Biore

Description

Biore Pore Unclogging Scrub is an oil-free acne treatment formulated with salicylic acid, designed to deep clean pores and smooth the skin. The product is presented in a net weight of 5.0 ounces (141 grams).

Uses and Indications

This drug is indicated for the treatment of acne vulgaris, specifically targeting the control of acne blemishes and blackheads through its ability to penetrate pores effectively.

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 thoroughly. Following this, the product should be squeezed into the hands and then massaged gently over the entire face. It is essential to ensure that the product is evenly distributed during the massage. After the application, the face must be rinsed thoroughly with water to remove any residue.

For optimal results, it is recommended that this regimen be followed 2 to 3 times per week.

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 flushed thoroughly with water.

Warnings and Precautions

For external use only. The concurrent use of other topical acne medications may exacerbate skin dryness or irritation. In such cases, it is advised to limit the use to one medication unless otherwise directed by a healthcare professional.

General precautions should be observed, including keeping the 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.

Emergency medical help should be obtained if the product is swallowed. Prompt action is crucial in such situations to ensure safety and appropriate care.

Healthcare professionals are encouraged to monitor patients for any signs of excessive dryness or irritation and to provide guidance on the appropriate use of this product in conjunction with other acne treatments.

Side Effects

Patients should be aware that this product is for external use only. The concurrent use of other topical acne medications, either simultaneously or immediately following the application of this product, may lead to increased dryness or irritation of the skin. In such cases, it is advised that only one medication be utilized unless directed otherwise by a healthcare professional.

Drug Interactions

Concurrent use of other topical acne medications with this product may lead to increased dryness or irritation of the skin. In such cases, it is advisable to limit the use to one medication at a time 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 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 contact with a Poison Control Center is recommended.

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.

Lactation

There is no specific information regarding the use of this drug in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to nursing mothers, as the effects on breastfed infants are not established.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 available in the provided text.

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.

Additionally, it is important to instruct patients to avoid contact with the eyes while using this product. Should contact occur, they should flush the eyes thoroughly with water to minimize any potential irritation or harm.

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; however, standard precautions should be observed to ensure optimal storage conditions.

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)