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Acne Toner

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This product has been discontinued

Active ingredient
Salicylic Acid 0.5 g/0.5 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2015
Label revision date
July 11, 2024
Active ingredient
Salicylic Acid 0.5 g/0.5 mL
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 2015
Label revision date
July 11, 2024
Manufacturer
Bioelements, Inc.
Registration number
M006
NDC root
49825-136

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Drug Overview

Acne Toner is a topical solution designed to help clear acne and improve the overall appearance of your skin. This product comes in an 88 mL (3 Fl. Oz.) bottle and is part of an acne clearing system aimed at reducing breakouts.

When using Acne Toner, it's important to be mindful of potential skin irritation and dryness, especially if you are using other topical acne medications simultaneously. For the best results, consider using one topical acne treatment at a time to minimize irritation.

Uses

If you're dealing with skin irritation and dryness, especially while using topical acne medications, it's important to be cautious. Using more than one topical acne treatment at the same time can increase the likelihood of these side effects. To minimize irritation, it's best to stick to one topical acne medication at a time.

You can feel reassured that there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication. Additionally, there are no nonteratogenic effects noted, so you can use it without concerns about these specific risks.

Dosage and Administration

After you cleanse your skin, you can use this product both in the morning and at night. To apply it, pour some onto a cotton pad and gently wipe it over your skin, making sure to avoid the area around your eyes. There's no need to rinse it off afterward; just let it absorb into your skin.

If you notice any dryness or peeling, it’s a good idea to cut back on how often you use it. In that case, try using it just once a day instead of twice. This way, you can still enjoy the benefits while keeping your skin comfortable.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact the Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

It's important to note that this product is for external use only. This means you should not apply it to your eyes, mouth, or any internal areas. Always follow the instructions for use to ensure your safety and well-being. If you have any concerns or experience unusual reactions, please consult a healthcare professional.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. It's important to keep it out of reach of children to prevent accidental ingestion. If someone swallows the product, seek medical help immediately or contact the Poison Control Center for assistance.

Always use this product as directed, and if you have any concerns or experience unusual reactions, don’t hesitate to reach out to your healthcare provider for guidance. Your safety is a priority, 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

It is important to be cautious when considering the use of salicylic acid during pregnancy. The safety of this ingredient has not been established, and it is specifically contraindicated, meaning it should not be used, as it may pose potential risks to your developing baby.

If you are pregnant or planning to become pregnant, it is best to avoid using products that contain salicylic acid. Always consult with your healthcare provider for guidance on safe skincare options during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there are no specific warnings or recommendations related to nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks or concerns associated with breastfeeding while using this medication.

However, always consult with your healthcare provider for personalized advice and to ensure the safety of both you and your baby. Your healthcare provider can help you make informed decisions about your health and breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact the Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

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 your medication dosage may need to be adjusted. This is particularly true if your kidneys are not functioning as well as they should be. Regular monitoring of your renal function tests is essential to ensure your kidneys are managing medications effectively.

If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you should consider taking a lower dose of your medication. Always consult with your healthcare provider to determine the best approach for your specific situation.

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 be cautious when using multiple acne treatments at the same time. If you apply another topical acne medication along with this one, 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.

Always discuss your current medications and any new treatments with your healthcare provider. They can help you understand the best approach for your skin care routine and ensure that you avoid any unnecessary discomfort.

Storage and Handling

To ensure the best use of your product, store it at room temperature, away from direct sunlight and moisture. It's important to keep the product out of reach of children to prevent accidental ingestion or misuse. Remember, this product is for external use only, so avoid applying it to any internal areas. Once you open the product, be sure to discard it after use to maintain safety and effectiveness.

Additional Information

You should use this topical product after cleansing your skin, both in the morning and at night, while avoiding the eye area. Apply it to a cotton pad and gently wipe it over your skin without rinsing. If you experience dryness or peeling, reduce your usage to once a day.

