Cetaphil Gentle Clear Mattifying Acne Moisturizer

Description

Cetaphil® ACNE GENTLE CLEAR is a mattifying acne moisturizer formulated with 0.5% salicylic acid, designed to treat acne while providing oil absorption and a matte finish. This product contains salicylic acid and prebiotic ingredients, making it suitable for sensitive skin. The moisturizer is packaged in a 3 FL OZ (89 mL) container and is distributed by Galderma Laboratories, L.P., located in Dallas, TX 75201, USA. It is manufactured in Canada and is dermatologist recommended.

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 during this period, the user may proceed with the general application instructions.

Prior to application, the skin should be cleaned thoroughly. The product should then be applied to cover the entire affected area with a thin layer. The recommended frequency of application is one to three times daily. To minimize the risk of excessive drying of the skin, 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 contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients that the likelihood of skin irritation and dryness may increase if another topical acne medication is used concurrently. 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 their eyes thoroughly with water. If irritation becomes severe, patients are instructed to discontinue use and consult a healthcare provider for further evaluation.

In cases of ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Healthcare professionals should ensure that patients are aware of these warnings and the importance of monitoring for any adverse reactions, particularly skin irritation, to ensure safe and effective use of the product.

Side Effects

Patients using this product should be aware that it is for external use only. The use of this product may lead to skin irritation and dryness, particularly if another topical acne medication is used concurrently. In such cases, it is advised that only one topical acne treatment be utilized at a time to minimize the risk of irritation.

Participants should also take care to avoid contact with the eyes. In the event of accidental contact, it is recommended to rinse the eyes thoroughly with water. If irritation becomes severe, patients are advised to discontinue use and consult a healthcare professional.

Drug Interactions

The concurrent use of multiple topical acne medications may increase the risk of skin irritation and dryness. To mitigate these effects, 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 Mattifying Acne Moisturizer (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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 Cetaphil Gentle Clear Mattifying Acne Moisturizer in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending 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. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the risk of teratogenic effects associated with its use. Pregnant women should avoid the use of this product and are advised to consult a healthcare provider for guidance regarding alternative treatment options.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should initiate supportive care, 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. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose cases, as these may vary based on the specific circumstances and the substance involved.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective management 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 these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert for CETAPHIL GENTLE CLEAR MATTIFYING ACNE MOISTURIZER.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Users should be aware that the product should be discarded after opening if it is not utilized within a specified time frame, although this time frame is not detailed in the provided information.

Additional Clinical Information

The product is administered topically. For new users, it is recommended to apply the product sparingly to one or two small affected areas during the first three days to assess for any discomfort. Patients should ensure the skin is thoroughly cleaned before application. A thin layer should be applied to the entire affected area one to three times daily. To minimize the risk of excessive skin drying, it is advisable to start with one application daily, gradually increasing to two or three times daily as needed or directed by a clinician. If bothersome dryness or peeling occurs, patients should reduce the frequency of application to once a day or every other day.

Drug Information (PDF)

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

View product document (PDF)