Biore

Description

Biore Witch Hazel Pore Clarifying Toner is a lightweight, 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 net weight of 8.0 fluid ounces (236 mL).

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed prior to the application of the medication. The affected area should be covered with a thin layer of the medication, applied 1 to 3 times daily using a cotton ball or pad.

It is recommended to initiate treatment with one application per day to minimize the risk of excessive drying of the skin. Based on the patient's response and as directed by a physician, the frequency of application may be gradually increased to 2 or 3 times daily.

In cases where bothersome dryness or peeling occurs, it is advisable to reduce the frequency of application to once daily or every other day to alleviate these symptoms.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

• Contact with eyes should be avoided; if contact occurs, the eyes must be rinsed thoroughly with water.

Warnings and Precautions

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

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is crucial to ensure the safety and well-being of the patient.

No additional general precautions or laboratory tests are specified in the insert. Healthcare professionals should remain vigilant and exercise clinical judgment when advising patients on the use of this product.

Side Effects

Patients should be aware that the product is for external use only. It is important to note that the product is flammable; therefore, it should be kept away from fire or flame to prevent any potential hazards.

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 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

There is no specific information regarding the use of Biore Witch Hazel Pore Clarifying Toner in geriatric patients. The drug insert does not provide details on dosage adjustments, safety concerns, or special precautions that may be necessary 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 the patient's response to the product.

Pregnancy

There is no information available regarding the use of Biore Witch Hazel Pore Clarifying Toner during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data when assessing its use in this population.

Lactation

There is no information available regarding the use of Biore Witch Hazel Pore Clarifying Toner in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider this lack of data when advising lactating patients.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, no dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function are specified in the prescribing information. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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 compound in these areas.

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 assistance 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 instructed 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. Instruct patients that if contact occurs, they should 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 noted, ensuring straightforward management within standard storage conditions.

Additional Clinical Information

The route of administration for the product is topical. There is no additional information available regarding laboratory tests, abuse potential, 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)