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Acne Spot Treatment

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Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
January 12, 2026
Active ingredient
Salicylic Acid 2 g/100 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 2021
Label revision date
January 12, 2026
Manufacturer
Skinfix, Inc.
Registration number
M006
NDC root
61328-404

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Drug Overview

This medication is designed to help clear acne blemishes and promote healing of the skin. It works by keeping your skin clear of new acne blemishes and preventing them from forming in the first place. If you're struggling with acne, this treatment may be a supportive option to help improve your skin's appearance and health.

Uses

This medication is designed to help you manage acne effectively. It works by clearing existing acne blemishes and promoting the healing of your skin. Additionally, it helps keep your skin clear by preventing new acne blemishes from forming, giving you a better chance at maintaining a clearer complexion.

You can feel confident using this treatment, as there are no reported teratogenic effects (which means it does not cause birth defects) associated with it. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

To use this medication effectively, start by cleansing the area where you have blemishes or skin issues. After your skin is clean, apply the medication directly onto the affected area. You should do this 1 to 2 times each day for the best results. Consistency is key, so try to stick to this routine to help improve your skin condition.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

When using this product, it's important to note that it is for external use only. You may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. If you notice any irritation, it's advisable to stop using the other medication and use only one topical acne treatment at a time to minimize discomfort.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that are not intended. While using this medication, be aware that skin irritation and dryness may increase if you use another topical acne treatment at the same time. To minimize the risk of irritation, it’s best to use only one topical acne medication 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. Your safety is important, so please take these precautions seriously.

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, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

It is important to know that this product is not safe to use during pregnancy. Using salicylic acid while pregnant may pose potential risks to your developing baby. If you are pregnant or planning to become pregnant, it is best to avoid this product and consult with your healthcare provider for safer alternatives. Your health and the health of your baby are the top priority, so always discuss any medications or treatments with your doctor.

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 using medications while breastfeeding.

Pediatric Use

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

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the medication may not have special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can provide guidance tailored to your needs, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver 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 dosing and monitoring practices apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your liver health. Regular liver function tests (which check how well your liver is working) may also be recommended to monitor your condition. Always keep your doctor informed about your liver health when discussing treatment options.

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 performance of your product, store it at room temperature and keep it tightly closed when not in use. It's important to protect the product from light to maintain its effectiveness. Once you open the product, please remember to discard it after use to ensure safety and prevent contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the medication directly to the blemish or affected area after cleansing your skin. It's recommended to do this 1-2 times daily for the best results. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this product?

This product helps clear acne blemishes, allows skin to heal, and prevents new acne blemishes from forming.

How should I apply this product?

You should apply it directly onto the blemish or affected area after cleansing 1-2 times daily.

Are there any contraindications for using this product during pregnancy?

Yes, the product is contraindicated in pregnancy due to potential risks to the fetus associated with salicylic acid.

What should I do if the product is swallowed?

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

Is this product safe for nursing mothers?

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

What precautions should I take when using this product?

For external use only. Skin irritation and dryness are more likely if you use another topical acne medication at the same time.

How should I store this product?

Store at room temperature, keep tightly closed when not in use, and protect from light.

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 helps clear existing acne blemishes and facilitates the healing of the skin. Additionally, it aids in maintaining clear skin by preventing the formation of new acne blemishes.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

The product should be applied directly onto the blemish or affected area following cleansing. This application should occur 1 to 2 times daily, depending on the severity of the condition and the patient's response to treatment. It is essential to ensure that the skin is clean and dry before application to maximize efficacy.

Contraindications

Use of this product is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to exercise caution when using this medication, particularly in conjunction with other topical acne treatments. The concurrent use of multiple topical acne medications may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients limit their 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 cases of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is for external use only. When using this product, skin irritation and dryness are more likely to occur if another topical acne medication is used concurrently. In the event that irritation occurs, it is advised to use only one topical acne medication at a time to minimize the risk of adverse reactions.

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 contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

The product is contraindicated in pregnancy due to potential risks to the fetus associated with the use of salicylic acid. Healthcare professionals should advise pregnant patients to avoid this product, as the safety of salicylic acid during pregnancy has not been established. Women of childbearing potential should be informed of these risks and counseled on the importance of effective contraception while using this product.

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 during the use of this product.

Renal Impairment

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

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 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, altered mental status, cardiovascular instability, or gastrointestinal disturbances.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

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.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a configuration that ensures optimal use and storage. It should be stored at room temperature, away from direct light exposure. To maintain its integrity, the product must be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

Patients are advised to apply the product directly to the blemish or affected area after cleansing, with a recommended frequency of 1-2 times daily. 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 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.