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Acne Cleanser

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Active ingredient
Salicylic Acid 1.15 mg/230 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
January 20, 2026
Active ingredient
Salicylic Acid 1.15 mg/230 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 2023
Label revision date
January 20, 2026
Manufacturer
Spa de Soleil
Registration number
M006
NDC root
68062-9905

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Drug Overview

This medication is used for the treatment of acne, a common skin condition that can cause pimples, blackheads, and other blemishes. While specific details about how it works are not provided, it is designed to help improve the appearance of your skin by addressing 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 can help you manage and treat your condition. Acne is a common skin issue that can affect people of all ages, and this treatment is specifically designed to reduce breakouts and improve the overall appearance of your skin. By targeting the factors that contribute to acne, it aims to provide you with clearer skin and boost your confidence.

Dosage and Administration

To take care of the affected area, you should wash it twice a day. This regular cleaning helps keep the area clean and can support your healing process. Make sure to follow this routine consistently for the best results.

What to Avoid

It's important to be cautious when using this product. You should not use another topical acne medication at the same time, as this can lead to skin irritation and excessive dryness. If you experience any irritation, it's best to stop using all topical acne treatments and consult with a healthcare professional.

Always prioritize your skin's health by following these guidelines to avoid complications. If you have any concerns or questions about your treatment, don't hesitate to reach out to your healthcare provider for personalized advice.

Side Effects

It's important to be aware of some warnings associated with this product. It is for external use only, so avoid getting it in your eyes; if that happens, rinse your eyes thoroughly with water. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately.

You should also be cautious of skin irritation. If you experience excessive irritation or if it worsens, stop using the product and consult a doctor. Lastly, keep this product out of reach of children to ensure their safety.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. Be careful to keep it away from your eyes; if it accidentally gets in your eyes, rinse them thoroughly with water. If you swallow the product, seek medical help immediately or contact a Poison Control Center.

It's important to monitor your skin for any signs of excessive irritation. If you notice increased irritation, stop using the product and consult your doctor. Always keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center right away.

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 contacting a 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 seek assistance if you suspect an overdose.

Pregnancy Use

The safety of salicylic acid during pregnancy has not been established, and it is generally advised against its use. There are potential risks to the fetus, including the possibility of teratogenic effects, which are abnormalities that can occur during fetal development.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using any products containing salicylic acid. They can help you understand the risks and explore safer alternatives for your skincare needs.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers in the information provided. Additionally, there are no particular considerations or precautions mentioned for lactation (the process of producing milk). This suggests that the use of the medication may not pose significant risks to you or your nursing infant. However, it's always a good idea to consult with your healthcare provider about any concerns you may have while breastfeeding.

Pediatric Use

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

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, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on renal impairment. However, it’s always a good idea to discuss your kidney health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any changes in your kidney function, as they may need to adjust your treatment plan accordingly. Regular check-ups and open communication are key to managing your health safely.

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 you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best use of your product, store it at room temperature, away from direct sunlight and moisture. It's important to keep it out of reach of children to prevent accidental ingestion or misuse. Remember, this product is for external use only, so avoid applying it to any internal areas.

If the product accidentally comes into contact with your eyes, rinse them thoroughly with water to remove any residue. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for the treatment of acne.

How should I use this product?

You should wash the affected area twice daily.

Are there any precautions I should take while using this product?

Do not use another topical acne medication while using this product to avoid skin irritation and dryness.

What should I do if I experience excessive skin irritation?

If excessive skin irritation develops or increases, discontinue use and consult a doctor.

Is this product safe to use during pregnancy?

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

What should I do if I accidentally swallow this product?

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

What are the storage instructions for this product?

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

Can I use this product if I am nursing?

There are no specific warnings or recommendations regarding nursing mothers in the provided text.

What should I do if this product gets in my eyes?

Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Packaging Info

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

Packaging configurations for Acne Cleanser.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients with moderate to severe acne, as part of a comprehensive treatment plan.

Dosage and Administration

The affected area should be washed twice daily. Healthcare professionals are advised to instruct patients on the proper technique for cleansing the area to ensure optimal results. It is important to emphasize the need for consistency in the washing routine to achieve the desired therapeutic effect.

Contraindications

The use of this product is contraindicated in patients who are concurrently using another topical acne medication, as this may lead to increased skin irritation and dryness. To minimize the risk of adverse effects, it is advised that only one topical acne medication be used at a time.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes; should contact occur, the affected area must be rinsed thoroughly with water to mitigate potential irritation.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should monitor patients for signs of excessive skin irritation. If such irritation develops or worsens, the product should be discontinued, and a consultation with a physician is recommended.

Additionally, this product must be kept out of reach of children to prevent accidental exposure or ingestion.

Side Effects

Patients should be aware that the product is for external use only. It is important to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water. If the product is ingested, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

In clinical use, if excessive skin irritation develops or increases, it is advised to discontinue use and consult a healthcare professional. Additionally, the product should be kept out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Acne Cleanser.
Details

Pediatric Use

Pediatric patients should be monitored closely, as the product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the possibility of teratogenic effects. Pregnant women are advised to consult a healthcare provider before using this product to discuss potential risks and alternative treatment options.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned regarding lactation.

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 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 of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Providers should also inform patients that the use of this product may lead to skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is important to counsel patients to use only one topical acne medication at a time to minimize the risk of irritation. If patients experience any signs of irritation, they should discontinue use and consult their healthcare provider for further guidance.

Storage and Handling

The product is supplied in a configuration suitable for external use only. It is essential to store the product at room temperature to maintain its efficacy. Care should be taken to keep the product out of reach of children to prevent accidental ingestion or misuse. Additionally, users should avoid contact with the eyes; in the event of contact, it is advised to rinse thoroughly with water.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.