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Phyla Acne Phage Serum

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Active ingredient
Salicylic Acid 5 mg/100 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
December 31, 2025
Active ingredient
Salicylic Acid 5 mg/100 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
December 31, 2025
Manufacturer
COSMAX USA, CORP
Registration number
M006
NDC root
68577-230

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Drug Overview

This medication is used for the treatment of acne, helping to clear up acne blemishes and allowing your skin to heal. It is designed to improve the appearance of your skin by targeting the underlying causes of acne. If you're struggling with acne, this treatment may be a supportive option to consider for clearer skin.

Uses

If you're dealing with acne, this medication can be a helpful option for you. It is specifically designed to treat acne by clearing up blemishes and promoting the healing of your skin. With consistent use, you may notice a significant improvement in your skin's appearance and overall health.

Dosage and Administration

Before you start using the 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 what works best for you.

To avoid excessive drying of your skin, it’s a good idea to begin with just one application each day. After a few days, if your skin tolerates it well, you can gradually increase the frequency to two or three times daily, or follow your doctor's advice. If you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day to help your skin adjust.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence (a condition where your body becomes reliant on a substance) associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

This product is intended for external use only. While using it, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize irritation, it’s best to use only one topical acne treatment at a time.

Please keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This medication 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.

Be cautious if you are using other topical acne treatments at the same time, as this can increase the risk of skin irritation and dryness. To minimize these effects, it’s best to use only one topical acne medication at a time. If you experience any irritation, consider stopping the use of the other product.

Overdose

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

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, it’s always better to be safe and get checked out if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Given this lack of information, it is advisable to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can use Phyla Acne Phage Serum without specific warnings or recommendations against it. The information available does not indicate any concerns about the product being present in breast milk or any risks to your infant while using it during lactation.

As always, if you have any concerns or questions about using new products while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

When using this medication on children, start with just one application per day to avoid excessive drying of the skin. You can gradually increase to two or three applications daily, but only if directed by a doctor. Always follow your healthcare provider's instructions to ensure safe and effective use.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Since there are no dosage adjustments or special precautions outlined for elderly patients, your healthcare provider will be the best resource for determining the appropriate use of this medication based on individual health needs. Always ensure that any treatment plan is tailored to your specific situation.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your full list of medications and any health concerns during your appointments to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to avoid exposing it to high temperatures, as well as protecting it from freezing conditions. Additionally, keep the product away from any sources of flame, fire, and heat to prevent damage or hazards. By following these simple storage guidelines, you can help maintain the quality and safety of the device.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the treatment of acne, helping to clear up acne blemishes and allowing the skin to heal.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the entire 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 the 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 if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication.

What should I do if I accidentally swallow this product?

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

What precautions should I take when using this product?

This product is for external use only. Keep it out of reach of children and avoid high temperatures, freezing, and flames.

Is there any information regarding use during pregnancy or lactation?

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation.

Packaging Info

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

Packaging configurations for Phyla Acne Phage Serum.
Details

Drug Information (PDF)

This file contains official product information for Phyla Acne Phage Serum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the treatment of acne. It helps clear up acne blemishes and facilitates the healing of the skin.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of the product. The affected area should be covered with a thin layer of the product one to three times daily, depending on the patient's response and as directed by a physician.

It is recommended to initiate treatment with one application per day to minimize the risk of excessive drying of the skin. Based on the patient's tolerance, the frequency of application may be gradually increased to two or three times daily.

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

Contraindications

There are no specific contraindications identified for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to apply the product solely to the skin and avoid ingestion.

Skin irritation and dryness may be exacerbated when this product is used concurrently with other topical acne medications. It is recommended that only one topical acne treatment be utilized at a time to minimize the risk of irritation. Should any signs of skin irritation occur, patients should discontinue use and consult a healthcare provider for further guidance.

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

No specific laboratory tests are required for monitoring the safe use of this product.

Side Effects

Patients using this product should be aware that it is for external use only. The application of this medication may lead to skin irritation and dryness, particularly if used concurrently with another topical acne medication. In such cases, it is advised to limit the use to one topical acne treatment at a time to minimize the risk of irritation.

Additionally, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Phyla Acne Phage Serum.
Details

Pediatric Use

Pediatric patients should be monitored closely to ensure the medication is kept out of reach, as ingestion may require immediate medical attention or contact with a Poison Control Center.

To minimize the risk of excessive skin drying, it is recommended to initiate treatment with one application daily. The frequency may be gradually increased to two or three times daily, or as directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients.

It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively in elderly patients.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

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

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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

Overdosage

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

Healthcare professionals should be aware that prompt intervention can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management procedures should include a thorough assessment of the patient's condition, including vital signs and any presenting symptoms. Supportive care may be necessary, and specific treatment protocols should be followed based on the substance involved and the severity of the overdosage.

In all cases, timely communication with poison control and adherence to established medical guidelines are recommended to ensure optimal patient care.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 Center immediately.

Patients should be informed that the use of this product may increase the likelihood of skin irritation and dryness, particularly if they are using another topical acne medication concurrently. It is important to counsel patients to use only one topical acne medication at a time to minimize the risk of irritation. If patients experience any signs of irritation, they should discontinue use and consult their healthcare provider for further guidance.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that it is kept away from high temperatures. Additionally, the product must be protected from freezing conditions. Care should be taken to keep the product away from flame, fire, and heat sources to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Phyla Acne Phage Serum, 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 Phyla Acne Phage Serum, 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.