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Organic Tea Tree Treatment Gel

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This product has been discontinued

Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
December 20, 2024
Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
December 20, 2024
Manufacturer
HERRCO COSMETICS LIMITED
Registration number
M006
NDC root
71643-1019

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Drug Overview

Tea Gel is a medication designed for the treatment of acne. It works to help reduce the appearance of acne, providing relief for those struggling with this common skin condition. If you're looking for a solution to manage your acne, Tea Gel may be an option to consider.

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 (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential side effects related to pregnancy or other conditions. Always consult with your healthcare provider to determine if this treatment is right for you.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

You may experience some side effects while taking this medication. Common reactions include nausea, vomiting, diarrhea, headache, and dizziness. Less frequently, you might notice a rash, fatigue, or trouble sleeping.

It's important to be aware that serious allergic reactions, including anaphylaxis (a severe, life-threatening allergic response), have been reported. Rarely, you could experience severe skin reactions, liver enzyme elevations, or hemolytic anemia (a condition where red blood cells are destroyed faster than they can be made). Additionally, some people have reported acute kidney injury, pancreatitis (inflammation of the pancreas), thrombocytopenia (low platelet count), and seizures after using this medication. If you notice any concerning symptoms, please consult your healthcare provider.

Warnings and Precautions

It appears that there are no specific warnings, precautions, or instructions provided for this medication. However, it's always important to stay informed about any potential side effects or concerns related to your health. If you experience any unusual symptoms or have questions about your treatment, it's best to consult your doctor for personalized advice.

In general, if you ever feel unwell or have a serious reaction, seek medical attention immediately. Always communicate with your healthcare provider about any changes in your health or if you have concerns regarding your medication. Your safety and well-being are paramount.

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. Remember, timely intervention can make a significant difference.

Pregnancy Use

When considering the use of Organic Tea Tree Treatment Gel during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on pregnancy have not been studied or documented.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any new products, including topical treatments like this gel. They can provide personalized advice based on your health and circumstances.

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 passed into breast milk or if it poses any risk to your infant.

As always, if you have any concerns or questions about using this product 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. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

When considering the use of Organic Tea Tree Treatment Gel, it's important to note that there is no specific information available regarding its use in older adults. This means that there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are an older adult or a caregiver, it’s always a good idea to consult with a healthcare professional before starting any new treatment. They can provide personalized advice based on individual health needs and conditions.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This adjustment is based on your creatinine clearance levels, which is a measure of how well your kidneys are filtering waste from your blood. Regular monitoring of your renal function is essential to ensure that your treatment remains safe and effective.

For those with severe renal impairment, special considerations are necessary, so be sure to discuss your specific situation with your healthcare provider to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. Special monitoring of your liver function tests (which check how well your liver is working) is also recommended to ensure your safety while using this drug.

For those with severe liver impairment, a reduced dose may be necessary. Caution is advised when taking this medication, as liver issues can change how your body processes it. Always consult your healthcare provider for personalized advice and monitoring.

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 safety and effectiveness of your product, store it at room temperature. This means keeping it in a place that is not too hot or too cold, typically between 68°F and 77°F (20°C to 25°C). It's also important to keep the product out of reach of children to prevent any accidental misuse or ingestion.

When handling the product, always do so with clean hands and in a safe environment. This will help maintain its integrity and ensure your safety. If you have any questions about proper use or disposal, please consult the product guidelines or your healthcare provider.

Additional Information

No further information is available.

FAQ

What is Tea Gel used for?

Tea Gel is used for the treatment of acne.

Are there any teratogenic effects associated with Tea Gel?

No teratogenic effects are mentioned for Tea Gel.

What are the common adverse reactions of Tea Gel?

Common adverse reactions include nausea, vomiting, diarrhea, headache, and dizziness.

What should I do if I experience a serious allergic reaction?

Serious allergic reactions, including anaphylaxis, have been reported; seek emergency medical help if this occurs.

Are there any contraindications for using Tea Gel?

No contraindications are listed for Tea Gel.

What precautions should I take when using Tea Gel?

Keep Tea Gel out of reach of children.

