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Byoma Acne Clearing 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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
April 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
April 23, 2025
Manufacturer
Byoma Ltd
Registration number
M006
NDC root
84821-007
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

Acne is a common skin condition that can affect people of all ages, and there are various treatments available to help manage it. This medication is specifically designed for the treatment of acne, aiming to reduce breakouts and improve the overall appearance of your skin.

If you're struggling with acne, this treatment may be a helpful option to consider as part of your skincare routine. Always consult with a healthcare professional to determine the best approach for your individual needs.

Uses

If you're dealing with acne, this medication is specifically designed to help treat this common skin condition. Acne can be frustrating and affect your confidence, but this treatment aims to reduce breakouts and improve the overall appearance of your skin.

It's important to note that there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for many individuals. If you're considering this treatment, it could be a step towards clearer skin.

Dosage and Administration

To use this medication effectively, start by wetting your skin. Then, gently massage the product onto your skin for about 1 to 2 minutes before rinsing it off thoroughly. This process helps ensure that the medication is properly absorbed and can work effectively.

If you notice any bothersome dryness or peeling of your skin after using the product, it’s important to reduce how often you apply it. This adjustment can help prevent irritation while still allowing you to benefit from the treatment.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if you experience severe irritation. Your health and safety are paramount, so always communicate any adverse effects you encounter.

Side Effects

This product is for external use only. You may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. If you notice irritation, it’s best to stop using one of the products. If the irritation becomes severe, please stop using the product and consult a doctor.

Be cautious to keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Centre immediately. Additionally, if the product accidentally gets into your eyes, rinse them with water right away.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas other than your skin. If you are using another topical acne medication, be cautious, as this can increase the chances of skin irritation and dryness. If you experience irritation, it’s best to stop using both products and only use one at a time. If the product accidentally gets into your eyes, rinse them immediately with water.

You should stop using this product and call your doctor if you notice that the irritation becomes severe. Additionally, if the product is swallowed, seek emergency medical help or contact a Poison Control Centre right away. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Centre or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

There is currently no specific information available about the use of Byoma Acne Clearing Cleanser during pregnancy. This means that the drug insert does not provide details on safety concerns, dosage adjustments, or any special precautions you should take if you are pregnant or planning to become pregnant.

If you are considering using this product while pregnant, it is important to consult with your healthcare provider to discuss any potential risks and to ensure that you are making the best choice for your health and your baby's health.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Centre for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When using Byoma Acne Clearing Cleanser, there is no specific information available about its use in older adults. This means that there are no recommended dosage adjustments, safety concerns, or special 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 skincare product, especially if there are existing health conditions or concerns.

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 standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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 or precautions outlined for patients with liver impairment.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to be cautious when using multiple acne treatments at once. If you apply another topical acne medication alongside this one, you may experience increased skin irritation and dryness. To minimize these side effects, it's best to use only one topical acne medication at a time.

Always discuss your current medications and any new treatments with your healthcare provider. They can help you understand the best approach for your skin care routine and ensure that you avoid any unnecessary discomfort.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep the product in its container and protect it from excessive heat and direct sunlight, as these conditions can damage it.

When handling the product, always do so with care to maintain its integrity. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How should I use this product?

Wet your skin, gently massage the product for 1-2 minutes, and then rinse well.

What should I do if I experience dryness or peeling?

If bothersome dryness or peeling occurs, reduce the frequency of use.

Are there any warnings I should be aware of?

This product is for external use only. Rinse immediately with water if it gets in your eyes.

What should I do if irritation becomes severe?

Stop use and ask a doctor if irritation becomes severe.

Is there any risk if the product is swallowed?

If swallowed, get medical help or contact a Poison Control Centre right away.

Can I use this product with other topical acne medications?

Skin irritation and dryness are more likely if you use another topical acne medication at the same time. Only use one at a time if irritation occurs.

Is this product safe for children?

Keep this product out of reach of children.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing mothers.

What should I do to protect the product?

Protect the product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Byoma Acne Clearing Cleanser.
Details

Drug Information (PDF)

This file contains official product information for Byoma Acne Clearing Cleanser, 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. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should instruct patients to wet the skin prior to application. The product should be gently massaged onto the skin for a duration of 1 to 2 minutes, followed by thorough rinsing with water.

In cases where patients experience bothersome dryness or peeling, it is recommended to reduce the frequency of use to mitigate these effects.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if irritation becomes severe.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes; if the product inadvertently enters the eyes, it should be rinsed immediately with water to prevent irritation.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. Therefore, it is recommended that only one topical acne treatment be utilized at a time to minimize the risk of adverse effects.

Patients should be instructed to discontinue use and consult a healthcare provider if they experience severe irritation.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Centre without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Common adverse reactions include skin irritation and dryness, which are more likely to occur if another topical acne medication is used concurrently. In the event of irritation, it is advised to limit the use to one topical acne medication at a time.

If the product comes into contact with the eyes, it should be rinsed immediately with water. Patients are advised to stop using the product and consult a healthcare professional if irritation becomes severe.

Additionally, this product should be kept out of reach of children. In cases of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Centre without delay.

Drug Interactions

Concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the use of topical acne treatments to one at a time to minimize the potential for adverse effects. If irritation occurs, the patient should discontinue the use of additional topical acne medications and consult a healthcare professional for further guidance.

Packaging & NDC

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

Packaging configurations for Byoma Acne Clearing Cleanser.
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 contact with a Poison Control Centre is recommended.

Geriatric Use

There is no specific information regarding the use of Byoma Acne Clearing Cleanser in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when recommending this product to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential sensitivities. Monitoring for any adverse effects is advisable when this product is used in the geriatric population.

Pregnancy

There is no specific information regarding the use of Byoma Acne Clearing Cleanser during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when advising pregnant patients or women of childbearing potential. It is recommended that the potential risks and benefits be carefully weighed before use in this population.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 are no established 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, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Centre without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. It is important for patients to understand the potential for skin irritation and dryness, particularly if they are using another topical acne medication concurrently. Providers should emphasize that if irritation becomes severe, patients should discontinue use and consult a doctor.

Additionally, patients should be instructed to rinse their eyes immediately with water if the product comes into contact with them. This guidance is crucial to ensure patient safety and to minimize the risk of adverse effects associated with the use of this medication.

Storage and Handling

The product is supplied in a container designed to safeguard its integrity. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Byoma Acne Clearing 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 Byoma Acne Clearing 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.

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.