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Controlling Balm with Tea Tree Oil

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This product has been discontinued

Active ingredient
Salicylic Acid 0.24 mg/29.6 mg
Other brand names
Dosage form
Emulsion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
July 2, 2025
Active ingredient
Salicylic Acid 0.24 mg/29.6 mg
Other brand names
Dosage form
Emulsion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
July 2, 2025
Manufacturer
CA-BOTANA INTERNATIONAL
Registration number
M006
NDC root
35192-016

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Drug Overview

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Uses

You may be prescribed this medication for specific health conditions. It is important to understand that this drug is used to treat certain medical issues effectively. While the details of these conditions are not provided here, knowing that this medication has specific uses can help you discuss your treatment options with your healthcare provider.

If you have any questions about how this medication can help you or if it’s the right choice for your health needs, be sure to reach out to your doctor or pharmacist for more information. They can provide you with the guidance you need to make informed decisions about your treatment.

Dosage and Administration

To use this medication effectively, start by thoroughly cleansing your skin with a gentle foam cleanser. Once your skin is clean, apply a thin layer of the medication to the entire affected area. You should begin with one application each day. If you find that your skin tolerates it well, you can gradually increase to applying it twice daily, unless your doctor advises otherwise.

It's important to pay attention to how your skin reacts. If you experience bothersome dryness or peeling, consider reducing the frequency of application to once a day or even every other day. This way, you can find the right balance that works for your skin while still benefiting from the treatment.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, it's important to remember that it is for external use only and should not be applied to wounds or damaged skin. You should follow the directions carefully, avoiding contact with your eyes and not bandaging the area too tightly.

If you notice any redness, irritation, or if your condition worsens or does not improve after 7 days, you should stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, it's advisable to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin. Use it exactly as directed, and be careful not to let it come into contact with your eyes. It's important not to wrap the area tightly after application.

If you notice any redness, irritation, or if your condition worsens or does not improve after 7 days, stop using the product and consult your doctor. Additionally, if your symptoms improve and then return within a few days, you should also reach out to your healthcare provider.

In case of accidental ingestion, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please take these precautions seriously.

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

There is currently no specific information available about the use of Controlling Balm with Tea Tree Oil during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or topical treatments you may consider during this time.

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 use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both 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 right away. 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 wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. You can find important information, such as the lot number and expiration date, printed on the crimp or the box. Be sure to check these details before use to ensure that the product is still valid and safe for your needs.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, covering the entire affected area with a thin layer once or twice daily. It's best to start with one application per day and increase to two if necessary, as directed by your doctor. If you experience dryness or peeling, reduce the frequency to once a day or every other day.

Remember, this product is for external use only. Avoid using it on wounds or damaged skin, and be careful not to get it in your eyes. Do not wrap the area tightly. If you notice any redness, irritation, or if your condition worsens or does not improve after seven days, stop using the product and consult your doctor. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What should I do before applying the product?

Cleanse the skin thoroughly with a soft foam deep cleanse before applying.

How often should I apply the product?

Cover the entire affected area with a thin layer 1 to 2 times daily. Start with 1 application daily, then gradually increase to 2 times daily if needed or as directed by a doctor.

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. Do not use on wounds or damaged skin, and avoid contact with eyes.

What should I do if I experience redness or irritation?

Stop use and ask a doctor if redness is present, irritation develops, or if the condition worsens or symptoms persist for more than 7 days.

What should I do if the product is swallowed?

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

How should I store the product?

Store at room temperature, and check the lot number and expiration date located on the crimp or box.

Is there any specific information for nursing mothers?

No specific information regarding nursing mothers is provided.

Is this product safe for use during pregnancy?

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

What should I do if I have questions about using this product?

If you have any questions or concerns, consult your doctor or healthcare provider.

Packaging Info

Below are the non-prescription pack sizes of Controlling Balm with Tea Tree Oil (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Controlling Balm with Tea Tree Oil.
Details

Drug Information (PDF)

This file contains official product information for Controlling Balm with Tea Tree Oil, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the treatment of specific medical conditions as determined by healthcare professionals. There are no known teratogenic effects associated with this drug, nor are there any reported nonteratogenic effects.

Limitations of use have not been specified; however, healthcare providers should consider individual patient circumstances when prescribing this medication.

Dosage and Administration

Healthcare professionals are advised to cleanse the skin thoroughly with a soft foam deep cleanser prior to application. The medication should be applied as a thin layer to the entire affected area.

Initially, the recommended dosing is one application daily. Based on the patient's response and as directed by a physician, the frequency may be increased to two applications 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

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

For external use only. This product should not be applied to wounds or damaged skin. Healthcare professionals are advised to instruct patients to use the product strictly as directed, ensuring that contact with the eyes is avoided. Additionally, it is important to advise against tight bandaging of the area where the product is applied.

Patients should be informed to discontinue use and consult a physician if any of the following occur: the presence of redness, development of irritation, worsening of the condition, or if symptoms persist for more than 7 days. Furthermore, if symptoms resolve and then recur within a few days, medical advice should be sought.

In the event of accidental ingestion, immediate medical assistance should be obtained, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should remain vigilant in monitoring patients for these adverse effects and ensure that appropriate follow-up is conducted to assess the patient's response to treatment.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be applied to wounds or damaged skin. It is crucial for patients to use the product only as directed, avoiding contact with the eyes and refraining from tightly bandaging the area of application.

In the event that redness is present, irritation develops, or if the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, it is recommended that patients seek medical advice. These precautions are essential to ensure the safe and effective use of the product.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Controlling Balm with Tea Tree Oil (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Controlling Balm with Tea Tree Oil.
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 available 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 regarding the use of Controlling Balm with Tea Tree Oil during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant patients, as the potential risks and effects on fetal outcomes remain undetermined. Women of childbearing potential should be advised to consult their healthcare provider before using this product during pregnancy.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any 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

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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. 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 vital to ensure the safety of children and to address any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in packaging that includes a lot number and expiration date, which can be found on the crimp or box. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the specified storage conditions.

Additional Clinical Information

The product is intended for topical administration, with a recommended application of a thin layer to the entire affected area 1 to 2 times daily. Patients should begin with one application daily and may increase to two times daily as needed or as directed by a healthcare professional. In cases of bothersome dryness or peeling, the frequency should be reduced to once a day or every other day.

Clinicians should counsel patients that the product is for external use only and must not be applied to wounds or damaged skin. It is important to use the product only as directed, avoiding contact with the eyes and not applying tight bandages. Patients should be advised to discontinue use and consult a doctor if redness, irritation, or worsening of the condition occurs, or if symptoms persist beyond 7 days or recur after clearing. Additionally, the product should be kept out of reach of children, and immediate medical assistance should be sought if ingested.

Drug Information (PDF)

This file contains official product information for Controlling Balm with Tea Tree Oil, 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 Controlling Balm with Tea Tree Oil, 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.