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Acne Gel Pen

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Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 18, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 20 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
October 18, 2025
Manufacturer
Tiege Hanley
Registration number
M006
NDC root
71714-004
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Tiege Hanley Acne Gel Pen is a topical treatment designed for the management of acne. This gel pen provides a convenient way to apply medication directly to affected areas, helping to reduce breakouts and improve the overall appearance of your skin. If you're struggling with acne, this product may be a helpful addition to your skincare routine.

Uses

If you're dealing with acne, this medication can help you manage your condition effectively. It is specifically designed to treat acne, helping to reduce breakouts and improve the overall appearance of your skin.

You can feel reassured that there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

To use this medication effectively, start by cleaning your skin thoroughly. Once your skin is clean, twist the bottom of the pen to release the liquid. You can then apply the liquid directly onto individual blemishes or clusters. It’s important to cover the entire affected area with a thin layer.

Initially, you should apply the medication 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 your doctor. If you experience bothersome dryness or peeling, it’s best to reduce your application to once a day or even every other day to avoid irritation.

What to Avoid

It's important to be aware of certain precautions when using this product. You should never swallow it; if you do, seek medical help or contact a Poison Control Center immediately. Additionally, if you experience severe irritation while using the product, stop using it and consult your doctor.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse or dependence associated with this product. However, always prioritize your safety and well-being by following these guidelines.

Side Effects

You may experience some skin irritation or dryness when using this medication, especially if you are also using other topical acne treatments. It's important to avoid this product if you have very sensitive skin or if you are allergic to salicylic acid. If you notice severe irritation, stop using the product and consult a doctor.

In case of accidental ingestion, seek medical assistance immediately or contact a Poison Control Center for help.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may be sensitive. If you are using other topical acne treatments, be cautious, as combining them can increase the risk of skin irritation and dryness. If you experience severe irritation, stop using the product and consult your doctor.

Keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center. Additionally, remember that this product is flammable, so keep it away from high heat and flames.

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 emergency assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, 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 starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the safety of this product during lactation (the period of breastfeeding) has not been established. There is a possibility that the product may be excreted in breast milk, which means it could potentially affect your baby. Therefore, you should exercise caution when considering the use of this product while nursing. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices for you and your baby.

Pediatric Use

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. You should also stop using the medication and consult a doctor if your child experiences severe irritation.

Additionally, avoid using this product on children who have very sensitive skin or are known to be sensitive to salicylic acid (a common ingredient in some medications). Always prioritize your child's safety and well-being when using any medication.

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 for personalized advice. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 recommendations apply, and there are no special monitoring requirements or precautions outlined for patients like you.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your liver health. They can provide guidance based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share any concerns you may have regarding your medications or health tests.

Storage and Handling

To ensure your safety while using this product, it's important to store it properly. Keep it away from high heat and flames, as it is flammable. This means you should avoid placing it near stoves, heaters, or any open flames to prevent any fire hazards.

When handling the product, always do so with care to maintain safety. Make sure to follow any additional guidelines provided with the product for safe usage and disposal. By taking these precautions, you can help ensure a safe experience.

Additional Information

You should apply this medication topically, covering the entire affected area with a thin layer one to three times a day. If you experience severe irritation, stop using the product and consult your doctor. Be cautious if you are using other topical acne treatments at the same time, as this can increase the likelihood of skin irritation and dryness. It's best to use only one topical acne medication at a time. Additionally, avoid using this product if you have very sensitive skin or are allergic to salicylic acid.

FAQ

What is the Tiege Hanley Acne Gel Pen used for?

The Tiege Hanley Acne Gel Pen is used for the management of acne.

How should I apply the Tiege Hanley Acne Gel Pen?

Twist the bottom of the pen to release the liquid and apply it directly on individual blemishes or clusters. Clean the skin thoroughly before application.

How often can I use the acne gel pen?

You can cover the affected area with a thin layer one to three times daily, starting with one application daily and gradually increasing as needed.

What should I do if I experience dryness or irritation?

