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Mdacne Customized Acne Treatment Salicylic Acid

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Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
September 19, 2024
Active ingredient
Salicylic Acid 20 mg/1 mL
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 2024
Label revision date
September 19, 2024
Manufacturer
MDAlgorithms Inc
Registration number
M006
NDC root
71804-533

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Drug Overview

This medication is used for the treatment of acne, helping to clear up acne pimples and blemishes while allowing your skin to heal. It also works to prevent new pimples and blemishes from forming, promoting healthier skin overall. If you're struggling with acne, this treatment may be a supportive option to consider for improving your skin's appearance.

Uses

If you're dealing with acne, this treatment can help you clear up pimples and blemishes, allowing your skin to heal effectively. Not only does it work to eliminate existing acne, but it also helps prevent new pimples and blemishes from forming, giving you a better chance at maintaining clear skin.

You can feel confident using this treatment, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with it. This makes it a safe option for those looking to improve their skin health.

Dosage and Administration

Before you apply the medication, make sure to cleanse the skin thoroughly. This helps ensure that the medication can work effectively. Once your skin is clean, apply an even layer of the medication directly over the affected area.

It's important to avoid using the medication on broken skin or on large areas of your body, as this can lead to unwanted side effects. For optimal results, you should apply the medication one to three times a day, depending on your specific needs.

What to Avoid

It's important to be mindful of how you use this medication. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should avoid using it for extended periods without first consulting your doctor. This ensures that you are using the medication safely and effectively. Always prioritize your health by seeking professional guidance when needed.

Side Effects

When using this product, it's important to remember that it is for external use only. If you are using other topical acne treatments at the same time, you may experience increased dryness or irritation of your skin. To minimize these effects, start by applying the product once a day. You can gradually increase to twice a day if necessary, but if you notice bothersome dryness or peeling, reduce your application to once daily.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended for treatment. If you are using other topical acne medications, be cautious, as combining them may lead to increased dryness or irritation of your skin. To minimize the risk of excessive drying, start by using this product once a day. You can gradually increase to twice daily if needed, but if you experience bothersome dryness or peeling, reduce your use back to once a day.

It's important not to use this product for extended periods without consulting your doctor. Always keep it out of reach of children. If the product is swallowed, seek immediate help from a physician or contact a poison control center.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Contact your physician or a poison control center immediately for guidance. They can provide you with the necessary steps to take based on the specific situation.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

The safety of salicylic acid during pregnancy has not been established, and it is generally advised against its use. This is because there are potential risks to the developing fetus. If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using any products containing salicylic acid. They can help you weigh the potential benefits against the risks to ensure the best outcome for you and your baby.

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 your child accidentally swallows it, you should contact a physician or poison control center right away for guidance.

When using this medication on children, start with one application per day to avoid excessive drying of the skin. You can gradually increase to two times a day if necessary, but only if directed by a doctor. If you notice any bothersome dryness or peeling, reduce the application back to once a day. Additionally, avoid using it for long periods without consulting a doctor to ensure your child's safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

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 kidney function might affect the use of this medication.

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

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 how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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. To ensure your skincare routine is safe and effective, always discuss any medications or treatments you are using with your healthcare provider. They can help you find the best approach for your skin without causing unnecessary discomfort.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place where the temperature remains below 20ºC (70ºF). This helps maintain its effectiveness and integrity.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a sterile field (a clean area free from germs) if applicable, and dispose of any used components according to local regulations to ensure safety and environmental protection.

Additional Information

You should apply this medication topically, which means you will put it directly on your skin. For the best results, use it one to three times a day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is this medication used for?

This medication is used for the treatment of acne. It helps clear up acne pimples and blemishes, allowing the skin to heal and preventing new pimples from forming.

How should I apply this medication?

You should cleanse the skin thoroughly before applying an even layer over the affected area. For best results, apply one to three times per day.

Are there any warnings I should be aware of?

This medication is for external use only. Using other topical acne medications at the same time may increase dryness or irritation of the skin.

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

If you experience bothersome dryness or peeling, reduce application to once per day. Start with one use daily and gradually increase to two times daily if needed.

