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Byoma Acne Control Body

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Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
April 23, 2025
Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
April 23, 2025
Manufacturer
Byoma Ltd
Registration number
M006
NDC root
84821-004

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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, helping to reduce breakouts and improve the overall appearance of your skin.

By targeting the factors that contribute to acne, this treatment can assist in clearing your skin and preventing future blemishes. If you're struggling with acne, this medication may be a helpful option to consider in your skincare routine.

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 known 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 looking for a solution to manage your acne, this treatment could be a beneficial choice for you.

Dosage and Administration

Before using this product, make sure to clean the affected area of your skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire affected area. You can do this one to three times a day, depending on your needs and your doctor's advice.

To avoid excessive drying of your skin, it’s best to start with just one application each day. If your skin tolerates it well, you can gradually increase to two or three applications daily. However, if you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day. This way, you can find the right balance for your skin while still getting the benefits of the treatment.

What to Avoid

It's important to be mindful of how you use this medication. If you experience any skin irritation or if it worsens, you should stop using the product and consult your doctor. Additionally, using this medication alongside another topical acne treatment can increase the risk of skin irritation and dryness. To minimize these risks, it's best to use only one topical acne medication at a time.

Side Effects

When using this product, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time. If you notice any skin irritation that worsens, stop using the product and consult your doctor.

This product is for external use only. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Centre immediately.

Warnings and Precautions

This medication is for external use only. If you are using other topical acne treatments, be cautious, as combining them can increase the chances of skin irritation and dryness. To minimize this risk, it’s best to use only one topical acne medication at a time.

If you experience skin irritation or if it worsens, stop using the product and consult your doctor. Additionally, if the medication is accidentally swallowed, seek medical help immediately or contact a Poison Control Centre. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help or contact a Poison Control Centre immediately. Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior.

Don't wait to see if symptoms develop; getting prompt assistance can be crucial. Always keep emergency contact numbers handy and be aware of the steps to take in case of an overdose. Your safety and well-being are the top priority.

Pregnancy Use

It’s important to be cautious when considering the use of this product during pregnancy, as its safety has not been established. High doses or prolonged use of salicylic acid, a common ingredient in some medications, is not recommended during pregnancy due to potential risks to your developing baby.

If you are pregnant or planning to become pregnant, it’s essential to consult with your healthcare provider before using this product. They can help you understand the risks and determine the best course of action for your health and the health of your baby.

Lactation Use

If you are breastfeeding, 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 if you have any concerns or questions about your specific situation.

Pediatric Use

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

Geriatric Use

While there is no specific information about the use of Byoma Acne Control Body Lotion in older adults, it’s always wise to approach any new treatment 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 product. This is especially important if you have any underlying health conditions or are taking other medications, as these factors can influence how your body responds to new treatments. Always prioritize your health and safety by seeking personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that the provided drug insert does not include any specific information regarding dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no additional guidelines or recommendations for how this medication should be used if you have renal impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take 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 there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have 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 multiple acne treatments. If you use 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 best performance 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. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling 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 apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily.

What should I do if my skin becomes dry or irritated?

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

Can I use this product with other topical acne medications?

Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

What should I do if I experience skin irritation?

Stop use and ask a doctor if skin irritation occurs or gets worse.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and high doses of salicylic acid are contraindicated due to potential risks to the fetus.

What precautions should I take if I am pregnant?

Consult a healthcare provider before use if you are pregnant or planning to become pregnant.

What should I do if this product is swallowed?

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

How should I store this product?

Protect the product from excessive heat and direct sunlight.

Is there any information regarding use in elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

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

Packaging configurations for Byoma Acne Control Body.
Details

Drug Information (PDF)

This file contains official product information for Byoma Acne Control Body, 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 or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This can be done one to three times daily, depending on the patient's needs and the physician's guidance.

To minimize the risk of excessive drying of the skin, it is advisable to initiate treatment with one application per day. Based on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily as necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once a day or every other day to alleviate these symptoms.

Contraindications

Use is contraindicated in patients who experience skin irritation or worsening of skin conditions upon application. If skin irritation occurs, discontinue use and consult a healthcare professional. Concurrent use with other topical acne medications is not recommended, as this may increase the likelihood of skin irritation and dryness; therefore, only one topical acne medication should be used at a time.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the application of this product may lead to skin irritation and dryness, particularly if used concurrently with other topical acne medications. To minimize the risk of irritation, it is recommended that patients use only one topical acne medication at a time.

In the event that skin irritation occurs or worsens, patients should be instructed to discontinue use immediately and consult a healthcare provider for further evaluation and guidance.

In cases of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Centre without delay. Prompt action is essential to ensure patient safety and appropriate management of any potential adverse effects.

Side Effects

Patients using this product should be aware that it is for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. If patients experience skin irritation, it is advised to discontinue use and consult a healthcare professional, especially if the irritation worsens.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is recommended. It is crucial to keep this product out of reach of children to prevent any potential harm.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of additional topical agents is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

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

Packaging configurations for Byoma Acne Control Body.
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 Control Body Lotion in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are applicable to elderly patients. Therefore, healthcare providers should exercise clinical judgment when considering the use of this product in the geriatric population, as individual patient factors may influence treatment decisions. Monitoring for efficacy and potential adverse effects is recommended, as with any treatment in elderly patients.

Pregnancy

The safety of this product during pregnancy has not been established. The use of salicylic acid in high doses or for prolonged periods is contraindicated in pregnancy due to potential risk to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 this medication 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 caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

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 procedures.

Healthcare providers should ensure that patients are monitored closely for any signs of toxicity and that supportive care is initiated as necessary.

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 in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Centre if the product is swallowed. It is important for healthcare providers to emphasize the seriousness of this action and the need for prompt intervention.

Patients should also be instructed to discontinue use and consult a doctor if they experience skin irritation or if the irritation worsens. Healthcare providers should discuss the potential for skin irritation and dryness, particularly in the context of concurrent use with other topical acne medications. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

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 Control Body, 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 Control Body, 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.