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

Are there any contraindications for using this product?

There are no contraindications listed for the Tiege Hanley Acne Gel Pen.

What precautions should I take when using this product?

Do not use if you have very sensitive skin or are sensitive to salicylic acid. Stop use and ask a doctor if irritation becomes severe.

What should I do if I accidentally swallow the product?

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

Is this product safe to use during pregnancy or while nursing?

The safety of this product during pregnancy has not been established, and caution should be exercised when administering it to nursing mothers.

What are the storage instructions for the Tiege Hanley Acne Gel Pen?

Keep the product out of reach of children and away from high heat and flame, as it is flammable.

Packaging Info

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

Packaging configurations for Acne Gel Pen.
Details

Drug Information (PDF)

This file contains official product information for Acne Gel Pen, 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 drug.

Uses and Indications

This drug is indicated for the management of acne.

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

Dosage and Administration

Healthcare professionals should instruct patients to clean the skin thoroughly prior to application of the product. The product is to be applied directly to individual blemishes or clusters.

To prepare the product for use, the patient should twist the bottom of the pen to release the liquid. A thin layer of the liquid should be applied to the entire affected area one to three times daily. It is recommended to start with one application per day, gradually increasing to two or three times daily as needed or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, the frequency of application should be reduced to once a day or every other day.

Contraindications

Use is contraindicated in patients who have ingested the product orally; immediate medical assistance or contact with a Poison Control Center is required in such cases. Additionally, if irritation becomes severe, discontinuation of use and consultation with a healthcare professional is advised.

Warnings and Precautions

For external use only, this product may cause skin irritation and dryness, particularly when used concurrently with other topical acne medications. It is advised that only one topical acne treatment be utilized at a time to minimize the risk of irritation.

Individuals with very sensitive skin or those who have demonstrated sensitivity to salicylic acid should refrain from using this product. In the event of severe irritation, it is imperative to discontinue use and consult a healthcare professional.

This product must 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.

Additionally, this product is flammable; therefore, it should be stored away from high heat and open flames to prevent fire hazards.

Side Effects

Patients may experience various adverse reactions associated with the use of this medication. Serious reactions include skin irritation, which may necessitate discontinuation of use. Participants should be advised that dryness is more likely to occur if another topical acne medication is used concurrently.

It is important to note that this medication should not be used by individuals with very sensitive skin or those who are sensitive to salicylic acid. In the event of severe irritation, patients are instructed to stop use and consult a healthcare professional.

Additionally, if the medication is swallowed, 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 this medication. Additionally, there are no known 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 Gel Pen (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Acne Gel Pen.
Details

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

Healthcare professionals should instruct caregivers to discontinue use and consult a physician if severe irritation occurs. Additionally, this product is not recommended for use in children with very sensitive skin or those who have a known sensitivity to salicylic acid.

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 elderly patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

The safety of this product during lactation has not been established. There is a potential for excretion in breast milk; therefore, caution should be exercised when administering this product to nursing mothers.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdosage, it is imperative to keep the medication out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals should advise caregivers to contact a Poison Control Center without delay.

Prompt intervention 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 text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 or contact a Poison Control Center immediately.

Additionally, patients should be informed to discontinue use and consult a doctor if they experience severe irritation. This guidance is essential to ensure patient safety and appropriate management of any adverse reactions.

Storage and Handling

The product is classified as flammable and must be stored away from high heat and open flames to ensure safety. It is essential to maintain appropriate storage conditions to prevent any risk associated with flammability.

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. Clinicians should advise patients to discontinue use and consult a doctor if severe irritation occurs. It is important to note that the likelihood of skin irritation and dryness increases when used concurrently with other topical acne medications; therefore, patients should limit the use to one topical acne treatment at a time. Additionally, the medication is contraindicated for individuals with very sensitive skin or those who are sensitive to salicylic acid.

Drug Information (PDF)

This file contains official product information for Acne Gel Pen, 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 Gel Pen, 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.

Learn more in our Editorial Policy

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.