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La Roche Posay Laboratoire Dermatologique Effaclar Antiacne Pore Refining Acn...

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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)
Marketed in the U.S.
Since 2022
Label revision date
December 13, 2023
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
Marketed in the U.S.
Since 2022
Label revision date
December 13, 2023
Manufacturer
COSMETIQUE ACTIVE PRODUCTION
Registration number
M006
NDC root
69625-528

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Drug Overview

This medication is designed to help clear acne blemishes and prevent new ones from forming. It works by penetrating the pores of your skin, effectively targeting the root causes of acne. If you're struggling with acne, this treatment may be a helpful option to consider for achieving 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. This can be done one to three times a day, depending on your needs and how your skin reacts.

To avoid excessive dryness, it’s best to start with just one application each day. If your skin tolerates it well, you can gradually increase to two or three times daily, but always 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. If you are considering this product for a child under 12 years old, be sure to consult a doctor first.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these issues. Always remember to follow your healthcare provider's guidance for the best outcomes.

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 instructions provided to ensure safe and effective use. If you have any concerns or experience unusual reactions, consult your healthcare provider.

Warnings and Precautions

This product is 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.

There are no specific general precautions or laboratory tests associated with this product, but it's always a good idea to follow the instructions provided and consult your healthcare provider if you have any concerns.

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 concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. It is generally not recommended for use due to potential risks to your developing baby. Salicylic acid, a key ingredient, may pose risks when used during pregnancy, so it's crucial to consult your healthcare provider for safer alternatives.

If you do consider using this product while pregnant, be aware that dosage adjustments may be necessary. Always seek medical advice before using it, and avoid using it unless specifically directed by a healthcare professional. Your health and the health of your baby should always come first.

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.

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

Pediatric Use

If you are considering this medication for a child under 12 years old, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for their specific age and health needs. Always prioritize professional guidance when it comes to the health of your children.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 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 recommended limits. 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 should apply this medication topically, covering the entire affected area with a thin layer one to three times a day. It's best to start with one application daily and then gradually increase to two or three times daily if needed or as directed by your doctor. If you experience bothersome dryness or peeling, reduce the application to once a day or every other day.

FAQ

What is the primary use of this drug?

This drug is used to clear acne blemishes and helps prevent new ones 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.

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.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended 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 drug?

No specific contraindications are listed, but consult a doctor if you are under 12 years of age.

How should I store this product?

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

Can I use this product if I am nursing?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for La Roche Posay Laboratoire Dermatologique Effaclar Antiacne 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 additional specific description details are provided in the available data.

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 drying of the skin, 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 a day 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 associated with the use of this product.

Side Effects

For external use only. Patients should be advised to avoid contact with eyes and mucous membranes. In the event of accidental contact, the affected area should be rinsed thoroughly with water. No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond this warning.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for La Roche Posay Laboratoire Dermatologique Effaclar Antiacne 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 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

Safety during pregnancy has not been established for this product. Use is not recommended during pregnancy due to potential risks to the fetus. Salicylic acid may pose risks when used during this period; therefore, it is essential for pregnant patients to consult a healthcare provider for alternatives.

Dosage adjustments may be necessary for pregnant individuals, and medical advice should be sought before use. Special precautions should be taken, as pregnant women should avoid using this product unless directed by a healthcare professional.

Lactation

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

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Supportive care is recommended, and symptomatic treatment should be initiated as necessary. Healthcare providers should consider the patient's clinical status and any co-administered medications that may influence the management of overdosage.

Due to the lack of detailed overdosage information, it is imperative for healthcare professionals to remain vigilant and utilize clinical judgment in the assessment and management of potential overdosage scenarios.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

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 medication is administered topically, with a recommended application of a thin layer to the entire affected area one to three times daily. Clinicians should advise patients to start with one application daily, gradually increasing to two or three times daily as needed or directed by a healthcare professional. In cases where bothersome dryness or peeling occurs, patients should reduce the frequency of application to once a day or every other day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for La Roche Posay Laboratoire Dermatologique Effaclar Antiacne 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 Antiacne 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

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.