effects.

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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Dermaclear Mask, 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 Dermaclear Mask, 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.