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Purity Made Simple

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Active ingredient
Salicylic Acid 0.5 µg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
November 19, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 0.5 µg/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
November 19, 2024
Manufacturer
Philosophy, Inc.
Registration number
M006
NDC root
50184-1060
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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

This product is an exfoliating clay mask designed to treat acne. It contains salicylic acid, which is a common ingredient known for its effectiveness in managing acne by helping to unclog pores and reduce inflammation.

In addition to its acne-fighting properties, the product reflects a philosophy of purity and intention, emphasizing a commitment to treating both the skin and others well.

Uses

If you're dealing with acne, this medication is designed specifically to help treat this common skin condition. Acne can be frustrating, but with the right treatment, you can see improvements in your skin's appearance and health.

It's important to note that this medication does not have any known teratogenic effects, meaning it does not cause birth defects. Additionally, there are no reported nonteratogenic effects, which means it doesn't have harmful effects that aren't related to birth defects either. Always consult with your healthcare provider for personalized advice and to ensure this treatment is right for you.

Dosage and Administration

To use this product effectively, start by applying it to clean, dry skin. Gently massage the product into your skin, paying special attention to your t-zone (the area of your forehead and nose that tends to be oilier) and any other oily areas.

Once applied, let the product sit on your skin for 5 to 10 minutes, or until the clay is completely dry. After that, rinse it off with warm water. If you're looking for a deeper exfoliation (removal of dead skin cells), you can increase the intensity of your massage during application and also give your skin a second gentle massage while rinsing. For best results, use this treatment twice a week.

What to Avoid

It's important to take care when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence, you should avoid contact with your eyes. If this happens, make sure to flush your eyes with plenty of water. If irritation continues, please consult a physician for further advice. Your safety is a priority, so always follow these guidelines closely.

Side Effects

It's important to note that this product is for external use only. If you are using other topical acne treatments at the same time or right after applying this product, you may experience increased dryness or irritation of your skin. If this happens, it's best to use only one medication unless your doctor advises otherwise.

Always pay attention to how your skin reacts and consult with a healthcare professional if you have any concerns about side effects.

Warnings and Precautions

This product is intended for external use only. If you are using other topical acne medications at the same time or right after applying this product, you may experience increased dryness or irritation of your skin. If this happens, it’s best to stop using the additional medication and stick to just one, unless your doctor advises otherwise.

If you notice any severe reactions or if your skin condition worsens, stop using the product immediately and contact your doctor for guidance. Always prioritize your skin's health and consult with a healthcare professional if you have any concerns.

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

When it comes to using this medication during pregnancy, specific information about its safety and any necessary dosage adjustments is not provided. Therefore, if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before starting this medication. They can help you understand any potential risks and make informed decisions about your treatment options. Always prioritize open communication with your doctor regarding your health and any medications you may be considering during this important time.

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 passed into breast milk or if it poses any risk to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

Currently, there is no specific information available regarding the use of this medication in children. This means that there are no recommended ages, dosage adjustments, or safety precautions outlined for pediatric patients (children). If you are considering this medication for a child, it is essential to consult with a healthcare professional to ensure it is appropriate and safe for their specific needs. Always prioritize your child's health and well-being by seeking expert advice.

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 is safe and effective for your specific health needs. They can help determine the best approach for managing your condition while considering your kidney health.

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 (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to be cautious when using this product alongside other topical acne medications. Using them together or right after each other can lead to increased dryness or irritation of your skin. If you notice these side effects, it's best to limit yourself to one medication unless your healthcare provider advises otherwise.

Always discuss any medications or treatments you are using with your healthcare provider to ensure they work safely and effectively for you. Your skin's health is important, and your provider can help you find the best approach.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it 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 product is applied topically, meaning you will put it directly on your skin, and it is recommended to use it twice a week for best results. Be cautious, as it may cause eye irritation. To avoid this, keep it away from your eyes. If it does come into contact with your eyes, rinse them thoroughly with water. If irritation continues, you should consult a physician for further advice.

FAQ

What is the primary use of this product?

This product is primarily used for the treatment of acne.

How should I apply the product?

Gently massage the product onto clean, dry skin, focusing on your t-zone and oily areas.

How long should I leave the product on my skin?

Leave the product on your skin for 5–10 minutes, or until the clay is completely dry, then rinse with warm water.

How often should I use this product?

It is recommended to use this product two times per week.

Are there any warnings I should be aware of?

This product is for external use only and may cause eye irritation. Avoid contact with eyes, and if contact occurs, flush with plenty of water.

Can I use this product with other acne medications?

Using other topical acne medications at the same time may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Is there any information regarding use during pregnancy or nursing?

There is no specific information provided regarding use during pregnancy or nursing mothers.

What should I do if I experience irritation?

If irritation persists after contact with eyes or skin, consult a physician.

How should I store this product?

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

Packaging Info

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

Packaging configurations for Purity Made Simple.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This exfoliating clay mask is formulated with salicylic acid, specifically designed for the treatment of acne. The product is available in a dosage form of 75 ml (2.5 fl. oz.).

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 the product onto clean, dry skin, with particular focus on the t-zone and oily areas. The product should be left on the skin for a duration of 5 to 10 minutes, or until the clay is completely dry. Following this, the patient should rinse the product off with warm water.

For patients seeking deeper exfoliation, it is recommended to increase the intensity of the massage during application. Additionally, while rinsing with water, performing a second massage can enhance the exfoliation effect.

The product is recommended for use two times per week to achieve optimal results.

Contraindications

Use of this product is contraindicated in individuals with a history of eye contact. In the event of contact with the eyes, it is essential to flush with plenty of water. If irritation persists after flushing, consultation with a physician is advised.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of other topical acne medications while using this product, as this may lead to increased dryness or irritation of the skin. In cases where such reactions occur, it is recommended that only one medication be utilized unless otherwise directed by a healthcare provider. Monitoring for signs of excessive dryness or irritation is advised to ensure patient safety and comfort.

Side Effects

Patients should be aware that this product is intended for external use only. The concurrent use of other topical acne medications, either simultaneously or immediately following the application of this product, may lead to increased dryness or irritation of the skin. In such cases, it is advised that only one medication be utilized unless otherwise directed by a healthcare professional.

Monitoring for these adverse reactions is essential to ensure patient safety and comfort during treatment.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advisable to limit the use to one medication at a time unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

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

Packaging configurations for Purity Made Simple.
Details

Pediatric Use

There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

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, given the lack of targeted data.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning 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 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 patients closely for any signs or symptoms that may arise following 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 intervention strategies.

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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to gently massage the product onto clean, dry skin, paying particular attention to the t-zone and areas prone to oiliness. Patients should be instructed to leave the product on their skin for 5 to 10 minutes, or until the clay is completely dry, and then rinse it off with warm water.

For those seeking deeper exfoliation, healthcare providers may recommend increasing the intensity of the massage during application and performing a second massage while rinsing with water. It is advisable to use this product twice a week for optimal results.

Providers should also inform patients that the product may cause eye irritation and emphasize the importance of avoiding contact with the eyes. In the event of accidental contact, patients should flush their eyes with plenty of water. If irritation persists, they should be encouraged to consult a physician for further evaluation and care.

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 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 frequency of two times per week. Clinicians should counsel patients that the product may cause eye irritation; therefore, it is crucial to avoid contact with the eyes. In the event of contact, patients should flush the eyes with plenty of water and seek medical advice if irritation persists.

Drug Information (PDF)

This file contains official product information for Purity Made Simple, 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 Purity Made Simple, 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.