It's important to keep this product out of reach of children. If swallowed, seek medical help or contact the Poison Control Center immediately. Be cautious when using this product alongside other topical acne medications, as this can increase the risk of skin irritation and dryness. For safety, remember that this product is for external use only.

FAQ

What is the Acne Toner - Acne Clearing System?

The Acne Toner - Acne Clearing System is a topical acne treatment available in a 88 mL (3 Fl. Oz.) bottle.

How should I use the Acne Toner?

Use the toner after cleansing, day and night, by applying it to a cotton pad and gently wiping it over your skin. Do not rinse.

What should I do if I experience dryness or peeling?

If dryness or peeling occurs, reduce usage to once a day.

Can I use other topical acne medications at the same time?

Skin irritation and dryness are more likely to occur if you use another topical acne medication simultaneously. If irritation occurs, only use one topical acne medication at a time.

Is this product safe to use during pregnancy?

Safety during pregnancy has not been established, and the use of salicylic acid is contraindicated due to potential risks to the fetus.

What precautions should I take when using this product?

Keep the product out of reach of children and avoid contact with the eye area. If swallowed, seek medical help or contact Poison Control Center immediately.

What are the storage instructions for the Acne Toner?

Store the Acne Toner at room temperature and discard it after opening.

Is there any information regarding use in elderly patients?

No specific information regarding geriatric use or dosage adjustments for elderly patients is provided.

Are there any contraindications for this product?

There are no listed contraindications, but pregnant women should avoid using this product.

What should I do if I experience skin irritation?

If you experience skin irritation, discontinue use and consult a healthcare professional.

Packaging Info

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

Packaging configurations for Acne Toner.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The Acne Toner is a component of the Acne Clearing System, designed for topical application. It is packaged in a volume of 88 mL (3 Fl. Oz.). This formulation is intended to assist in the management of acne-prone skin.

Uses and Indications

This drug is indicated for the treatment of skin irritation and dryness associated with topical acne medications. It is recommended that only one topical acne medication be used at a time to minimize the risk of irritation.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The product should be applied after cleansing the skin, both in the morning and evening, while avoiding the eye area. A cotton pad should be used to gently wipe the product over the skin. It is important not to rinse the product off after application.

In cases where dryness or peeling occurs, the frequency of application should be reduced to once daily.

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 the Poison Control Center contacted.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

This product should be stored out of reach of children to prevent accidental ingestion or misuse. Proper precautions must be taken to ensure that children do not have access to this product, as it poses a risk to their safety.

Side Effects

For external use only. Patients should be advised to avoid contact with eyes and mucous membranes. In the event of accidental contact, the affected area should be rinsed thoroughly with water. No specific adverse reactions have been reported in clinical trials or postmarketing experiences beyond this warning.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate this risk, it is advised that only one topical acne medication be used at a time. If irritation occurs, discontinuation of one of the medications is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

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

Packaging configurations for Acne Toner.
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 the Poison Control Center should be contacted without delay.

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.

Due to the lack of data, it is advisable to closely monitor elderly patients for any potential adverse effects and to consider individual patient factors when determining the appropriateness of therapy.

Pregnancy

Safety during pregnancy has not been established for this product. The use of salicylic acid is contraindicated in pregnant patients due to the potential risk to the fetus. Therefore, pregnant women should avoid using this product to mitigate any potential adverse effects on fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. Additionally, a reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 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. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact the Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It is essential to store the product at room temperature to maintain its efficacy. Additionally, it should be kept out of reach of children to prevent accidental ingestion or misuse. This product is intended for external use only, and it is important to discard any remaining product after opening to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically, recommended for use after cleansing both day and night, while avoiding the eye area. It should be applied to a cotton pad and gently wiped over the skin without rinsing. In cases of dryness or peeling, patients are advised to reduce usage to once daily.

Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed. It is important to note that skin irritation and dryness may increase if another topical acne medication is used concurrently; therefore, only one topical acne medication should be used at a time. The product is intended for external use only.

Drug Information (PDF)

This file contains official product information for Acne Toner, 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 Acne Toner, 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

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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.