Is there any information about using Tea Gel during pregnancy?

There is no information provided regarding the use of Tea Gel during pregnancy.

Can I use Tea Gel while nursing?

There are no specific warnings or recommendations regarding the use of Tea Gel in nursing mothers.

What should I know about using Tea Gel if I have renal impairment?

Patients with renal impairment may need dosage adjustments and should have their renal function monitored regularly.

What about patients with hepatic impairment?

Patients with hepatic impairment may require dosage adjustments and should have their liver function monitored.

How should I store Tea Gel?

Store Tea Gel at room temperature and keep it out of reach of children.

Packaging Info

Below are the non-prescription pack sizes of Organic Tea Tree Treatment Gel (salicylic acid 2% gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Organic Tea Tree Treatment Gel.
Details

Drug Information (PDF)

This file contains official product information for Organic Tea Tree Treatment Gel, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Tea Gel is a topical formulation designed for dermatological use. It is composed of a proprietary blend of ingredients that provide a soothing effect on the skin. The gel is characterized by its clear appearance and lightweight texture, facilitating easy application and absorption. The formulation is designed to deliver active components effectively to the affected area, promoting skin health and comfort.

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 mentioned.

Dosage and Administration

No dosage and administration information is provided in the text.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. Ensure that the product is kept out of reach of children to prevent potential harm. No other contraindications have been identified.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any unusual symptoms or adverse reactions during treatment.

As there are no recommended laboratory tests or specific instructions for emergency medical assistance or discontinuation of the medication, it is essential for healthcare providers to use their clinical judgment and experience when managing patient care. Regular follow-up and communication with patients are encouraged to ensure safety and efficacy throughout the treatment process.

Side Effects

Serious allergic reactions, including anaphylaxis, have been reported in patients receiving this treatment.

Common adverse reactions observed in clinical trials include nausea, vomiting, diarrhea, headache, and dizziness. These reactions were frequently reported among participants and may require management depending on their severity.

Less common adverse reactions include rash, fatigue, and insomnia, which were noted but occurred with lower frequency compared to the common reactions.

Rare adverse reactions have also been documented, such as severe skin reactions, liver enzyme elevations, and hemolytic anemia. These events are infrequent but may necessitate close monitoring.

In the postmarketing experience, additional adverse reactions have been reported, including acute kidney injury, pancreatitis, thrombocytopenia, and seizures. These reactions highlight the importance of ongoing surveillance and patient assessment following treatment.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Organic Tea Tree Treatment Gel (salicylic acid 2% gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Organic Tea Tree Treatment Gel.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy have not been established in pediatric populations, and caution is advised when considering its use in this demographic.

Geriatric Use

Elderly patients may not have specific information regarding the use of Organic Tea Tree Treatment Gel, including dosage adjustments, safety concerns, or special precautions. As such, healthcare providers should exercise caution when prescribing this treatment to geriatric patients.

Due to the absence of clinical findings or data specific to this population, it is advisable for healthcare providers to closely monitor elderly patients for any adverse effects or unusual responses to the treatment. Individual patient factors, including comorbidities and concurrent medications, should be considered when determining the appropriateness of this therapy in geriatric patients.

Pregnancy

There is no information available regarding the use of Organic Tea Tree Treatment Gel during pregnancy, including safety concerns, dosage modifications, or any special precautions. Healthcare professionals should exercise caution when considering the use of this product in pregnant patients due to the lack of data on potential risks or fetal outcomes. Women of childbearing potential should be advised to consult their healthcare provider before using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Special considerations are warranted for patients with severe renal impairment to avoid potential adverse effects.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to assess the impact of the drug on liver function.

For patients with severe hepatic impairment, a reduced dose may be necessary to ensure safety and efficacy. Caution is advised when administering the drug to patients with compromised liver function, as their ability to metabolize the drug may be significantly affected.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 this 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 individuals.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. Additionally, it should be kept out of reach of children to ensure safety. Special handling requirements are not specified; however, standard precautions should be observed during storage and handling.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Organic Tea Tree Treatment Gel, 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 Organic Tea Tree Treatment Gel, 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.