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Spot on Acne Patch

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This product has been discontinued

Active ingredient
Salicylic Acid 1.24 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
June 18, 2024
Active ingredient
Salicylic Acid 1.24 g
Other brand names
Dosage form
Patch
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
June 18, 2024
Manufacturer
ACNEFREE, LLC
Registration number
M006
NDC root
80861-111

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Drug Overview

Spot On Acne Patch is a treatment specifically designed to help manage acne. It works by applying a patch directly to the affected area, targeting blemishes to promote healing and reduce inflammation. This product is intended for individuals looking for a convenient and effective way to address acne breakouts.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating, but with the right treatment, you can see improvements in your skin's appearance and health.

It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause birth defects. Additionally, there are no reported nonteratogenic effects, which means it doesn't have harmful effects that aren't related to birth defects either. Always consult with your healthcare provider for personalized advice and to ensure this treatment is right for you.

Dosage and Administration

To use the patch effectively, start by cleansing your face and making sure it is completely dry. Once your skin is prepared, take the patch out of its packaging and apply it directly onto the blemish you want to treat.

For the best results, keep the patch on for at least 6 hours. Remember, it's most effective when used within 10 days after you open the package, so try to use it soon after opening to ensure you get the maximum benefit.

What to Avoid

It’s important to prioritize your safety when using this patch. You should not use it if you are allergic to the patch or any of its components, as this could lead to serious reactions.

Additionally, be aware that this patch is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using the patch in any way that is not prescribed.

Side Effects

When using this patch, it's important to remember that it is for external use only. If you have a known allergy to the patch or any of its ingredients, you should not use it.

If you experience any skin irritation while using the patch, please stop using it and consult your doctor for further advice. Your safety and comfort are important, so don't hesitate to seek help if needed.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. If you have a known allergy to the patch or any of its ingredients, do not use it.

In case of accidental swallowing, seek medical assistance immediately or contact a Poison Control Center. If you experience any skin irritation while using the patch, stop using it and consult your doctor for further advice.

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 aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it may be wise to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby's well-being.

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.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances.

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 and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they may need to adjust your medications or monitor you more closely.

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 (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best results, use the product within 10 days after opening. This timeframe helps maintain its effectiveness and safety.

When handling the product, always follow proper hygiene practices to avoid contamination. Make sure to store it in a cool, dry place, away from direct sunlight, to preserve its quality. If you have any questions about disposal or specific handling instructions, please refer to the guidelines provided with the product.

Additional Information

No further information is available.

FAQ

What is Spot On Acne Patch used for?

Spot On Acne Patch is used for the treatment of acne.

How should I use the Spot On Acne Patch?

Cleanse and thoroughly dry your face, then remove the patch and apply it directly onto the blemish. Leave the patch on for at least 6 hours.

Are there any contraindications for using Spot On Acne Patch?

Do not use Spot On Acne Patch if you are allergic to the patch or any of its components.

What should I do if I experience skin irritation?

Stop use and ask a doctor if skin irritation occurs.

Is Spot On Acne Patch safe to use during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

Can nursing mothers use Spot On Acne Patch?

No specific information is provided regarding the use of Spot On Acne Patch by nursing mothers.

What should I do if the patch is swallowed?

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

How long is Spot On Acne Patch effective after opening?

It is best used within 10 days after opening.

Are there any known drug interactions with Spot On Acne Patch?

No specific drug interactions are mentioned.

Is Spot On Acne Patch for external use only?

Yes, Spot On Acne Patch is for external use only.

Packaging Info

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

Packaging configurations for Spot on Acne Patch.
Details

Drug Information (PDF)

This file contains official product information for Spot on Acne Patch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The Spot On Acne Patch is presented in an image/jpeg format, with a reference value of SpotOn_NDC80861-111-01.jpg. The effective time for this product is noted as April 10, 2023.

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to cleanse and thoroughly dry the affected area of the face prior to application. The patch should be removed from its packaging and applied directly onto the blemish. It is recommended that the patch remains in place for a minimum duration of 6 hours to ensure optimal efficacy. For best results, the patch should be used within 10 days of opening.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to the patch or any of its components.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid using the product if they have a known allergy to the patch or any of its components. In the event of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Center.

Patients should be monitored for any signs of skin irritation. If such irritation occurs, it is essential to discontinue use and consult a healthcare provider for further evaluation and management.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated in individuals who have a known allergy to the patch or any of its components.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if any skin irritation occurs. This precaution is essential to ensure the safety and well-being of the patient while using the product.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Spot on Acne Patch.
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 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly, and alternative treatment options may need to be considered in the context of pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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 relation to 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 prescribing information.

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 and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the patch is swallowed. It is crucial to inform patients not to use the patch if they have a known allergy to it or any of its components, as this could lead to serious adverse reactions.

Additionally, healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any skin irritation while using the patch. This precaution helps ensure patient safety and promotes appropriate management of any potential side effects.

Storage and Handling

The product is best utilized within 10 days following its opening to ensure optimal efficacy and safety. It is essential to adhere to this timeframe for proper usage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Spot on Acne Patch, 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 Spot on Acne Patch, 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.