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Dont Be Shy Acne

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This product has been discontinued

Active ingredient
Salicylic Acid 0.005 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
February 16, 2024
Active ingredient
Salicylic Acid 0.005 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
February 16, 2024
Manufacturer
Youngwon Costech Co. , ltd.
Registration number
M006
NDC root
72169-540

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Drug Overview

This medication is used for the treatment of acne, a common skin condition that can cause pimples, blackheads, and other blemishes. It helps to reduce the severity of acne and improve the overall appearance of your skin. If you're struggling with acne, this treatment may be a helpful option to consider in your skincare routine.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating and affect your confidence, but this treatment aims to reduce breakouts and improve the overall appearance of your skin.

It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause birth defects. If you have any questions or concerns about using this treatment, be sure to discuss them with your healthcare provider.

Dosage and Administration

Before using the acne patch, make sure to cleanse and dry the area where you want to apply it. Choose the right size patch for your needs, and avoid putting any skin care products on that area beforehand. Once you're ready, place the patch on the affected spot and press down firmly for about 5 seconds to ensure it sticks well.

You should leave the patch on for 7 to 10 hours. If the whitehead is still present after that time, you can apply a new patch as needed, depending on the size and stage of the acne. If you're considering using this product for a child under 12 years old, it's best to consult a health professional first.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or risks of abuse, misuse, or dependence associated with it, you should take care to avoid swallowing the medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center for assistance. Your safety is a priority, so please follow these guidelines closely.

Side Effects

Using this medication may lead to skin irritation and dryness, especially if you are also using another topical acne product. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time. Additionally, if you have a known allergy to the dressing or any of its components, you should avoid using it altogether.

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

Warnings and Precautions

This product is for external use only and is flammable, so be sure to keep it away from heat or flames. If you are using another topical acne treatment, be cautious, as this can increase the risk of skin irritation and dryness. It’s best to use only one topical acne medication at a time to minimize these effects.

Do not use this product if you are allergic to the dressing or any of its ingredients. Always keep it out of reach of children. If the product is swallowed, seek medical help immediately or contact a Poison Control Center.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can contact a Poison Control Center for guidance on what to do next. Signs of an overdose can vary, but they may include unusual symptoms or changes in behavior.

Always take overdosing seriously. If you suspect an overdose, don’t wait for symptoms to appear—reach out for help right away. Your safety is the top priority, so getting professional advice is crucial.

Pregnancy Use

It’s important to know that this product has not been evaluated for safety during pregnancy, which means there is limited information about how it may affect you or your developing baby. While there are no specific contraindications listed, caution is advised since the effects on a fetus are unknown.

Currently, there are no details regarding potential risks to the fetus, and no dosage modifications or special precautions have been provided for pregnant individuals. If you are pregnant or planning to become pregnant, it’s best to discuss any concerns with your healthcare provider to ensure the safest choices for you and your baby.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult a healthcare professional first. They can provide guidance on whether this medication is appropriate for your child and what the correct dosage should be. Always prioritize your child's safety by seeking expert advice before administering any medication.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be cautious when using multiple acne treatments at the same time. If you use another topical acne product along with this medication, you may experience increased skin irritation and dryness. To minimize these side effects, it's best to use only one topical acne medication at a time.

While there are no specific interactions with laboratory tests or other medications mentioned, it's always a good idea to discuss any treatments or tests with your healthcare provider. They can help ensure that your treatment plan is safe and effective for you.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from extreme temperatures and direct sunlight. Avoid areas that may be too hot or too cold, as these conditions can affect the product's effectiveness.

When you're ready to use the product, make sure to take it out of its packaging and use it right away. This helps maintain its quality and ensures that you get the best results. Always handle the product with care to avoid any damage.

Additional Information

No further information is available.

FAQ

What is this drug used for?

This drug is used for the treatment of acne.

How should I use the acne patch?

Cleanse and dry the affected area, select the appropriate patch size, and apply it to the area. Press down for 5 seconds and leave it on for 7 to 10 hours.

Can children use this product?

Children 12 years and younger should ask a health professional before use.

What should I do if I swallow the product?

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

Are there any warnings I should be aware of?

Yes, skin irritation and dryness may occur if used with other topical acne products. Do not use if allergic to any components.

Is this product safe to use during pregnancy?

The product has not been evaluated for safety in pregnancy, and caution is advised as effects on a developing fetus are unknown.

What about nursing mothers?

Nursing mothers should consult a healthcare professional before use, as there is potential for excretion in breast milk.

How should I store this product?

Store the product in a suitable environment, avoiding high or low temperatures and direct sunlight.

Packaging Info

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

Packaging configurations for Dont Be Shy Acne.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the treatment of acne. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children over 12 years of age should cleanse and dry the affected area prior to application of the patch. The appropriate size of the patch must be selected based on the size and stage of the acne lesion. It is important to avoid applying any skin care products to the desired area before patch application. The patch should be applied directly to the affected area, ensuring it is pressed down firmly for 5 seconds to secure adherence.

The patch should remain in place for a duration of 7 to 10 hours. If necessary, a new patch may be applied, particularly if the size and stage of the whitehead warrant additional treatment.

For children 12 years and younger, it is recommended to consult a healthcare professional for guidance on appropriate use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately or contact a Poison Control Center for further guidance.

Warnings and Precautions

For external use only; this product is flammable and should be kept away from heat or flame.

Caution is advised regarding the potential for skin irritation and dryness, particularly when used concurrently with other topical acne treatments. To minimize the risk of irritation, it is recommended that only one topical acne medication be used at a time.

This product should not be used by individuals with known allergies to the dressing or any of its components.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if they concurrently use another topical acne product. It is advised that only one topical acne medication be used at a time to minimize the risk of irritation.

Additionally, patients should not use this product if they have a known allergy to the dressing or any of its components. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

Skin irritation and dryness may be exacerbated when another topical acne product is used concurrently. It is advisable to limit the use of topical acne medications to one at a time to minimize the risk of irritation.

No specific drug or laboratory test interactions have been identified in the available data.

Packaging & NDC

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

Packaging configurations for Dont Be Shy Acne.
Details

Pediatric Use

Pediatric patients 12 years of age and younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Pregnancy

The product has not been evaluated for safety in pregnancy, and caution is advised as the effects on a developing fetus are unknown. There is no specific information available regarding risks to the fetus. Additionally, no dosage modifications are recommended for pregnant individuals, and no special precautions have been outlined for use during pregnancy. Healthcare professionals should consider these factors when prescribing this product to pregnant patients or women of childbearing potential.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk. The effects on a nursing infant are not well studied; therefore, caution is advised.

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 seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center or seek medical help without delay if the substance has been ingested.

Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Healthcare providers should monitor for any adverse effects and provide supportive care as necessary.

Management of overdosage should include symptomatic treatment and may require specific interventions based on the clinical presentation. Continuous monitoring of vital signs and supportive measures are recommended until the patient is stabilized.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This information is vital for ensuring patient safety and prompt intervention if necessary.

Storage and Handling

This product is supplied in a configuration that ensures optimal quality and efficacy. It is essential to store the product in a controlled environment, avoiding exposure to inappropriate conditions such as extreme temperatures or direct sunlight.

For best results, the product should be used immediately after removal from its packaging. Proper handling and adherence to these storage guidelines are crucial to maintain the integrity of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Dont Be Shy Acne, 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 Dont Be Shy Acne, 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.