Is this medication safe to use during pregnancy?

The safety of this medication during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider before use.

What should I do if this medication is swallowed?

If swallowed, contact a physician or poison control center immediately.

Where should I store this medication?

Store this medication in a cool, dry place below 20ºC (70ºF).

Are there any contraindications for using this medication?

There are no specific contraindications listed, but do not use for prolonged periods without consulting a doctor.

Packaging Info

Below are the non-prescription pack sizes of Mdacne Customized Acne Treatment Salicylic Acid (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mdacne Customized Acne Treatment Salicylic Acid.
Details

Drug Information (PDF)

This file contains official product information for Mdacne Customized Acne Treatment Salicylic Acid, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively clears up acne pimples and blemishes, facilitating the healing of the skin. Additionally, it aids in the prevention of new pimples and blemishes from forming.

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

Dosage and Administration

Healthcare professionals are advised to cleanse the skin thoroughly prior to the application of the medication. An even layer should be applied directly to the affected area. It is important to note that the medication should not be used on broken skin or on large areas of the body.

For optimal results, the medication may be applied one to three times per day, depending on the severity of the condition and the clinical judgment of the healthcare provider.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that the product should not be used for prolonged periods without consulting a healthcare professional. This recommendation is made to ensure appropriate monitoring and management of potential risks associated with extended use.

Warnings and Precautions

For external use only. The concurrent use of other topical acne medications may exacerbate skin dryness or irritation. To mitigate the risk of excessive drying, it is recommended to initiate treatment with a single daily application, gradually increasing to twice daily as necessary or as directed by a healthcare professional. Should significant dryness or peeling occur, the frequency of application should be reduced to once daily.

Prolonged use of this product without medical consultation is not advised. It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate contact with a physician or poison control center is imperative.

Side Effects

Patients using this product should be aware that it is intended for external use only. The concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin. To mitigate the risk of excessive drying, it is recommended that patients begin with a single application daily. If tolerated, the frequency may be gradually increased to twice daily, as directed by a healthcare professional. Should patients experience bothersome dryness or peeling, they are advised to reduce the application frequency to once per day.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to an increased risk of skin dryness or irritation. It is advisable to monitor the skin condition closely when these products are used together. If excessive dryness or irritation occurs, consideration should be given to adjusting the frequency of application or discontinuing one of the treatments to mitigate these effects.

Packaging & NDC

Below are the non-prescription pack sizes of Mdacne Customized Acne Treatment Salicylic Acid (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mdacne Customized Acne Treatment Salicylic Acid.
Details

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate contact with a physician or poison control center is advised.

For topical application, it is recommended to initiate treatment with one use daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two times daily if necessary or as directed by a healthcare professional. Should any bothersome dryness or peeling occur, the application frequency should be reduced to once daily.

Prolonged use of this medication in pediatric patients should only occur under the guidance of a healthcare provider.

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

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus. Therefore, use during pregnancy should be avoided unless the potential benefits outweigh the risks. Healthcare providers should be consulted prior to use to assess individual circumstances and determine the appropriateness of treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided regarding the potential for excretion in breast milk or any associated risk 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 event of an overdosage, it is imperative to seek immediate medical attention. If the substance is ingested, the healthcare professional should contact a physician or a poison control center without delay.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare providers are advised to monitor the patient closely for any symptoms that may arise as a result of the overdose.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical scenario presented by the patient. It is essential to follow established protocols for the management of overdose cases to ensure optimal patient 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 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 to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to contact their physician or a poison control center immediately for guidance.

Additionally, it is important for healthcare providers to inform patients that the medication should not be used for prolonged periods without consulting a doctor. This precaution helps to ensure the safe and effective use of the medication while minimizing potential risks associated with extended use.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored in a cool, dry place, maintaining a temperature below 20ºC (70ºF) to ensure optimal stability and efficacy. Proper storage conditions are essential to preserve the integrity of the product.

Additional Clinical Information

The product is administered topically, with optimal results achieved when applied one to three times per day. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mdacne Customized Acne Treatment Salicylic Acid, 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 Mdacne Customized Acne Treatment Salicylic Acid, 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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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.