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Acne Moisturizer

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Active ingredient
Salicylic Acid 0.5 mg/50 mL
Other brand names
Dosage form
Cream
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 0.5 mg/50 mL
Other brand names
Dosage form
Cream
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
68062-9907

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

If you're looking for a treatment for acne, this medication is designed specifically for that purpose. It helps to reduce the appearance of acne, which can be a common skin condition affecting many people. While the exact way it works isn't detailed, its primary goal is to improve your skin's condition and help you feel more confident.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating and affect your confidence, but this treatment aims to reduce breakouts and improve the overall appearance of your skin.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for many individuals. Always consult with your healthcare provider to determine if this treatment is right for you.

Dosage and Administration

Before using this product, make sure to clean your skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire affected area. You can start by using it once a day. If you feel comfortable and your doctor recommends it, you can gradually increase the application to two or three times a day.

Keep an eye on how your skin reacts. If you notice any bothersome dryness or peeling, it’s a good idea to reduce your application to once a day or even every other day. This way, you can find the right balance that works for you while still treating the affected area effectively.

What to Avoid

It's important to keep this product out of reach of children. If a child accidentally ingests it, seek medical help or contact a Poison Control Center immediately. Additionally, if you experience any irritation while using this product, make sure to use only one topical acne medication at a time to avoid further irritation.

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

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

Overdose

If you or someone else has swallowed too much of this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to approach the use of this product with caution. While the product is not specifically listed as unsafe for use during pregnancy, there are no clear statements about potential risks to the fetus or specific safety concerns. This means that while it may not be contraindicated, you should still be careful and consult with your healthcare provider.

Additionally, the product insert does not recommend any changes to the dosage for pregnant individuals, nor does it outline any special precautions for use during pregnancy. Always discuss your options with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients could be passed into your breast milk, so caution is advised.

The effects on your nursing infant have not been thoroughly studied, which means you should carefully weigh the potential risks against the benefits of using this product. Always prioritize your and your baby's health by seeking professional guidance.

Pediatric Use

It's important to keep this medication out of reach of children to prevent any accidental ingestion. If a child accidentally takes this medication, you should 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

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your treatment and any necessary adjustments. Always keep them informed about your kidney health to ensure safe and effective care.

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 (issues with liver function).

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 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 full list of medications and any health concerns during your appointments to receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the container tightly closed. It's important to protect the product from light to maintain its effectiveness. Once you open the container, be sure to discard any remaining contents, as they should not be reused. Following these guidelines will help you use the product safely and effectively.

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 necessary 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 this product used for?

This product is used for the treatment of acne.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily. Start with one application daily and gradually increase 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.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes, and if swallowed, seek medical help immediately.

Is this product safe to use during pregnancy?

The product is not specifically contraindicated in pregnancy, but caution is advised. Consult your healthcare provider for personalized advice.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally ingest this product?

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

How should I store this product?

Store at room temperature, keep the container tightly closed, and protect it from light. Discard after opening.

Packaging Info

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

Packaging configurations for Acne Moisturizer.
Details

Drug Information (PDF)

This file contains official product information for Acne Moisturizer, 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. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to ensure that the skin is thoroughly cleaned prior to the application of this product. The affected area should be covered with a thin layer of the product, applied one to three times daily.

Initial treatment should commence with one application per day. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once daily or every other day to mitigate these effects.

Contraindications

Use is contraindicated in the following situations:

Keep out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. Additionally, if irritation occurs, it is advised to use only one topical acne medication at a time to prevent exacerbation of symptoms.

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.

This product must be kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that the product is for external use only. It is imperative 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 worsens, patients are 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 the use of 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 Moisturizer (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Moisturizer.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The product is not specifically contraindicated in pregnancy; however, caution is advised when prescribing to pregnant patients. Currently, there are no explicit statements regarding risks to the fetus or specific safety concerns during pregnancy. Additionally, the prescribing information does not provide any dosage modifications for pregnant individuals. There are no special precautions outlined for the use of this product during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for women of childbearing potential.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on a nursing infant are not well studied; thus, the risks versus benefits should be considered.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to ensure optimal stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

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 per day, 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 Acne Moisturizer, 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 Moisturizer, 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.