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Acne Spot Treatment

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Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 31, 2025
Active ingredient
Salicylic Acid 2 g/100 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 2016
Label revision date
December 31, 2025
Manufacturer
CONTROL CORRECTIVE SKINCARE INC
Registration number
M006
NDC root
70764-105

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Drug Overview

This product is an exfoliating gel designed to help reduce acne breakouts. By promoting the shedding of dead skin cells, it can help keep your pores clear and minimize the occurrence of new blemishes. If you're struggling with acne, this gel may be a beneficial addition to your skincare routine.

Uses

This exfoliating gel is designed to help reduce acne breakouts, making it a useful option for those struggling with this common skin condition. By promoting the shedding of dead skin cells, the gel can help clear pores and prevent new blemishes from forming.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this product, so it can be considered safe in that regard. If you're looking for a way to manage acne, this gel might be a beneficial addition to your skincare routine.

Dosage and Administration

To use this medication effectively, start by applying a small amount with your fingers to clean, dry skin. You can apply it all over the affected area or use it to spot treat specific blemishes.

If you experience any discomfort while using the product, it’s important to reduce how often you apply it or stop using it altogether. Always listen to your body and adjust your usage as needed for your comfort.

What to Avoid

You should not use this medication if you are allergic to aspirin. It's important to be aware of this contraindication to ensure your safety and avoid any adverse reactions. If you have any concerns or questions about your allergies or this medication, please consult your healthcare provider for guidance.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so you should not apply it to broken skin. Additionally, be careful to avoid contact with your eyes; if this happens, rinse your eyes thoroughly with water.

By following these precautions, you can help ensure a safer experience with the product. If you have any concerns or experience any unusual reactions, please consult a healthcare professional.

Warnings and Precautions

This product is for external use only, so please do not apply it to broken skin. Be careful to avoid getting it in your eyes; if that happens, rinse your eyes thoroughly with water.

Keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a poison control center immediately. Additionally, do not use this product if you are allergic to aspirin, as it could cause a serious reaction.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, you should call your local emergency number or go to the nearest hospital. Always keep your medications in their original packaging and follow the prescribed dosage to minimize the risk of an overdose. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

When it comes to using salicylic acid during pregnancy, there is no specific information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using products containing salicylic acid. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize your health and the health of your baby by seeking professional advice.

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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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. This ensures that your child receives the appropriate care as quickly as possible. Always be vigilant about storing medications safely to prevent any accidental ingestion.

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, it’s important to consult with a healthcare provider before starting the medication. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while using this medication.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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

The medication is applied topically, meaning it is used on the skin. It's important to keep this product out of reach of children. If swallowed, you should seek medical help or contact a poison control center immediately. Additionally, do not use this medication if you are allergic to aspirin.

FAQ

What is this product used for?

This product is an exfoliating gel that aids in reducing acne breakouts.

How should I apply the gel?

Apply a small amount with your fingers to clean, dry skin. You may use it all over the affected area or spot treat blemishes.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use it on broken skin, avoid contact with eyes, and keep it out of reach of children.

What should I do if I experience discomfort?

If any discomfort occurs, reduce the frequency of use or discontinue use altogether.

Can I use this product if I am allergic to aspirin?

No, do not use this product if you are allergic to aspirin.

Is this product safe to use during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy.

What should I do if the gel gets into my eyes?

If contact occurs, rinse thoroughly with water.

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 Spot Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Spot Treatment.
Details

Drug Information (PDF)

This file contains official product information for Acne Spot Treatment, 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 vulgaris. It is an exfoliating gel that aids in reducing acne breakouts.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to apply a small amount of the product with fingers to clean, dry skin. The formulation may be utilized over the entire affected area or specifically for spot treatment of blemishes. In cases where discomfort is experienced, it is recommended to reduce the frequency of application or discontinue use altogether.

Contraindications

Use is contraindicated in patients with a known allergy to aspirin.

Warnings and Precautions

For external use only. This product must not be applied to broken skin. Care should be taken to avoid contact with the eyes; in the event of contact, the affected area should be rinsed thoroughly with water.

It is imperative to keep this product out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or a poison control center should be contacted without delay.

This product is contraindicated in individuals with a known allergy to aspirin. Healthcare professionals should ensure that patients are screened for this allergy prior to use to prevent adverse reactions.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is intended for external use only and should not be applied to broken skin. Care should be taken to avoid contact with the eyes; in the event of contact, it is imperative to rinse thoroughly with water. These precautions are essential to minimize the risk of adverse reactions and ensure safe usage.

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 Spot Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Spot Treatment.
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 a poison control center should be contacted without delay.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The safety of salicylic acid during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when considering the administration of salicylic acid to pregnant patients.

Due to the lack of available safety data, it is recommended that women of childbearing potential discuss their treatment options with their healthcare provider to weigh the potential risks and benefits. Further studies may be necessary to elucidate any potential fetal impacts associated with the use of salicylic acid during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions provided for individuals with compromised liver function. It is recommended that healthcare professionals 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 outlined in the available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the relevant authorities to contribute to the ongoing assessment of the medication's safety profile.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. Instruct patients that if the medication is swallowed, they should seek medical help or contact a poison control center immediately.

Additionally, it is important to inform patients not to use the medication if they have a known allergy to aspirin. This precaution is essential to prevent potential allergic reactions and ensure patient safety.

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 product is administered topically. Clinicians should advise patients to keep the medication out of reach of children and to seek medical assistance or contact a poison control center immediately if swallowed. Additionally, patients should be cautioned against using the product if they have a known allergy to aspirin.

Drug Information (PDF)

This file contains official product information for Acne Spot 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 Acne Spot 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.

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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.