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Proven Acne Cleanser

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Active ingredient
Salicylic Acid 2 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
January 1, 2024
Active ingredient
Salicylic Acid 2 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
January 1, 2024
Manufacturer
Proven Skincare
Registration number
M006
NDC root
73572-010

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If you are a consumer or patient please visit this version.

Drug Overview

Proven312 is a medication specifically designed for the treatment of acne, a common skin condition that can cause pimples, blackheads, and other blemishes. It works to help clear your skin and reduce the appearance of acne, making it a helpful option for those struggling with this issue.

If you're considering Proven312, it's important to understand that it is intended to improve your skin's condition over time, contributing to a clearer complexion. Always consult with a healthcare professional to determine if this treatment is right for you.

Uses

If you're dealing with acne, this medication can help you manage and treat your condition effectively. It's specifically designed for the treatment of acne, aiming to improve your skin's appearance and health.

You can feel reassured knowing 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, making it a safe option for those looking to address their acne concerns.

Dosage and Administration

To use the cleanser effectively, start by dampening your face and neck with water. Then, gently massage 2 to 4 pumps of the cleanser onto your skin. This helps to remove dirt and impurities. After massaging, rinse your face thoroughly with warm water to wash away the cleanser. Finally, pat your skin dry with a clean towel. This simple routine can help keep your skin clean and refreshed.

What to Avoid

It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact the Poison Control Center immediately. Additionally, if you experience any irritation while using this product, make sure to use only one topical acne medication at a time to avoid worsening the irritation.

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this product. However, always prioritize safety and follow the usage instructions carefully.

Side Effects

When using this medication, it's important to remember that it is for external use only. This means you should not apply it internally or ingest it.

If you experience any unusual reactions or side effects, please consult your healthcare provider for guidance. Always prioritize your safety and well-being while using this product.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact the Poison Control Center.

If you experience any irritation while using this product, stop using it and consult your doctor. It's also important to use only one topical acne medication at a time to prevent potential skin irritation.

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, 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of using salicylic acid during pregnancy has not been established. In fact, using salicylic acid is not recommended because it may pose risks to your developing baby, including potential teratogenic effects (which means it could cause birth defects).

While there are no specific dosage modifications provided, it is crucial to exercise caution and consult with your healthcare provider before using any products containing salicylic acid during your pregnancy. Your health and the health of your baby should always come first.

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. Currently, there is also no information available about whether this product is passed into breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

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 the Poison Control Center. Taking quick action can be crucial in ensuring their safety. Always be vigilant and store medications securely to prevent any accidents.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. 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 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

Drug Interactions

It's important to be cautious when using multiple acne treatments at once. If you apply another topical acne medication alongside 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 you avoid any unnecessary discomfort.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

This medication is intended for external use only and is applied topically (on the skin). When using this product, be cautious about combining it with other topical acne treatments, as this can increase the risk of skin irritation and dryness. If you experience irritation, it's best to use only one topical acne medication at a time.

Make sure to keep this product out of reach of children. If it is accidentally swallowed, seek medical help or contact the Poison Control Center immediately.

FAQ

What is Proven312 used for?

Proven312 is used for the treatment of acne.

How should I use Proven312?

Gently massage 2-4 pumps of the cleanser over damp face and neck, then rinse with warm water and pat dry.

Are there any contraindications for Proven312?

There are no contraindications listed for Proven312.

What should I do if I swallow Proven312?

If swallowed, get medical help or contact Poison Control Center right away.

Can I use Proven312 during pregnancy?

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

Is Proven312 safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of Proven312 in nursing mothers.

What precautions should I take when using Proven312?

For external use only. Keep out of reach of children, and if irritation occurs, only use one topical acne medication at a time.

How should I store Proven312?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Proven Acne Cleanser.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Proven312 is a pharmaceutical compound characterized by its specific molecular structure and properties. The chemical formula is not provided, but it is essential to note that Proven312 is formulated for therapeutic use. The dosage form and appearance are also unspecified, indicating that further details may be required for comprehensive understanding.

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 reported.

Dosage and Administration

Healthcare professionals are advised to instruct patients to gently massage 2 to 4 pumps of the cleanser over a damp face and neck. Following the application, the product should be rinsed off thoroughly with warm water. Patients should then pat their skin dry with a clean towel.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is necessary. Additionally, if irritation occurs, the concurrent use of multiple topical acne medications is contraindicated to prevent exacerbation of skin irritation.

Warnings and Precautions

For external use only. It is imperative that this product is kept 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.

Healthcare professionals should advise patients to discontinue use and consult their physician if any irritation occurs. It is recommended that only one topical acne medication be used at a time to minimize the risk of adverse reactions.

Side Effects

Patients should be aware that the product is intended for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

Healthcare professionals are encouraged to monitor patients for any unexpected reactions and to report these findings to ensure comprehensive safety data is collected.

Drug Interactions

Concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the use to one topical acne medication at a time to minimize the potential for adverse effects. If irritation occurs, the patient should discontinue the use of additional topical agents and consult a healthcare professional for further guidance.

Packaging & NDC

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

Packaging configurations for Proven Acne Cleanser.
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

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

Safety during pregnancy has not been established for the use of salicylic acid. The use of salicylic acid is contraindicated in pregnant patients due to the potential risk to the fetus. There is a known risk of teratogenic effects associated with the use of salicylic acid during pregnancy. While dosage modifications are not specified, caution is advised when considering the use of this medication in women of childbearing potential. Healthcare professionals should carefully evaluate the risks and benefits before prescribing salicylic acid to pregnant patients.

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.

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 prescribing 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the substance involved in the overdose. Continuous assessment and supportive measures should be prioritized to ensure patient safety and optimal outcomes.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact the Poison Control Center immediately.

Patients should be informed that the use of this product may increase the likelihood of skin irritation and dryness, particularly if they are concurrently using another topical acne medication. It is important to counsel patients to use only one topical acne medication at a time to minimize the risk of irritation. If patients experience any signs of irritation, they should be instructed to discontinue use and consult their healthcare provider for further guidance.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically and is intended for external use only. Clinicians should advise patients that the likelihood of skin irritation and dryness increases when using this product concurrently with other topical acne medications. If irritation occurs, patients should limit their use to one topical acne medication at a time.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Proven Acne Cleanser, 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 Proven Acne Cleanser, 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.