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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
73572-011

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Drug Overview

You can use this medication to help treat acne, a common skin condition that causes pimples and blemishes. It works by targeting the factors that contribute to acne, helping to reduce breakouts and improve the overall appearance of your skin. If you're struggling with acne, this treatment may be a helpful option to consider in your skincare routine.

Uses

If you're dealing with acne, this medication can help you manage and treat your condition effectively. Acne is a common skin issue that can affect people of all ages, and using this treatment may lead to clearer skin and improved confidence. Always consult with your healthcare provider to ensure it's the right option for you.

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 will help keep your skin clean and refreshed.

What to Avoid

It's important to keep this medication 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, stop using it and consult your doctor for further guidance.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication. However, always prioritize safety and follow the instructions provided.

Side Effects

When using this product, it's important to remember that it is for external use only. If you experience any irritation while using it, you should stop using the product and consult your doctor for further advice.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas of your body. It's important to keep it out of reach of children. If a child accidentally swallows it, seek medical help or contact the Poison Control Center immediately.

If you experience any irritation while using this product, stop using it and consult your doctor for further advice. 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 the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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. Generally, it is not recommended due to potential risks to your developing baby, including possible teratogenic effects (which means it could cause developmental issues).

Before using any product containing salicylic acid, you should consult your healthcare provider. They can provide guidance on whether it's safe for you and if any dosage adjustments are necessary. It's best to avoid using this product unless specifically directed by a healthcare professional.

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. Always consult with your healthcare provider if you have any concerns or questions about 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. Always be vigilant about where you store medications to ensure your child's safety.

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 if you have hepatic impairment (issues with liver function).

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

Drug Interactions

It's important to be aware that using this product alongside another topical acne medication can increase the chances of skin irritation and dryness. To ensure your skin stays healthy and to avoid any unwanted side effects, you should discuss all medications and treatments you are using with your healthcare provider. They can help you determine the best approach for your skincare routine and minimize any potential interactions.

Storage and Handling

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

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or experiences reported after the medication has been on the market. If you have any specific questions or concerns about using this medication, it's best to consult with your healthcare provider.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How should I use this product?

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

Are there any contraindications for this product?

No specific contraindications are mentioned, but you should keep it out of reach of children.

What should I do if I experience irritation?

Stop use and ask your doctor if irritation occurs.

Is this product safe to use during pregnancy?

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

What precautions should pregnant women take?

Pregnant women should avoid using this product unless directed by a healthcare professional.

What should I do if the product is swallowed?

Get medical help or contact Poison Control Center right away if swallowed.

How should I store this product?

Store at room temperature, keep the container tightly closed, and protect it from light. 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

The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.

Uses and Indications

This drug is indicated for the treatment of acne.

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 thoroughly with warm water. Patients should then pat their skin dry with a clean towel.

Contraindications

Use is contraindicated in the following situations:

  • The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is required.

  • Discontinue use and consult a healthcare professional if irritation occurs.

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 a physician if any irritation occurs during the application of this product. Monitoring for signs of irritation is essential to ensure patient safety and comfort.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if irritation occurs.

Drug Interactions

Concurrent use of this product with other topical acne medications may increase the risk of skin irritation and dryness. It is advisable to monitor the skin condition closely when these products are used together. If significant irritation or dryness occurs, consideration should be given to adjusting the frequency of application or discontinuing one of the treatments to mitigate these effects.

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 this product. The use of salicylic acid during pregnancy is generally not recommended due to potential risks to the fetus, including the possibility of teratogenic effects. Pregnant patients should avoid using this product unless directed by a healthcare professional. It is advised that healthcare providers be consulted for guidance on use during pregnancy, as dosage adjustments may be necessary based on individual circumstances.

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 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, the following management procedures are recommended:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these measures in the event of an overdose, despite the lack of specific information regarding the substance in question.

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 the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact the Poison Control Center immediately.

Patients should be informed to discontinue use and consult their doctor if they experience any irritation. It is important to highlight that when using this product, the likelihood of skin irritation and dryness may increase if they are concurrently using another topical acne medication.

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 to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.