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Salicylic acid

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This product has been discontinued

Active ingredient
Salicylic Acid 2 g/100 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
March 21, 2024
Active ingredient
Salicylic Acid 2 g/100 g
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
March 21, 2024
Manufacturer
Tula Life LLC
Registration number
M006
NDC root
72296-020

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Drug Overview

If you're looking for a solution to manage acne, this medication is designed to help treat this common skin condition. It works by not only addressing existing acne but also by helping to prevent the development of new acne blemishes. This can be particularly beneficial for those who struggle with frequent breakouts and are seeking a way to maintain clearer skin.

Uses

If you're struggling with acne, this medication can help treat your existing breakouts and also work to prevent new blemishes from forming. By addressing both current and future acne, it aims to give you clearer skin and boost your confidence.

Dosage and Administration

Before using this product, make sure to clean the skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire affected area. You can do this one to three times a day, depending on your needs or your doctor's advice.

It's best to start with one application each day. If you find that you need more frequent use, you can gradually increase to two or three times daily. However, if you experience bothersome dryness or peeling, consider reducing your application to once a day or even every other day to help your skin adjust.

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 remember that it is for external use only. You should avoid using other topical medications at the same time, as this can lead to increased dryness or irritation of your skin. If you experience any irritation, it's best to stop using the product and consult your doctor.

Additionally, be cautious to keep the product away from your eyes. If it does come into contact with your eyes, rinse them thoroughly with water to prevent discomfort.

Warnings and Precautions

This product is intended for external use only. Be cautious if you are using other topical medications at the same time, as this may lead to increased dryness or irritation of your skin. If you experience these effects, it’s best to use only one medication unless your doctor advises otherwise.

While using this product, make sure to avoid contact with your eyes. If it does come into contact with your eyes, rinse them thoroughly with water. Always keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with products containing salicylic acid, as they have not been specifically evaluated for safety during pregnancy. This ingredient may pose potential risks to your developing baby, so it's best to consult your healthcare provider before using any such products.

In general, it is recommended to avoid salicylic acid during pregnancy unless your healthcare professional advises otherwise. Always prioritize your health and the health of your baby by discussing any concerns or questions with your doctor.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the provided information about TULA Breakout Star Oil-Free Acne Moisturizer does not include any specific guidance or warnings related to nursing mothers or lactation. This means that there are no known risks or effects on breast milk or your nursing infant mentioned in the drug insert.

As always, if you have concerns about using any skincare products while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

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. 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 about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney issues, 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 standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

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 or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

Drug Interactions

It's important to be cautious when using this product alongside other topical medications. Using multiple topical treatments at the same time or right after each other can lead to increased dryness or irritation of your skin. If you notice these side effects, it's best to limit yourself to one medication unless your healthcare provider advises otherwise.

Always discuss any medications or treatments you are using with your healthcare provider. They can help you understand the best way to use your medications safely and effectively, ensuring you get the most benefit while minimizing any potential side effects.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when you're not using it to maintain its integrity. Once opened, please remember to discard the product, as it is no longer safe to use. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

This medication is intended for external use only and should be applied topically. When using this product, be cautious about combining it with other topical medications, as this may lead to increased dryness or irritation of the skin. If you experience such effects, it’s best to use only one medication unless your doctor advises otherwise.

Make sure to avoid contact with your eyes; if this happens, rinse your eyes thoroughly with water. Keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this product?

This product is used to treat acne and helps prevent the development of new acne blemishes.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily. Start with one application daily and gradually increase 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?

This product is for external use only. Avoid contact with the eyes, and if contact occurs, rinse thoroughly with water.

What precautions should I take when using this product?

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

Can I use other topical medications at the same time?

Using other topical medications at the same time may increase dryness or irritation. If this occurs, only one medication should be used unless directed by a doctor.

Is this product safe to use during pregnancy?

The product has not been specifically evaluated for use during pregnancy. It is recommended to avoid products containing salicylic acid unless directed by a healthcare professional.

How should I store this product?

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

Packaging Info

Below are the non-prescription pack sizes of Tula Breakout Star Oil-Free Acne Moisturizer. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tula Breakout Star Oil-Free Acne Moisturizer.
Details

Description

The product is identified by the SPL code 34089-3. No additional relevant information is available regarding its characteristics or specifications.

Uses and Indications

This drug is indicated for the treatment of acne. It aids in the prevention of the development of new acne blemishes.

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.

Initial treatment should begin with one application per day. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two or three times daily.

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

Contraindications

Use 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 avoid concurrent use of other topical medications, as this may exacerbate skin dryness or irritation. In such cases, it is recommended that only one medication be applied unless otherwise directed by a healthcare provider.

When utilizing this product, it is crucial to avoid contact with the eyes. Should accidental contact occur, the affected area must be rinsed thoroughly with water to mitigate any potential irritation.

Additionally, this product should be stored out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. The concurrent use of other topical medications may lead to increased dryness or irritation of the skin. In such cases, it is advised that only one medication be used unless directed otherwise by a healthcare professional.

During the use of this product, it is crucial to avoid contact with the eyes. Should contact occur, patients are instructed to rinse the affected area thoroughly with water to mitigate any potential adverse effects.

Drug Interactions

Concurrent use of other topical medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advisable to limit the use to one topical medication at a time unless otherwise directed by a healthcare professional. Monitoring for signs of skin irritation is recommended to ensure patient safety and comfort.

Packaging & NDC

Below are the non-prescription pack sizes of Tula Breakout Star Oil-Free Acne Moisturizer. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Tula Breakout Star Oil-Free Acne Moisturizer.
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

The product has not been specifically evaluated for use during pregnancy. Salicylic acid, the active ingredient, is generally advised to be used with caution during this period due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before using this product. It is recommended to avoid the use of products containing salicylic acid during pregnancy unless directed by a healthcare professional.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for TULA Breakout Star Oil-Free Acne Moisturizer. Therefore, the effects on breastfed infants and the excretion of the product in breast milk are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on 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 information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the container from light exposure to maintain product integrity. The container should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients to avoid using other topical medications concurrently or immediately after application, as this may lead to increased dryness or skin irritation; if such reactions occur, patients should use only one medication unless directed otherwise by a healthcare professional.

Patients should also be cautioned to avoid contact with the eyes, and in the event of contact, they should rinse thoroughly with water. Additionally, it is important to keep the product out of reach of children, and if ingested, medical assistance should be sought or a Poison Control Center contacted immediately.

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 Tula Breakout Star Oil-Free Acne Moisturizer, 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.