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Biore

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Active ingredient
Salicylic Acid 1 g/100 g
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
August 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 1 g/100 g
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
August 31, 2025
Manufacturer
Kao USA Inc.
Registration number
M006
NDC root
10596-199
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

Biore is a liquid acne treatment designed to help you manage breakouts effectively. It comes in the form of an invisible pimple patch that contains salicylic acid, a common ingredient known for its ability to penetrate pores and reduce acne. This product is specifically formulated to target acne, making it a convenient option for those looking to treat pimples discreetly.

Uses

If you're dealing with acne, this medication can help you manage and treat your condition effectively. It's designed specifically for the treatment of acne, providing you with a potential solution to improve your skin's appearance.

It's important to note that this medication has no teratogenic effects, meaning it does not cause birth defects if used during pregnancy. Additionally, there are no nonteratogenic effects mentioned, which indicates that it is generally safe in terms of causing other types of harm. Always consult with your healthcare provider for personalized advice and treatment options.

Dosage and Administration

Before using this product, make sure to clean the affected area of your skin thoroughly. You will then apply a thin layer of the product to the entire area using the applicator tip. It's recommended 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, but only if needed or as advised by your doctor.

Be mindful that using this product too often may lead to excessive drying of your skin. 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. Always listen to your body and consult with your healthcare provider if you have any concerns.

What to Avoid

It's important to use this medication safely. You should never apply it to damaged or broken skin, as this can lead to further complications. If you experience any rash or irritation while using the product, please discontinue use immediately.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. It's crucial to follow these guidelines to ensure your safety and well-being.

Side Effects

When using this product, you should be aware that it 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. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time.

Additionally, avoid applying the product to damaged or broken skin. If you notice any rash or irritation, it’s important to stop using the product immediately.

Warnings and Precautions

This product is for external use only. Be cautious if you are using other topical acne medications at the same time, as this can increase the risk of skin irritation and dryness. If you experience any rash or irritation, stop using the product immediately and consult your doctor.

Avoid applying the medication to damaged or broken skin. If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center right away. Always prioritize your safety and well-being when using any medication.

Overdose

If you or someone else has swallowed too much of a medication, it's important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

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 seek assistance if you suspect an overdose.

Pregnancy Use

While the information provided does not specify any particular safety concerns or precautions for use during pregnancy, it is always important to consult with your healthcare provider before taking any medication. They can provide personalized advice based on your health and pregnancy status.

Currently, there are no dosage modifications recommended for pregnant individuals, and no specific guidelines are mentioned regarding the use of this medication during pregnancy. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there are no specific guidelines or statements regarding the use of this medication during nursing. This means that the effects on breast milk production and the nursing infant have not been clearly established.

As always, it's best to consult with your healthcare provider for personalized advice and to discuss any concerns you may have about medications while breastfeeding. They can help you weigh the benefits and risks based on your individual situation.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center. Taking quick action can help ensure their safety. Always be vigilant and store medications securely to prevent any accidents.

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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially if there are existing health conditions or medications involved. Always prioritize safety and open communication with your medical team.

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 treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

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

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, store it at room temperature. This helps maintain its quality and performance. Additionally, it's important to keep the product out of reach of children to prevent any accidental misuse or ingestion. By following these simple guidelines, you can help ensure safe handling and storage.

Additional Information

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. This ensures that any potential risks are addressed quickly and effectively.

Currently, there are no additional details available regarding laboratory tests, abuse potential, or the specific ways this medication should be administered.

FAQ

What is Biore?

Biore is a liquid pimple patch treatment for acne that contains Salicylic Acid and is designed to be an invisible acne treatment.

How should I use Biore?

Clean the skin thoroughly before applying Biore. Cover the affected area with a thin layer 1 to 3 times daily using the applicator tip.

What should I do if I experience dryness or irritation?

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

Are there any contraindications for using Biore?

Do not apply Biore to damaged or broken skin, and discontinue use if rash or irritation occurs.

Is Biore safe to use during pregnancy?

The provided information does not mention any specific safety concerns regarding the use of Biore during pregnancy.

What precautions should I take when using Biore?

For external use only. Avoid using another topical acne medication at the same time to reduce the risk of skin irritation and dryness.

What should I do if I swallow Biore?

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

How should I store Biore?

Store Biore at room temperature and keep it out of reach of children.

Packaging Info

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

Packaging configurations for Biore.
Details

Drug Information (PDF)

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

View product document (PDF)

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 method of application involves covering the entire affected area with a thin layer, utilizing the applicator tip.

Initial dosing should begin with one application daily to minimize the risk of excessive drying of the skin. Based on the patient's response and as directed by a physician, 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 maintain skin integrity and comfort.

Contraindications

Application is contraindicated on damaged or broken skin. Discontinue use if rash or irritation occurs.

Warnings and Precautions

For external use only.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. It is advised that only one topical acne treatment be utilized at a time to minimize the risk of irritation. Application to damaged or broken skin is contraindicated. Should any rash or irritation develop, the product should be discontinued immediately.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should instruct patients to discontinue use and consult their physician if any rash or irritation occurs during treatment.

Side Effects

Patients using this product should be aware that it is intended for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of these reactions, it is advised that patients use only one topical acne medication at a time.

Additionally, patients should avoid applying the product to damaged or broken skin. In the event of a rash or irritation, discontinuation of use is recommended. These precautions are essential to ensure the safety and efficacy of the treatment.

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 one of the medications is recommended to alleviate symptoms. Monitoring for signs of skin irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

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

Packaging configurations for Biore.
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 Center is recommended.

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 available data regarding the use of this medication during pregnancy is limited. There are no specific safety concerns outlined in the prescribing information that would contraindicate its use in pregnant patients. Additionally, there are no dosage modifications recommended for individuals who are pregnant.

Healthcare professionals should remain vigilant and consider the overall clinical context when prescribing this medication to women of childbearing potential. As with any medication, the benefits and risks should be carefully weighed, and patients should be counseled accordingly.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or during lactation. Consequently, the effects on breastfed infants and the excretion of the drug in human milk remain undetermined. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action 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 of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 seek medical help or contact a Poison Control Center immediately.

Patients should be informed that the use of this medication in conjunction with other topical acne treatments may increase the likelihood of skin irritation and dryness. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients not to apply the medication to damaged or broken skin. Patients should be advised to discontinue use if any rash or irritation occurs, and to consult their healthcare provider for further guidance.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. Additionally, it is imperative to keep the product out of reach of children to ensure safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Biore, 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 Biore, 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.