Cetaphil Gentle Clear Clarifying Acne Cleanser

Description

Cetaphil Gentle Clear Clarifying Acne Cream Cleanser is formulated with 2% salicylic acid, serving as an effective acne treatment. This cleanser is designed to deep clean and exfoliate the skin, aiding in the unclogging of pores to prevent future breakouts. The formulation includes salicylic acid, white tea, and aloe, which contribute to its efficacy and soothing properties. It is dermatologist recommended and is suitable for sensitive skin, as indicated by the sensitive skin logo. The product is available in a 4.2 FL OZ (124 mL) container.

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

The product should be applied to dampened skin, ensuring to gently massage the formulation into the skin while avoiding the eye area. After application, it is essential to rinse the skin thoroughly and pat it dry.

The recommended usage frequency is twice daily. However, if signs of dryness occur, the frequency of application may be reduced as needed.

Contraindications

Use is contraindicated in the following situations:

• Keep out of reach of children to prevent accidental ingestion or misuse.

• Discontinue use and consult a healthcare professional if irritation becomes severe, as this may indicate an adverse reaction.

• Avoid contact with eyes; in the event of contact, rinse eyes thoroughly with water to mitigate potential irritation.

Warnings and Precautions

For external use only. Caution is advised when using this product, as skin irritation and dryness may be exacerbated if another topical acne medication is applied concurrently. In the event of irritation, it is recommended to limit the use to one topical acne treatment at a time to minimize adverse effects.

Care should be taken to avoid contact with the eyes. Should contact occur, it is imperative to rinse the eyes thoroughly with water to prevent potential damage.

If irritation becomes severe, it is essential to discontinue use and consult a healthcare professional for further evaluation and guidance.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised without delay.

Side Effects

Patients using this product should be aware that it is for external use only. Common adverse reactions include skin irritation and dryness, which are more likely to occur if another topical acne medication is used concurrently. In such cases, it is advised to use only one topical acne treatment 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 stop use and consult a healthcare professional.

Additionally, this product should be kept out of reach of children. If swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 advisable to limit the use of topical acne treatments to one at a time. If irritation occurs, the patient should discontinue the use of additional topical agents and focus on a single treatment to allow the skin to recover. Monitoring for signs of irritation is recommended when initiating or adjusting treatment regimens involving topical acne medications.

Packaging & NDC

Below are the non-prescription pack sizes of Cetaphil Gentle Clear Clarifying Acne Cleanser (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 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

The product has not been evaluated for safety in pregnancy. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus. The use of salicylic acid during pregnancy may pose significant risks, and it is advised that pregnant patients consult a healthcare provider before use. No specific dosage modifications for pregnant individuals are provided; however, caution is advised. Pregnant women should avoid using this product unless directed by a healthcare professional.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

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

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

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, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience severe irritation. It is important to discuss that skin irritation and dryness may be more pronounced if they are using another topical acne medication concurrently. Therefore, patients should be encouraged to use only one topical acne treatment at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes. In case of accidental contact, patients should rinse their eyes thoroughly with water to alleviate any discomfort.

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 a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is intended for topical administration and is designed for use twice daily, although patients may apply it less frequently if dryness occurs. Clinicians should advise patients that the product is for external use only and that the likelihood of skin irritation and dryness increases when used concurrently with other topical acne medications. If irritation arises, it is recommended to limit use to one topical acne treatment at a time.

Patients should be cautioned to avoid contact with the eyes; in the event of contact, they should rinse their eyes thoroughly with water. If severe irritation develops, patients are advised to discontinue use and consult a healthcare professional. Additionally, the product should be kept out of reach of children, and in cases of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)