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Clearcalm Non-Drying Acne Treatment

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This product has been discontinued

Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
November 9, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Gel
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 2019
Label revision date
November 9, 2023
Manufacturer
Ren Ltd.
Registration number
M006
NDC root
51417-0005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Acne is a common skin condition that can affect people of all ages, and there are various treatments available to help manage it. This medication is specifically used for the treatment of acne, helping to reduce the appearance of blemishes and improve skin clarity.

By targeting the underlying causes of acne, this treatment can assist in promoting healthier skin and preventing future breakouts. If you're struggling with acne, this medication may be a helpful option to consider in your skincare routine.

Uses

If you're dealing with acne, this medication is specifically designed 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 (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safer option for those concerned about potential side effects related to pregnancy or other conditions. Always consult with your healthcare provider to determine if this treatment is right for you.

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 do this one to three times a day, depending on your needs and your doctor's advice.

To avoid excessive drying of your skin, it's best to start with just one application each day. If your skin tolerates it well, you can gradually increase to two or three applications daily. However, if you notice any bothersome dryness or peeling, reduce your application to once a day or even every other day. This way, you can find the right balance for your skin while still getting the benefits of the treatment.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no explicit "do not take" or "do not use" instructions provided, it is important to consult with your healthcare provider for personalized advice and to ensure safe use of the medication. Always prioritize open communication with your doctor about any concerns or questions you may have.

Side Effects

This product is intended for external use only. While using it, you may experience skin irritation and dryness, especially if you are using another topical acne medication at the same time. To minimize the risk of irritation, it’s best to use only one topical acne treatment at a time.

Please keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This medication is for external use only, so be sure to apply it only to your skin. If you are using another topical acne treatment, 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 products.

In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center. Always prioritize your safety and well-being when using any medication.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose has occurred.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. It is not recommended for use while you are pregnant because there may be potential risks to your developing baby. Always consult with your healthcare provider for guidance and to discuss any concerns you may have regarding medications during this time.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Clearcalm Non-Drying Acne Treatment for nursing mothers. Additionally, the information provided does not mention any particular considerations or precautions related to lactation (the process of producing breast milk).

As always, if you have any concerns about using a product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

When using this medication on children, start with one application per day to avoid excessive drying of the skin. You can gradually increase to two or three times a day if necessary, but always follow your doctor's advice. If you notice any bothersome dryness or peeling, reduce the application to once a day or every other day.

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, it’s important to consult with a healthcare provider for personalized advice. 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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and effective for your specific health needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help ensure that any medications you take are safe and appropriate for your liver 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 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 simple guidelines will help you use the product safely and effectively.

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 then gradually increase to two or three times daily if needed or as directed by your doctor. If you experience bothersome dryness or peeling, reduce the application to once a day or every other day.

FAQ

What is this product used for?

This product is used for the treatment of acne.

How should I apply this product?

Clean the skin thoroughly before applying a thin layer to the entire affected area one to three times daily.

What should I do if my skin becomes dry or irritated?

If you experience bothersome dryness or peeling, reduce application to once a day or every other day.

Is this product safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use due to potential risks to the fetus.

What precautions should I take when using this product?

For external use only. Avoid using another topical acne medication at the same time to reduce the risk of skin irritation.

How should I store this product?

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

What should I do if I accidentally swallow this product?

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

Packaging Info

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

Packaging configurations for Clearcalm Non-Drying Acne Treatment.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic or nonteratogenic effects mentioned associated with the use of this drug.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleaned prior to the application of this product. The recommended application involves covering the entire affected area with a thin layer. This can be done one to three times daily, depending on the patient's needs and the physician's guidance.

To minimize the risk of excessive drying of the skin, it is advisable to initiate treatment with one application per day. Based on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily as necessary or as directed by a healthcare provider.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once daily or every other day to alleviate these side effects.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of this product with other topical acne medications, as this may increase the risk 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 adverse effects.

In cases of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. It is crucial to ensure that patients are aware of these precautions to promote safe and effective use of the medication.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if another topical acne medication is used concurrently. It is advised that only one topical acne medication be utilized at a time to minimize the risk of irritation.

This product is for external use only. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. It is crucial to keep this product out of reach of children to prevent any potential harm.

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 Clearcalm Non-Drying Acne Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Clearcalm Non-Drying Acne Treatment.
Details

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is recommended.

For topical application, it is advised to initiate treatment with one application daily. Depending on the patient's response and as directed by a healthcare professional, the frequency may be gradually increased to two or three times daily. Care should be taken to monitor for excessive drying of the skin; if bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Safety during pregnancy has not been established for this medication. It is contraindicated for use in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the benefits and risks when prescribing this medication to women of childbearing potential and advise them on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of Clearcalm Non-Drying Acne Treatment in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this treatment in nursing mothers without specific concerns related to breastfeeding.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 to seek immediate medical assistance or contact a Poison Control Center if the medication is swallowed. It is crucial for patients to understand the potential risks associated with accidental ingestion and the importance of prompt action.

Additionally, healthcare providers should inform patients about the likelihood of skin irritation and dryness when using this medication in conjunction with other topical acne treatments. Patients should be counseled 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 medication 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 per day and may gradually increase to two or three times daily as needed or directed by a healthcare professional. In cases where bothersome dryness or peeling occurs, it is advised to reduce the frequency of application to once a day or every other day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Clearcalm Non-Drying Acne 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 Clearcalm Non-Drying Acne 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.

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.