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La Roche Posay Effaclar Medicated 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 2022
Label revision date
July 8, 2025
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 2022
Label revision date
July 8, 2025
Manufacturer
L'Oreal USA Products Inc
Registration number
M006
NDC root
49967-402

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Drug Overview

This medication is used for the treatment of acne, a common skin condition that causes pimples and other blemishes. While specific details about how the drug works are not provided, it is designed to help improve the appearance of your skin by targeting the underlying causes of acne. If you're struggling with acne, this treatment may be a helpful option to consider.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating, but with the right treatment, you can see improvements in your skin's appearance and health.

It's important to note that this medication does not have any known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential risks while seeking effective acne treatment.

Dosage and Administration

To use this product effectively, start by wetting your face with water. Then, take a small amount of the product and work it into a lather using your hands. Gently massage the lather onto your face, but be careful to avoid your eyes. After you’ve applied it, rinse your face thoroughly with water.

For the best results, make sure to use this product twice a day. This routine will help keep your skin clean and refreshed.

What to Avoid

It's important to be aware of specific instructions regarding the use of 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 listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always follow the guidance provided to ensure safe use.

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, consult your healthcare provider.

Warnings and Precautions

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

If you experience any irritation while using this product, stop using it and consult your doctor. It's important to use only one topical acne medication at a time to prevent potential skin issues.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the safety or use of this product during pregnancy. This means that there are no established guidelines regarding its safety, dosage adjustments, or any special precautions you should take while pregnant.

Always consult with your healthcare provider before using any medication or product during pregnancy to ensure the best care for you and your baby. Your doctor can help you weigh the potential risks and benefits based on your individual situation.

Lactation Use

There is no specific information available about the use of LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER for nursing mothers or during lactation. This means that if you are breastfeeding, it’s important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize your health and your infant's well-being when considering any new skincare products.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

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 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 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 and safety of your product, store it at room temperature and keep it tightly closed when not in use. It's important to protect it from excessive heat, as high temperatures can affect its effectiveness. Avoid freezing the product, as this can also compromise its quality. If the instructions specify, be sure to discard the product after opening to maintain safety and efficacy. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using it twice a day for best results. Be aware that using this product alongside another topical acne treatment can increase the chances of skin irritation and dryness. If you experience irritation, it's advisable to stop using one of the medications to help alleviate the issue.

FAQ

What is the drug used for?

The drug is used for the treatment of acne.

How should I use the product?

You should wet your face, work the product into a lather, massage it onto your face while avoiding the eyes, and then rinse well. Use it twice daily.

Are there any warnings I should be aware of?

Yes, the product is for external use only. If swallowed, get medical help or contact a Poison Control Center right away.

What should I do if I experience irritation?

If irritation occurs, you should only use one topical acne medication at a time.

Is there any information regarding use during pregnancy?

The product has not been specifically mentioned in relation to pregnancy use or safety concerns.

How should I store the product?

Store the product at room temperature, keep it tightly closed when not in use, protect it from excessive heat, and do not freeze.

What should I do if the product is swallowed?

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

Is there any information about using this product with other acne medications?

Yes, skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time.

Are there any contraindications for this product?

No contraindications are listed for this product.

Is there any information regarding use in elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

Below are the non-prescription pack sizes of La Roche Posay Effaclar Medicated Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for La Roche Posay Effaclar Medicated Cleanser.
Details

Drug Information (PDF)

This file contains official product information for La Roche Posay Effaclar Medicated Cleanser, 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 this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

The product is to be used twice daily. Prior to application, the patient should wet their face thoroughly. A sufficient amount of the product should then be worked into a lather. The lather should be gently massaged onto the face, taking care to avoid contact with the eyes. After massaging, the product must be rinsed off well with water.

Contraindications

There are no specific contraindications listed 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. It is imperative that this product is not ingested. In the event of accidental swallowing, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

In cases where irritation occurs, it is advised to discontinue use and consult a healthcare professional. Furthermore, to minimize the risk of adverse effects, patients should refrain from using multiple topical acne medications concurrently. This precaution is essential to ensure safe and effective treatment outcomes.

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 beyond the stated warning.

Drug Interactions

Concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the use of topical acne treatments to one at a time to minimize the potential for adverse effects. If irritation occurs, the patient should discontinue the use of additional topical acne medications and consult a healthcare professional for further guidance.

Packaging & NDC

Below are the non-prescription pack sizes of La Roche Posay Effaclar Medicated Cleanser (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for La Roche Posay Effaclar Medicated Cleanser.
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 the Poison Control Center should be contacted without delay.

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 product has not been specifically studied in pregnant patients, and therefore, there are no established safety concerns, dosage modifications, or special precautions regarding its use during pregnancy. Given the lack of data, healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for women of childbearing potential. It is advisable to monitor pregnant patients closely if this product is deemed necessary.

Lactation

There is no specific information regarding the use of LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate management strategies.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are paramount in managing potential overdose situations.

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.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is crucial for patients to understand the potential risks associated with accidental ingestion.

Additionally, healthcare providers should inform patients about the likelihood of skin irritation and dryness when using this medication in conjunction with other topical acne treatments. Patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation. This guidance will help ensure safe and effective use of the medication while reducing the potential for adverse skin reactions.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from excessive heat sources. To maintain product integrity, it is essential to keep the container tightly closed when not in use. Freezing the product is strictly prohibited, as it may compromise its effectiveness. If specified, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically and should be applied twice daily. Clinicians should counsel patients that the use of another topical acne medication concurrently may increase the likelihood of skin irritation and dryness. In cases of irritation, it is advised to limit the use to one topical acne medication at a time. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for La Roche Posay Effaclar Medicated 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 La Roche Posay Effaclar Medicated 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.