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Ultra Clear Treatment

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Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 7, 2025
Active ingredient
Salicylic Acid 2 g/100 mL
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 7, 2025
Manufacturer
ULTRACEUTICALS PTY LIMITED
Registration number
M006
NDC root
10028-051

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

Ultraceuticals Ultra Clear Treatment Lotion is an acne treatment lotion designed to help manage and reduce acne breakouts. It contains two active ingredients: salicylic acid and mandelic acid. Salicylic acid is known for its ability to penetrate pores and help clear out excess oil and dead skin cells, while mandelic acid is a gentler exfoliant that can improve skin texture and tone.

This lotion is formulated to support clearer skin by targeting the underlying causes of acne. If you experience any severe skin irritation while using this product, it is important to stop use and consult a doctor.

Uses

If you're dealing with acne, you might find relief with an acne treatment lotion that contains salicylic acid and mandelic acid. These ingredients work together to help clear your skin and reduce breakouts.

It's important to note that this product has not been shown to cause teratogenic effects (which means it doesn't cause birth defects) or any other nonteratogenic effects. This makes it a potentially safe option for many users looking to improve their skin health.

Dosage and Administration

Before using this product, make sure to clean your skin thoroughly. Once your skin is clean, apply a thin layer of the product to the entire affected area. You can start by using it once a day. If you feel you need more treatment, you can gradually increase the application to two or three times a day, but only if directed by your doctor.

Keep an eye on how your skin reacts. If you notice any dryness or peeling, it’s best to reduce your application to once a day or even every other day. This way, you can still benefit from the treatment while minimizing any irritation.

What to Avoid

It's important to take care when using this medication. You should avoid contact with your eyes; if this happens, rinse your eyes thoroughly with water to remove any residue. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow these guidelines to ensure your safety and well-being.

Side Effects

It's important to be aware of some potential side effects when using this medication. You should only use it externally, as it is not meant for internal use. If you are using another topical acne treatment at the same time, you may experience increased skin irritation and dryness. To minimize this risk, it's best to use only one topical acne medication at a time.

Additionally, be cautious to avoid contact with your eyes. If the medication does come into contact with your eyes, rinse them thoroughly with water to remove it. Taking these precautions can help you use the medication safely and effectively.

Warnings and Precautions

This medication is for external use only, so please do not apply it to any areas other than your skin. If you are using another topical acne medication, be cautious, as using both at the same time can increase the risk of skin irritation and dryness. If you experience irritation, it’s best to stop using one of the medications.

Make sure to avoid getting this product in your eyes. If it does come into contact with your eyes, rinse them thoroughly with water to remove the medication. If you have any concerns or experience severe irritation, stop using the product and contact your doctor for further advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

The safety of this product during pregnancy has not been established, and it is important to be cautious. Salicylic acid, a common ingredient in some medications, is contraindicated (not recommended) for use during pregnancy due to potential risks to your developing baby. There is a risk of teratogenic effects, which means it could cause developmental issues in the fetus.

If you are pregnant or planning to become pregnant, it is best to avoid using this product. Always consult your healthcare provider for safer alternatives that are appropriate for your situation. Your health and the health of your baby are the top priority.

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 excreted in breast milk or any potential risks to your infant associated with its use during lactation. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

The information provided does not specifically address the use of this medication in children. There are no recommended ages, dosage differences, or safety concerns outlined for pediatric (children's) use. As a parent or caregiver, it's important to consult with a healthcare professional for guidance on the appropriate use of this medication for children, as they can provide tailored advice based on your child's specific needs.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. 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 is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 with liver impairment.

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

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

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

Be mindful of potential skin irritation. If irritation becomes severe, stop using the product and consult your doctor. Using another topical acne medication at the same time can increase the likelihood of irritation, so it's advisable to use only one at a time. Avoid contact with your eyes; if it happens, rinse your eyes thoroughly with water. If you plan to be outdoors, apply sunscreen after using this product, and discontinue use if you notice any irritation or sensitivity.

