Clean and Clear Acne Spot Treatment

Description

Clean & Clear® acne spot treatment contains salicylic acid as its active ingredient, formulated to deliver clinically proven results within one day. This treatment incorporates witch hazel, enhancing its efficacy. The product is characterized by being both fragrance-free and oil-free, making it suitable for various skin types. It is available in a volume of 0.75 fluid ounces (22 mL).

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 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.

It is advisable to initiate treatment with one application per day to minimize the risk of excessive drying of the skin. Based on the patient's response, the frequency may be gradually increased to two or three times daily as necessary. Should the patient experience bothersome dryness or peeling, the application frequency should be reduced to once a day or every other day to alleviate these symptoms.

Contraindications

There are no specific contraindications listed for this product. However, the following precautions should be observed:

• Keep out of reach of children. In the event of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately.

• Avoid contact with eyes. If contact occurs, flush the eyes with water immediately.

• The use of this product concurrently with other topical acne medications may increase the risk of skin irritation and dryness. It is recommended to use only one topical acne medication at a time to minimize the potential for irritation.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from open fire or flame to prevent any risk of ignition.

Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental contact, it is imperative to immediately flush the eyes with water to mitigate potential irritation.

The concurrent use of this product with other topical acne medications may increase the likelihood of skin irritation and dryness. It is recommended that patients use only one topical acne medication at a time to minimize the risk of adverse skin reactions.

This product should be stored out of reach of children. In cases of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only and is flammable; therefore, it should be kept away from open fire or flame.

In clinical practice, participants have reported skin irritation and dryness, particularly when this product is used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately. Additionally, care should be taken to avoid contact with the eyes; if contact occurs, it is imperative to flush the eyes with water immediately.

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 Clean and Clear Acne Spot Treatment (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

For topical application, it is recommended to initiate treatment with one application daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two or three times daily as needed or as directed by a healthcare professional. Should patients experience bothersome dryness or peeling, the frequency of application should be reduced to once a day or every other day.

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

There is no specific information available regarding the use of Clean & Clear Acne Spot Treatment (salicylic acid gel) during pregnancy. As such, the safety of this product in pregnant patients has not been established. There are no known dosage modifications or special precautions indicated for use during pregnancy. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks versus benefits of treatment. It is recommended that pregnant patients consult their healthcare provider before using this product.

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

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided.

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 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 limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Patients should be informed to avoid contact with their eyes. If contact occurs, they should immediately flush the eyes with water to minimize irritation.

It is important to discuss the potential for skin irritation and dryness, particularly if patients are using another topical acne medication concurrently. Healthcare providers should recommend that if irritation occurs, patients should limit their use to one topical acne medication at a time to reduce the risk of adverse effects.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

The product 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 daily and may gradually increase to two or three times daily as needed or as directed by a healthcare professional.

Clinicians should counsel patients to avoid contact with the eyes, flushing with water immediately if contact occurs. Concurrent use of other topical acne medications may increase the likelihood of skin irritation and dryness; therefore, it is advised to use only one topical acne medication at a time if irritation develops. Additionally, the product contains an alpha hydroxy acid (AHA), which can heighten skin sensitivity to sunlight, increasing the risk of sunburn. Patients should be advised to use sunscreen, wear protective clothing, and limit sun exposure during treatment and for one week following discontinuation.

Drug Information (PDF)

This file contains official product information for Clean and Clear Acne Spot Treatment, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)