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La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment

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Active ingredient
Salicylic Acid 15 mg/1 mL
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 2022
Label revision date
December 13, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 15 mg/1 mL
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 2022
Label revision date
December 13, 2023
Manufacturer
L'Oreal USA Products Inc
Registration number
M006
NDC root
49967-529
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication is designed to help you manage acne by clearing existing blemishes and preventing new ones from forming. It works by penetrating the pores of your skin, effectively controlling acne breakouts. If you're struggling with acne, this treatment may be a helpful option to consider for clearer skin.

Uses

If you're dealing with acne, this treatment can help clear up blemishes and prevent new ones from forming. It works by penetrating deep into your pores to effectively control existing acne. By using this product, you can take a proactive step towards achieving clearer skin.

Dosage and Administration

Before using this product, make sure to clean the affected area of your skin thoroughly. You should apply a thin layer of the product to the entire area that needs treatment. Initially, 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, but only if needed or as advised by your doctor.

Be mindful that using this product too often may lead to excessive dryness of your skin. If you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day. If you are considering this product for a child under 12 years of age, be sure to consult a doctor first.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it’s appropriate for your individual health needs. If you have any concerns or questions about this medication, don’t hesitate to reach out to your doctor or pharmacist for guidance.

Side Effects

It's important to note that this product is for external use only. This means you should not apply it to your eyes, mouth, or any internal areas. Always follow the guidelines for safe use to avoid any potential issues. If you have any concerns or experience unusual reactions, please consult a healthcare professional.

Warnings and Precautions

This product is intended for external use only, so please avoid ingesting it. If you accidentally swallow any of it, seek emergency medical help or contact a Poison Control Center immediately.

Currently, there are no specific general precautions or laboratory tests associated with this product. However, it's always a good idea to stay informed and consult with your healthcare provider if you have any concerns or questions about its use.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of salicylic acid has not been established. This ingredient is generally not recommended during pregnancy due to potential risks to your developing baby. If you feel that you need to use a product containing salicylic acid, it should only be done after discussing it with your healthcare provider, who can help weigh the benefits against any possible risks.

Always consult your doctor before using any medication or treatment during pregnancy to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their needs.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment.

When determining the right dosage for you, your healthcare provider will consider your creatinine clearance, which is a measure of how well your kidneys are filtering waste from your blood. Always communicate with your doctor about your kidney health to ensure you receive the best care possible.

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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the ideal range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences related to this medication. If you have any questions or concerns about how to use it, be sure to consult your healthcare provider.

FAQ

What is the primary use of this drug?

This drug is used to clear acne blemishes, penetrate pores to control them, and help prevent new blemishes from forming.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily, starting with one application daily and increasing as needed.

What should I do if I experience dryness or peeling?

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

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What should I do if I swallow this product?

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

Are there any contraindications for using this product?

There are no specific contraindications listed, but it is advised to consult a doctor for children under 12 years of age.

How should I store this product?

Store the product at 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment.
Details

Drug Information (PDF)

This file contains official product information for La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the treatment of acne vulgaris. It effectively clears existing acne blemishes and penetrates pores to control the formation of acne lesions. Additionally, this drug helps prevent the emergence of new acne blemishes.

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 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 skin drying, it is advisable to initiate treatment with one application per day. 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, the application frequency should be reduced to once daily or every other day.

For patients under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent any adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay.

No additional general precautions or laboratory tests have been specified; however, healthcare providers should remain vigilant and monitor patients for any unusual reactions or side effects during the course of treatment.

Side Effects

For external use only. Patients should be advised to avoid contact with eyes and mucous membranes. In the event of accidental contact, thorough rinsing with water is recommended. No specific adverse reactions have been reported in clinical trials or postmarketing experiences; however, caution is advised to prevent misuse.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available 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 safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of salicylic acid during this period, and it should be used only if clearly needed, with careful consideration of whether the benefits outweigh the risks. Pregnant women are advised to consult a healthcare provider before using this product to ensure appropriate guidance and management.

Lactation

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

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, clinicians should consider creatinine clearance when determining the appropriate dosage for patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken promptly.

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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment, 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 La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment, 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

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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.