FAQ

What is Ultraceuticals Ultra Clear Treatment Lotion used for?

It is an acne treatment lotion that contains Salicylic Acid and Mandelic Acid.

How should I apply this lotion?

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 if needed.

What should I do if I experience skin irritation?

If skin irritation becomes severe, stop use and ask a doctor. You may also need to reduce application to once a day or every other day.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and Salicylic Acid is contraindicated due to potential risks to the fetus.

Can I use this lotion while breastfeeding?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What precautions should I take when using this lotion?

Avoid contact with the eyes; if contact occurs, rinse thoroughly with water. For external use only, and avoid using it with other topical acne medications to reduce the risk of irritation.

How should I store this product?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Ultra Clear Treatment.
Details

Drug Information (PDF)

This file contains official product information for Ultra Clear Treatment, 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 specified drug.

Uses and Indications

This drug is indicated for the treatment of acne. It contains salicylic acid and mandelic acid, which work synergistically to help reduce acne lesions and improve overall skin appearance.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should 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 dryness or peeling is observed, it is recommended to reduce the application frequency to once daily or every other day to mitigate these effects.

Contraindications

Use of this product is contraindicated in patients with a history of eye contact. In the event of contact with the eyes, it is imperative to rinse thoroughly with water to mitigate potential irritation. No other contraindications have been identified.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the application of this product may lead to skin irritation and dryness, particularly when used concurrently with other topical acne medications. To minimize the risk of irritation, it is recommended that patients use only one topical acne medication at a time.

Additionally, it is crucial to avoid contact with the eyes. In the event of accidental contact, patients should be instructed to rinse their eyes thoroughly with water to ensure complete removal of the product. Monitoring for signs of irritation or adverse reactions is advised to ensure patient safety and treatment efficacy.

Side Effects

Patients using this medication should be aware that it is intended for external use only. The use of this product in conjunction with other topical acne medications may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients limit their use to one topical acne medication at a time to mitigate these effects.

Additionally, care should be taken to avoid contact with the eyes. Should contact occur, patients are advised to rinse the eyes thoroughly with water to ensure the medication is removed.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Ultra Clear Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ultra Clear Treatment.
Details

Pediatric Use

Pediatric use has not been specifically addressed in the provided information. There are no recommended age ranges, dosing differences, safety concerns, or special precautions for children mentioned. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the lack of available data.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of this product during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the risk of teratogenic effects associated with its use. Pregnant women should avoid using this product and consult a healthcare provider for alternative treatments. It is essential for healthcare professionals to consider these factors when advising women of childbearing potential regarding the use of 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 about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and be prepared to act swiftly in the event of an overdose, ensuring that appropriate measures are taken to safeguard patient health.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that the use of this medication may increase the likelihood of skin irritation and dryness, particularly if another topical acne medication is being used concurrently. It is important to instruct patients to use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. In the event that contact occurs, patients should be instructed to rinse their eyes thoroughly with water to ensure the medication is removed.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the entire affected area one to three times daily. Patients should begin with one application daily and may gradually increase to two or three times daily as needed or directed by a clinician. In cases of dryness or peeling, it is advised to reduce the frequency to once a day or every other day.

Clinicians should counsel patients on potential skin irritation, advising them to discontinue use and consult a doctor if irritation becomes severe. It is important to note that the likelihood of skin irritation and dryness increases when using another topical acne medication concurrently; therefore, patients should limit use to one topical acne treatment at a time. Patients should also avoid contact with the eyes, rinsing thoroughly with water if contact occurs. Additionally, when exposed to sunlight, patients should apply sunscreen after using the product, and if any irritation or sensitivity arises, they should stop using both products and seek medical advice.

Drug Information (PDF)

This file contains official product information for Ultra Clear Treatment, 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 Ultra Clear Treatment, 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.