Biore

Description

Biore Witch Hazel Pore Clarifying Cooling Cleanser is an oil-free formulation designed for acne treatment, featuring salicylic acid as its active ingredient. The product is presented in a liquid dosage form, with a volume of 6.77 fluid ounces (200 mL).

Uses and Indications

This drug is indicated for the treatment of acne vulgaris. It effectively clears existing acne blemishes and penetrates pores to control the formation of acne lesions. Additionally, this drug helps prevent the emergence of new acne blemishes.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals are advised to instruct patients to begin by wetting the face. Following this, the product should be pumped into the hands and then massaged gently over the entire face and neck. It is essential to ensure that the product is applied evenly. After massaging, the face and neck should be rinsed thoroughly with water. For optimal results, it is recommended that this regimen be performed daily.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the following precautions:

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

• In the event of accidental swallowing, seek medical assistance or contact a Poison Control Center immediately.

• Avoid contact with eyes; if contact occurs, rinse thoroughly with water to mitigate potential irritation.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

General precautions must be observed to ensure safety. This product should be kept out of the reach of children to prevent accidental ingestion. If swallowed, it is crucial to obtain medical help promptly or reach out to a Poison Control Center for guidance.

Healthcare professionals should advise patients to stop using the product and seek medical attention if any adverse reactions occur, although specific conditions for discontinuation are not provided in the insert.

Side Effects

Patients should be aware that the product is intended for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

It is essential for patients to monitor for any unexpected effects and to consult healthcare professionals if they experience any adverse reactions while using the product.

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 should be considered to alleviate symptoms. Monitoring for signs of skin irritation is recommended when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Biore (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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The available data regarding the use of this product during pregnancy is limited, as no specific information is provided in the drug insert. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding use during pregnancy are mentioned. Healthcare professionals should consider the lack of data when prescribing this product to pregnant patients and weigh the potential benefits against any unknown risks. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

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

When using this product, it is important to inform patients that skin irritation and dryness may be more likely to occur if they are using another topical acne medication concurrently. Therefore, if irritation develops, patients should be counseled to use only one topical acne medication at a time to minimize the risk of adverse effects.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes. In the event of accidental contact, patients should be instructed to rinse their eyes thoroughly with water to alleviate any potential discomfort.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available 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 for optimal results, with a recommended frequency of daily use. 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 Biore, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)