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Salicylic acid

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Active ingredient
Salicylic Acid 0.02 g/1 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
July 24, 2025
Active ingredient
Salicylic Acid 0.02 g/1 g
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 2024
Label revision date
July 24, 2025
Manufacturer
Acne Free, LLC
Registration number
M006
NDC root
80861-117

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If you are a consumer or patient please visit this version.

Drug Overview

You can use this medication to help treat acne, a common skin condition that causes pimples and blemishes. While the specific details about how it works are not provided, it is often formulated to help clear the skin and prevent future breakouts.

In addition to the medication, an exfoliating scrub containing salicylic acid may be included, which can assist in removing dead skin cells and unclogging pores, further supporting your skin's health.

Uses

If you're dealing with acne, this medication can help you manage and treat your condition effectively. Acne is a common skin issue that can affect people of all ages, and using this treatment may lead to clearer skin and improved confidence. Always consult with your healthcare provider to ensure it's the right option for you.

Dosage and Administration

To use the scrub effectively, start by wetting your hands and face. Then, squeeze a small amount of the scrub into your hands and rub them together to create a lather. Gently apply the scrub to your face, massaging it in while being careful to avoid your eyes. If the scrub accidentally gets into your eyes, rinse them thoroughly with water to remove it.

After you’ve massaged the scrub into your skin, rinse your face well with water to wash away any residue. This process helps keep your skin clean and refreshed.

What to Avoid

It's important to be cautious when using topical acne medications. You should not use another topical acne treatment simultaneously, as this can increase the risk of skin irritation and dryness. If you experience any irritation, it's best to stick with just one topical acne medication at a time to help minimize these side effects.

Always prioritize your skin's health by following these guidelines to ensure a more effective and comfortable treatment experience.

Side Effects

When using this product, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize irritation, it’s best to use only one topical acne treatment at a time.

This product is for external use only, so keep it out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, be careful to avoid contact with your eyes; if it happens, rinse your eyes thoroughly with water.

Warnings and Precautions

This product is intended for external use only. While using it, be cautious about combining it with other topical acne medications, as this can increase the risk of skin irritation and dryness. If you experience irritation, it’s best to stop using all but one topical acne treatment at a time.

Make sure to keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately. Additionally, avoid getting the product in your eyes; if this happens, rinse your eyes thoroughly with water.

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

If you are pregnant or planning to become pregnant, it's important to be cautious with the use of salicylic acid, as its safety during pregnancy has not been established. There are potential risks to your developing baby, including the possibility of teratogenic effects (which means it could cause developmental issues). Because of these risks, salicylic acid is generally not recommended for use during pregnancy.

If you feel you need to use products containing salicylic acid, it's crucial to consult your healthcare provider first. They may suggest dosage modifications or alternative treatments to ensure the safety of both you and your baby. Always prioritize professional guidance when it comes to your health during pregnancy.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center. Taking quick action can be crucial in ensuring their safety. Always be vigilant and store medications securely to prevent any accidents.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver health.

Drug Interactions

It's important to be cautious when using this product alongside other topical acne medications. Using multiple acne treatments at the same time can increase the risk of skin irritation and dryness. If you notice any irritation, it's best to limit yourself to 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 to managing your acne while minimizing potential side effects.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How do I use the exfoliating scrub?

Wet your hands and face, squeeze the scrub into your hands, rub together, and apply to your face while massaging gently. Avoid contact with your eyes, and rinse thoroughly with water if contact occurs.

Are there any contraindications for this product?

Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus.

What should I do if I accidentally swallow this product?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this product with other topical acne medications?

Do not use another topical acne medication at the same time, as this may increase the risk of skin irritation and dryness.

Is this product safe to use during pregnancy?

The safety of salicylic acid during pregnancy has not been established, and it is advised to consult a healthcare provider before use.

What should I do if I experience skin irritation?

If irritation occurs, only use one topical acne medication at a time and consult a healthcare provider if necessary.

How should I store this product?

Store at room temperature and keep out of reach of children. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Salicylic Acid. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Salicylic Acid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is an exfoliating scrub designed for the removal of dead skin cells and impurities from the skin's surface. It is formulated to enhance skin texture and promote a smoother appearance. The scrub contains a blend of physical exfoliants that work to gently slough away dull skin, revealing a fresher complexion. The product is suitable for various skin types and is intended for topical application.

Uses and Indications

This drug is indicated for the treatment of acne. It is intended for use in patients diagnosed with acne vulgaris, providing therapeutic benefits in managing this dermatological condition.

Dosage and Administration

Healthcare professionals are advised to instruct patients to begin by wetting their hands and face. Following this, patients should squeeze an appropriate amount of the scrub into their hands and rub them together to create a lather. The scrub should then be applied to the face, where it should be massaged gently, taking care to avoid contact with the eyes. In the event of accidental contact with the eyes, it is essential to rinse thoroughly with water. After massaging, patients should rinse their face thoroughly to remove the scrub.

Contraindications

The use of this product is contraindicated in patients who are concurrently using another topical acne medication, as this may increase the risk of skin irritation and dryness. In the event of irritation, it is advised to limit the use to one topical acne medication at a time.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the concurrent use of this product with other topical acne medications may increase the likelihood of skin irritation and dryness. In cases where irritation occurs, it is recommended to limit the use to one topical acne medication at a time to mitigate adverse effects.

It is imperative to keep this product 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.

Healthcare providers should also caution patients to avoid contact with the eyes. Should contact occur, it is essential to flush the eyes thoroughly with water to prevent potential complications.

Side Effects

Patients using this product should be aware that it is for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time.

In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately. Additionally, patients should avoid contact with the eyes; should contact occur, it is recommended to flush the eyes thoroughly with water to mitigate potential adverse effects.

These precautions are essential to ensure the safe use of the product and to prevent serious complications.

Drug Interactions

The concurrent use of this product with other 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 skin 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 Salicylic Acid. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Salicylic Acid.
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 safety of salicylic acid during pregnancy has not been established, and its use is contraindicated due to potential risks to the fetus. There is a known risk of teratogenic effects associated with the use of salicylic acid during pregnancy. Therefore, pregnant patients should avoid using products containing salicylic acid unless directed by a healthcare professional.

Dosage modifications may be necessary for pregnant individuals, and it is advised that they consult a healthcare provider before use to ensure safety for both the mother and the developing fetus.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available 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.

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 of the patient's condition is essential.

Management procedures should include monitoring vital signs and providing supportive care as needed. In cases where the specific substance is known, appropriate antidotes or treatments should be administered as per established protocols.

It is vital for healthcare providers to remain vigilant and act swiftly to mitigate potential complications associated with 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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.

Patients should also be informed that the use of this product may increase the likelihood of skin irritation and dryness, particularly if they are using another topical acne medication 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 configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Salicylic Acid, 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 Salicylic Acid, 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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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.