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Lerosett Botanical Acne Cleanser

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Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
June 27, 2024
Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
June 27, 2024
Manufacturer
GUNILLA OF SWEDEN, INC.
Registration number
M006
NDC root
84463-507

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Drug Overview

This medication is used for the treatment of acne, a common skin condition that can cause blemishes. It works by penetrating the pores to help clear existing acne blemishes and prevent the formation of new ones, including pimples, blackheads, and whiteheads. By keeping your skin clear, it aims to improve your overall complexion and reduce the frequency of breakouts.

Uses

If you're dealing with acne, this treatment can be a helpful option for you. It works by penetrating deep into your pores to clear up most acne blemishes, helping to improve the overall appearance of your skin.

In addition to treating existing acne, this medication also helps to keep your skin clear by preventing new acne pimples, blackheads, and whiteheads from forming. With consistent use, you can achieve clearer skin and reduce the frequency of breakouts.

Dosage and Administration

To use this medication effectively, start by wetting the skin in the areas you want to cleanse. Apply a thin layer of the medication to the entire affected area, doing this one to three times a day based on your needs or your doctor's advice. Gently massage the medication into your skin until it forms a full lather, then rinse it off thoroughly with plain water.

After rinsing, pat your skin dry. If you're just starting, it's best to begin with one application each day. You can gradually increase to two or three times daily if necessary. However, 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 mindful of how you use this medication. If you experience severe irritation, you should stop using it and consult your doctor for guidance. Additionally, to prevent increased skin irritation and dryness, make sure to use only one topical acne medication at a time.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and the effectiveness of your treatment.

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 this risk, it’s best to use only one topical acne treatment at a time. If you notice that the irritation becomes severe, stop using the product and consult a doctor.

This product is for external use only. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help immediately or contact a Poison Control Center.

Be cautious if you are using other topical acne medications, as combining them with this product can increase the risk of skin irritation and dryness. It’s best to use only one topical acne treatment at a time to minimize these effects.

If you experience severe irritation while using this product, stop using it and consult your doctor for further advice.

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 calling your local 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 drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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. If you are pregnant or breastfeeding, consult a healthcare professional before using this medication.

When applying the medication to your child's skin, start with one application each day. You can gradually increase to two or three times a day if necessary, but be cautious. If you notice any bothersome dryness or peeling, reduce the application to once a day or every other day. Always follow your doctor's guidance for the best results.

Geriatric Use

When using LEROSETT Botanical Acne Cleanser, there is no specific information available regarding its use in older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new product, especially if there are existing health conditions or medications involved. This ensures that you can use the product safely and effectively.

Renal Impairment

If you have kidney problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, monitoring, or safety considerations for your condition. This means that there are no special guidelines mentioned for how this medication may affect you or how it should be adjusted based on your kidney function.

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 needs.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication should be used in patients with liver impairment.

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to be cautious when using multiple acne treatments. If you apply another topical acne medication at the same time or right after using this product, you may experience increased skin irritation and dryness. To avoid 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 how to use these products safely and effectively, ensuring you get the best results without 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

You should apply this medication topically to the areas that need cleansing, using a thin layer one to three times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, if you plan to go outside after application, make sure to use sunscreen. If you experience any irritation or sensitivity, stop using both the medication and sunscreen, and consult your doctor.

FAQ

What is this medication used for?

This medication is used for the treatment of acne.

How does this medication work?

It penetrates pores to clear most acne blemishes and helps keep skin clear of new acne pimples, blackheads, or whiteheads.

How should I apply this medication?

Wet the skin and apply a thin layer to the affected areas one to three times daily, massaging gently into a full lather before rinsing thoroughly.

What should I do if I experience dryness or peeling?

If bothersome dryness or peeling occurs, 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. If irritation becomes severe, stop use and ask a doctor.

Can I use other topical acne medications with this product?

You should use only one topical acne medication at a time to avoid increased skin irritation and dryness.

What should I do if I swallow this medication?

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

Is this medication safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store this medication?

Protect the product from excessive heat and direct sunlight.

Packaging Info

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

Packaging configurations for Lerosett Botanical Acne Cleanser.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the treatment of acne. It penetrates the pores to effectively clear most acne blemishes and helps maintain skin clarity by preventing the formation of new acne pimples, blackheads, or whiteheads.

Dosage and Administration

The skin should be wetted prior to the application of the medication. A thin layer of the product should be applied to the entire affected area one to three times daily, depending on the patient's needs or as directed by a healthcare professional. The medication should be gently massaged into the skin until a full lather is achieved. Following application, the area must be rinsed thoroughly with plain water. After rinsing, the skin should be patted dry.

Initial treatment should begin with one application per day. Based on the patient's response, the frequency may be gradually increased to two or three times daily. In cases where bothersome dryness or peeling occurs, it is advisable to reduce the application frequency to once daily or every other day.

Contraindications

Use is contraindicated in patients who experience severe irritation from the product, as discontinuation and consultation with a healthcare professional are advised under such circumstances. Additionally, the concurrent use of multiple topical acne medications is contraindicated to prevent the risk of increased skin irritation and dryness.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of this product with other topical acne medications, as this may increase the risk of skin irritation and dryness. It is recommended that patients use only one topical acne medication at a time to minimize these 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 Center without delay.

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 another topical acne medication or immediately following its application. In such cases, it is advised to limit the use to one topical acne medication at a time to minimize the risk of these reactions.

Participants are instructed to stop using the product and consult a healthcare professional if irritation becomes severe. Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact with a Poison Control Center is recommended.

For patients who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Drug Interactions

The concurrent use of this product with other topical acne medications may increase the risk of skin irritation and dryness. To mitigate these effects, it is advised that only one topical acne medication be used at a time. This approach will help minimize the potential for adverse skin reactions.

Packaging & NDC

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

Packaging configurations for Lerosett Botanical Acne Cleanser.
Details

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

For pediatric patients, it is recommended to start with one application daily to minimize the risk of excessive skin drying. The frequency of application may be gradually increased to two or three times daily as needed or directed by a healthcare professional. If bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Healthcare professionals should advise caregivers to consult with a health professional if the patient is pregnant or breastfeeding before using this product.

Geriatric Use

Elderly patients may not have specific information regarding the use of LEROSETT Botanical Acne Cleanser, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population. Therefore, healthcare providers should exercise caution when considering the use of this product in geriatric patients, as individual responses may vary. Monitoring for any adverse effects or unusual reactions is advisable when administering this cleanser to elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function in the provided drug insert text. Healthcare professionals should exercise caution and consider individual patient factors when prescribing this medication to patients with renal impairment.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful evaluation and monitoring based on individual patient circumstances.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience severe irritation. It is important to highlight that skin irritation and dryness may be more likely to occur if patients use another topical acne medication concurrently or immediately after using this product. Therefore, patients should be encouraged to use only one topical acne medication at a time to minimize the risk of adverse effects.

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

The medication is administered topically, with a recommendation to apply a thin layer to the affected area one to three times daily. Patients should be counseled to consult a health professional if they are pregnant or breastfeeding before use. Additionally, when going outdoors, it is advised to apply sunscreen after using the product. Should any irritation or sensitivity occur, patients are instructed to discontinue use of both the medication and sunscreen and to seek medical advice.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Lerosett Botanical Acne 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 Lerosett Botanical Acne 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.

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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.