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Blemish Spot Treatment

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Active ingredient
Salicylic Acid 0.01 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
December 29, 2025
Active ingredient
Salicylic Acid 0.01 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
December 29, 2025
Manufacturer
Skin Script, LLC
Registration number
M006
NDC root
83657-472

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

Drug Overview

This medication is used for the treatment of acne, helping to dry and clear acne blemishes while allowing your skin to heal. It works by penetrating the pores to reduce the number of existing acne blemishes, blackheads, and whiteheads, and it also helps prevent the development of new ones.

By targeting the root causes of acne, this treatment aims to improve your skin's overall appearance and health. If you're struggling with acne, this medication may be a helpful option to consider for clearer skin.

Uses

If you're dealing with acne, this treatment can be a helpful option for you. It works by drying and clearing up acne blemishes, allowing your skin to heal effectively.

The formula penetrates deep into your pores to reduce the number of existing acne blemishes, blackheads, and whiteheads. Additionally, it helps prevent the formation of new blemishes, ensuring your skin stays clearer for longer.

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 need more treatment, you can gradually increase the application to two or three times daily, but only if directed by a skin care professional.

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 your skin while still getting the benefits of the product.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

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 the risk of irritation, it’s best to use only one topical acne treatment at a time. If you notice a rash, stop using the product and consult a doctor.

This product is for external use only, so be sure to keep it out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only. If you are using another topical acne medication at the same time, you may experience more skin irritation and dryness. To avoid this, it’s best to use only one topical acne treatment at a time.

If you notice a rash while using this product, stop using it immediately and contact your doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center right away.

Overdose

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.

In case of an overdose, you may notice symptoms such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these signs, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with the use of salicylic acid. The safety of this ingredient during pregnancy has not been established, and it is generally advised against due to potential risks to your developing baby. There may be a risk of teratogenic effects, which means it could potentially cause developmental issues in the fetus.

To ensure your safety and that of your baby, you should avoid using products containing salicylic acid unless specifically directed by a healthcare provider. Always consult with your healthcare professional before using any new products during pregnancy to discuss any potential risks and receive personalized 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 using medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and ensure that the treatment is safe and appropriate based on individual health needs.

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 tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. 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. To avoid excessive skin dryness, start with one application daily. If your skin tolerates it well, you can gradually increase to two or three times daily, or follow the advice of your skin care professional. 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, helping to dry and clear acne blemishes while allowing the skin to heal.

How does this product work?

It penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads, and helps prevent the development of new ones.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily, starting with one application daily and increasing as needed.

What should I do if I experience dryness or peeling?

If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Skin irritation and dryness may occur if used with other topical acne medications. Stop use and consult a doctor if a rash occurs.

Is this product safe to use during pregnancy?

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

What should I do if I swallow this product?

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

How should I store this product?

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

Packaging Info

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

Packaging configurations for Blemish Spot Treatment.
Details

Drug Information (PDF)

This file contains official product information for Blemish 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. It effectively dries and clears acne blemishes, facilitating the healing process of the skin. The formulation penetrates pores to reduce the number of acne blemishes, blackheads, and whiteheads. Additionally, it helps prevent the development of new acne blemishes, blackheads, and whiteheads.

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.

It is recommended to initiate treatment with one application per day. Based on the patient's response and as directed by a skin care professional, the frequency may be gradually increased to two or three times daily.

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

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. The application of this product may lead to increased skin irritation and dryness, particularly if used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised to use only one topical acne treatment at a time.

In the event of a rash, it is imperative to discontinue use and consult a healthcare professional. Additionally, this product should be kept out of reach of children. If ingested, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should be vigilant in monitoring patients for signs of adverse reactions, particularly skin irritation. If any concerning symptoms arise, it is essential to advise patients to stop using the product and seek medical advice promptly.

Side Effects

Patients using this product should be aware that it is intended for external use only. The concurrent use of this product with other topical acne medications may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is advised that patients limit their use to one topical acne medication at a time.

Serious adverse reactions may include the development of a rash. Patients are instructed to discontinue use and consult a healthcare professional if such a reaction occurs.

Additionally, this product should be kept out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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

Packaging configurations for Blemish 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

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 therapeutic response, given the lack of targeted data for 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 may be a risk of teratogenic effects associated with the use of salicylic acid during this period. Pregnant women should avoid the use of this product unless directed by a healthcare provider. It is essential for women of childbearing potential to consult a healthcare professional before using this product if they are pregnant or planning to become pregnant.

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 from the use of this product during 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, it is imperative to keep the medication out of reach of children to prevent accidental ingestion. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay for further guidance.

Prompt action is crucial in managing potential overdosage situations to mitigate risks and ensure patient safety.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

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 protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

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. To minimize the risk of excessive skin drying, it is advised to begin with one application per day, gradually increasing to two or three times daily as necessary or as directed by a skin care professional. Should patients experience bothersome dryness or peeling, they 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 Blemish 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 Blemish 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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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.