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Cetaphil Gentle Clear Triple-Action Acne Serum

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Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
November 16, 2023
Active ingredient
Salicylic Acid 5 mg/1 mL
Other brand names
Dosage form
Solution
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2022
Label revision date
November 16, 2023
Manufacturer
Galderma Laboratories, L. P.
Registration number
M006
NDC root
0299-4135

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Drug Overview

Cetaphil® is a triple-action acne serum designed to help manage acne effectively. It contains 0.5% salicylic acid, which is a common ingredient used to treat acne by helping to unclog pores and reduce breakouts. In addition to salicylic acid, this serum also includes niacinamide (a form of vitamin B3 that helps soothe and improve skin texture) and prebiotics, which support skin health.

This product is dermatologist recommended and is suitable for sensitive skin, making it a gentle option for those looking to improve their skin's appearance. With regular use, you may notice visible improvements in breakouts within just three days, as it hydrates, soothes, and resurfaces the skin.

Uses

If you're dealing with acne, this medication can help manage your condition effectively. It is specifically designed to treat acne, helping to reduce breakouts and improve the overall appearance of your skin.

You can feel reassured that there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication. Additionally, there are no reported nonteratogenic effects, making it a safe option for those looking to manage their acne.

Dosage and Administration

When you start using this product, it's important to test your skin's sensitivity first. For the first three days, apply a small amount to one or two small areas of the affected skin. If you don’t experience any discomfort, you can proceed with the regular application instructions.

Before applying the product, make sure to clean your skin thoroughly. You should then cover the entire affected area with a thin layer of the product. Initially, it’s best to apply it just once a day to see how your skin reacts. If your skin tolerates it well, you can gradually increase the application to two or three times a day, as needed or directed by your doctor. Keep in mind that if you notice excessive dryness or peeling, you should reduce the frequency of application to once a day or even every other day.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always follow the guidance provided and consult with a healthcare professional if you have any questions or concerns.

Side Effects

When using this product, 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. Additionally, be careful to avoid contact with your eyes; if this happens, rinse your eyes thoroughly with water.

If you notice that the irritation becomes severe, it’s important to stop using the product and consult a doctor for further advice.

Warnings and Precautions

This product is for external use only. While using it, be aware that skin irritation and dryness may increase if you use another topical acne medication at the same time. To minimize irritation, it’s best to use only one topical acne treatment at a time. Additionally, avoid getting the product in your eyes; if this happens, rinse your eyes thoroughly with water.

If you experience severe irritation, stop using the product and consult your doctor. In the event that the product is swallowed, seek medical help immediately or contact a Poison Control Center.

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

The safety of this product during pregnancy has not been established, so it's important to be cautious. Generally, the use of salicylic acid is not recommended for pregnant individuals due to potential risks to the developing fetus. There may be a risk of teratogenic effects, which means it could cause developmental issues in the baby.

If you are pregnant or planning to become pregnant, it's essential to consult your healthcare provider before using this product. They can help you understand the risks and determine the best course of action for your health and the health of your baby.

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 to prevent accidental ingestion. If your child swallows any of it, seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

When considering the use of Cetaphil Gentle Clear Triple-Action Acne Serum for older adults, it's important to note that the drug insert does not provide specific information about how this product may affect elderly patients. This means there are no special dosage adjustments, safety concerns, or precautions outlined for older individuals.

If you or a caregiver are considering this serum, it may be wise to consult with a healthcare professional to ensure it is appropriate for your skin type and any other health conditions you may have. Always prioritize safety and effectiveness when trying new skincare products.

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 be adjusted 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 condition. They can help monitor your kidney health and make any necessary changes 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 ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

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 treatment 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

You can feel confident knowing that there are no specific storage or handling instructions for this product or device. This means you can use it as intended without worrying about special conditions.

Always ensure that you handle the product with care to maintain its integrity and safety. If you have any questions about its use or safety, don't hesitate to reach out for more information.

Additional Information

You will apply this medication topically, which means you will apply it directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Cetaphil®?

Cetaphil® is a Triple-Action Acne Serum designed for the management of acne.

What are the key ingredients in Cetaphil®?

Cetaphil® contains 0.5% Salicylic Acid, Niacinamide, and Prebiotic, which help hydrate, soothe, and resurface the skin.

