Pharma Clear Cleanser

Description

The product is identified by the SPL code 34089-3 and is associated with the reference image file PHK_1A_RL-2_2.jpg, which is in JPEG format. The media type for this product is image/jpeg.

Uses and Indications

This drug is indicated for the treatment of acne and for the reduction of bacteria on the skin. It is intended for use in patients diagnosed with acne vulgaris, aiming to improve skin condition and reduce the presence of acne-causing bacteria.

Dosage and Administration

The product should be applied to a wet area. Healthcare professionals should instruct patients to dispense an appropriate amount of the product into their hands and gently massage it onto the face and body, taking care to avoid the eye area. After application, it is essential to rinse thoroughly with warm water and pat the skin dry. For optimal results, the product is recommended for use twice daily.

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is required.

• Contact with the eyes must be avoided. If exposure occurs, the eyes should be rinsed thoroughly with water.

• Concurrent use with other topical acne medications may lead to increased dryness or irritation of the skin. In such cases, only one medication should be utilized unless otherwise directed by a healthcare professional.

• The product is intended for use only on the face and neck; application to other areas is not recommended.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Care should be taken to avoid contact with the eyes. Should the product inadvertently enter the eyes, it is essential to rinse thoroughly with water to mitigate potential irritation.

Concurrent use of other topical acne medications may exacerbate skin dryness or irritation. In such cases, it is advised that only one medication be utilized unless otherwise directed by a healthcare professional.

The application of this product should be limited to the face and neck to ensure safety and efficacy.

Side Effects

Patients should be advised that the product is for external use only. This warning is critical to ensure safe and appropriate use, as improper application may lead to adverse effects not specified in the labeling. No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

Drug Interactions

Concurrent use of other topical acne medications may lead to increased dryness or irritation of the skin when used simultaneously or immediately after the application of this product. In such cases, it is advisable to limit the use to one topical acne medication unless otherwise directed by a healthcare professional. Monitoring for signs of excessive dryness or irritation is recommended to ensure patient comfort and skin health.

Packaging & NDC

Below are the non-prescription pack sizes of Pharma Clear 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, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of salicylic acid 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. Therefore, pregnant women should avoid using products containing salicylic acid to mitigate any potential harm to fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding these risks and to consider alternative treatments that are deemed safer during pregnancy.

Lactation

There is no specific information regarding the use of Pharma Clear Cleanser (salicylic acid gel) in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers. The effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Prior to initiating therapy, renal function tests should be performed, and these tests should be conducted periodically thereafter to ensure ongoing safety and efficacy. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with treatment.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of exposure, is crucial for effective management and treatment planning.

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 product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned to avoid contact with the eyes. If the product inadvertently gets into the eyes, they should rinse thoroughly with water.

It is important to inform patients that using other topical acne medications concurrently or immediately after applying this product may lead to increased dryness or irritation of the skin. In such cases, patients should be advised to use only one medication unless directed otherwise by a healthcare professional.

Additionally, patients should be instructed to limit the use of the product to the face and neck to minimize the risk of adverse effects.

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 product is administered topically, with optimal results achieved through twice-daily application. Clinicians should advise patients to avoid contact with the eyes; in the event of contact, thorough rinsing with water is recommended. Patients should also be cautioned against using other topical acne medications concurrently or immediately after application, as this may exacerbate skin dryness or irritation. If such reactions occur, it is advisable to limit the use to one medication unless otherwise directed by a healthcare professional. Additionally, the use of the product should be restricted to the face and neck areas.

Drug Information (PDF)

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

View product document (PDF)