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Byoma Acne Control Moisturizer

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Active ingredient
Salicylic Acid 15 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 15 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
84821-006

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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, 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 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 the frequency to two or three times daily. However, if you notice any bothersome dryness or peeling, reduce the 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 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 any skin irritation or if the irritation worsens. Your health and safety are paramount, so don't hesitate to seek medical advice if you have any concerns.

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 or if it worsens, you should stop using the product and consult your doctor for further advice. Remember, this product is for external use only.

Warnings and Precautions

This medication is intended for external use only. If you are using another topical acne treatment at the same time, be aware that this can increase the chances of skin irritation and dryness. To minimize these risks, it’s best to use only one topical acne medication at a time.

If you experience any 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 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 require prompt attention. Always err on the side of caution and get help if you suspect an overdose has occurred. Your health and safety are the top priority.

Pregnancy Use

When it comes to using Byoma Acne Control Moisturizer during pregnancy, there is currently no specific information available about its safety or any necessary precautions. This means that the insert does not address whether it is safe to use during this time, how the dosage might need to change, or if there are any special considerations you should be aware of.

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 understand any potential risks and guide you on the best skincare options for your situation.

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 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 Moisturizer in older adults, it’s always wise to approach new products with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consider consulting with a healthcare professional before starting this moisturizer, especially if you have any underlying health conditions or are taking other medications.

As you or your loved ones age, skin can become more sensitive, so it’s important to monitor how your skin reacts to new products. If you notice any irritation or unusual changes, discontinue use and seek advice from a healthcare provider.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

Drug Interactions

It's important to be cautious when using multiple acne treatments at the same time. If you apply another topical acne medication along with 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 quality and effectiveness.

When handling the product, always do so with care to avoid any damage. Following these simple storage and handling tips 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 too dry or irritated?

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

Are there any warnings I should be aware of?

This product is for external use only. Skin irritation and dryness may occur, especially if used with other topical acne medications.

What should I do if I swallow this product?

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

Is this product safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding use during pregnancy or nursing.

Are there any contraindications for this product?

No specific contraindications are mentioned for this product.

How should I store this product?

Protect the product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Byoma Acne Control Moisturizer.
Details

Drug Information (PDF)

This file contains official product information for Byoma Acne Control Moisturizer, 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 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.

It is advisable to initiate treatment with one application per day to minimize the risk of excessive drying of the skin. Based on the patient's response, 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 daily or every other day to alleviate these symptoms.

Contraindications

Use is contraindicated in patients who experience skin irritation that worsens upon application. In such cases, it is advised to discontinue use and consult a healthcare professional. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of multiple topical acne medications, as this may increase the likelihood of skin irritation and dryness. In the event that skin irritation occurs or worsens, patients should discontinue use and consult a healthcare provider for further guidance.

In cases of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Centre. 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 intended for external use only. The most commonly reported adverse reactions include skin irritation and dryness, which may be exacerbated if another topical acne medication is used concurrently. It is advised that patients limit the use of topical acne medications to one at a time to minimize the risk of irritation.

In the event that skin irritation occurs or worsens, patients are instructed to discontinue use and consult a healthcare professional for further guidance.

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 Moisturizer (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Byoma Acne Control Moisturizer.
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 Moisturizer 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

The safety of Byoma Acne Control Moisturizer during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals are advised to exercise caution when recommending this product to pregnant patients. There are no available studies or clinical data to assess potential risks or fetal impacts associated with the use of this moisturizer during pregnancy. Women of childbearing potential should be informed of the lack of safety information and encouraged to discuss any concerns with their healthcare provider before use.

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 information is available.

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 available information 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 lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Centre without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Centre immediately.

Patients should be informed to discontinue use and consult a doctor if they experience skin irritation that occurs or worsens during treatment. It is important to communicate that the likelihood of skin irritation and dryness may increase if the patient uses another topical acne medication concurrently. Therefore, patients should be instructed to 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 Moisturizer, 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 Moisturizer, 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.