How should I apply Cetaphil®?

Clean the skin thoroughly before applying a thin layer to the affected area one to three times daily, starting with one application daily to avoid excessive drying.

What should I do if I experience irritation?

If irritation becomes severe, stop using the product and consult a doctor.

Is Cetaphil® safe to use during pregnancy?

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

Can I use Cetaphil® while breastfeeding?

There are no specific warnings regarding the use of Cetaphil® in nursing mothers, but consult a healthcare provider for personalized advice.

What should I do if I accidentally swallow Cetaphil®?

If swallowed, seek medical help or contact a Poison Control Center immediately.

Is Cetaphil® suitable for sensitive skin?

Yes, Cetaphil® is dermatologist recommended and suitable for sensitive skin.

Are there any contraindications for using Cetaphil®?

No specific contraindications are listed for Cetaphil®.

Packaging Info

Below are the non-prescription pack sizes of Cetaphil Gentle Clear Triple-Action Acne Serum (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cetaphil Gentle Clear Triple-Action Acne Serum.
Details

Drug Information (PDF)

This file contains official product information for Cetaphil Gentle Clear Triple-Action Acne Serum, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Cetaphil Acne Gentle Clear Triple-Action Acne Serum contains 0.5% Salicylic Acid as its active ingredient, complemented by Niacinamide and Prebiotic. This formulation is indicated for the treatment of acne and is specifically designed for sensitive skin types. The product is presented in a volume of 1 fluid ounce (30 mL). It is dermatologist recommended and claims to hydrate, soothe, and resurface the skin, aiming to visibly improve breakouts within three days.

Uses and Indications

This drug is indicated for the management of acne.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For new users, it is recommended to conduct a sensitivity test by applying the product sparingly to one or two small affected areas for the first three days. If no discomfort is experienced, the user may proceed with the following application instructions.

Prior to application, the skin should be cleaned thoroughly. The product should then be applied to the entire affected area in a thin layer. The recommended frequency of application is one to three times daily. To minimize the risk of excessive skin drying, it is advisable to start with one application per day. The frequency may be gradually increased to two or three times daily as needed or as directed by a healthcare professional.

In the event that bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients that the likelihood of skin irritation and dryness may increase when this product is used concurrently with other topical acne medications. In such cases, it is recommended to limit the use to one topical acne treatment at a time to minimize the risk of irritation.

Patients should be cautioned to avoid contact with the eyes. In the event of accidental contact, they should rinse the eyes thoroughly with water to mitigate potential adverse effects.

If patients experience severe irritation, they should discontinue use immediately and consult a healthcare provider for further evaluation and guidance.

In cases of ingestion, it is imperative to seek medical assistance or contact a Poison Control Center without delay to ensure appropriate management.

Side Effects

Patients using this product should be aware that it is for external use only. The use of this product in conjunction with other topical acne medications may increase the likelihood of skin irritation and dryness. In the event that irritation occurs, it is recommended that patients limit their use to one topical acne treatment at a time.

Additionally, care should be taken to avoid contact with the eyes. Should contact occur, patients are advised to rinse their eyes thoroughly with water. If irritation becomes severe, patients should discontinue use and consult a healthcare professional for further guidance.

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 treatment be utilized at a time. If irritation occurs, discontinuation of additional topical treatments is recommended to allow the skin to recover. Monitoring for signs of irritation is essential when initiating or adjusting treatment regimens involving topical acne medications.

Packaging & NDC

Below are the non-prescription pack sizes of Cetaphil Gentle Clear Triple-Action Acne Serum (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cetaphil Gentle Clear Triple-Action Acne Serum.
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 local Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information regarding the use of Cetaphil Gentle Clear Triple-Action Acne Serum in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this product to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

The safety of this product during pregnancy has not been established. The use of salicylic acid during pregnancy is generally not recommended due to potential risks to the fetus. There may be a risk of teratogenic effects associated with the use of salicylic acid in pregnant individuals. Therefore, pregnant women should consult a healthcare provider before using this product to discuss potential risks and benefits.

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 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 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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies.

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 keep the 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 a 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 various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling instructions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage conditions.

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 Cetaphil Gentle Clear Triple-Action Acne Serum, 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 Cetaphil Gentle Clear Triple-Action Acne Serum, 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.