Biore

Description

Biore Blemish Fighting Ice 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. There are no teratogenic or nonteratogenic effects mentioned associated with its use.

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 patient should rinse the face thoroughly with water.

For optimal results, it is recommended that this regimen be performed daily.

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. It is imperative that this product is not ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

General precautions must be observed to ensure safety. This product should be kept out of 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.

No specific instructions for discontinuation of use and consultation with a healthcare provider are provided in the insert. However, healthcare professionals should remain vigilant and monitor for any adverse reactions or complications associated with the use of this product.

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 of these reactions was 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 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 contact with a Poison Control Center is recommended.

Geriatric Use

There is no specific information available 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.

Pregnancy

The safety of this product during pregnancy has not been established, as there are no specific data regarding its use in pregnant patients. Consequently, healthcare professionals should exercise caution when prescribing this product to women who are pregnant or may become pregnant. Given the absence of safety information, the potential risks to fetal outcomes remain unknown. It is advisable for healthcare providers to weigh the benefits against any potential risks when considering treatment options for pregnant patients.

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 concerns have been identified in the available information.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 insert text.

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 discussing the use of this product, healthcare providers should inform patients that skin irritation and dryness may be more likely to occur if they are using another topical acne medication concurrently. It is recommended that patients use only one topical acne medication at a time to minimize the risk of irritation.

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.

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.

Additional Clinical Information

The medication is administered topically, with daily use recommended for optimal results. Clinicians should counsel patients on the potential for skin irritation and dryness, particularly if another topical acne medication is used concurrently; it is advised to use only one topical acne treatment at a time to minimize irritation. Patients should also be instructed to avoid contact with the eyes, and in the event of contact, to rinse thoroughly with water. Additionally, the medication should be kept out of reach of children, and if swallowed, medical assistance or contact with a Poison Control Center should be sought immediately.

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)