111medco 2% Salicylic Acid Cleansing Bar

Description

111MedCo 2% Salicylic Acid Cleansing Bar contains 2% salicylic acid as its active ingredient. This formulation is presented in the form of a cleansing bar, designed for topical application. The product has a net weight of 4 ounces (113 grams) and is identified by the SPL code 34089-3.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively reduces the number of acne pimples and facilitates the healing of the skin. The formulation penetrates pores to clear existing acne blemishes and dries up acne pimples. Additionally, it aids in maintaining clear skin by preventing the formation of new acne blemishes, including whiteheads and blackheads.

Dosage and Administration

Healthcare professionals are advised to apply the medication liberally over wet skin using a clean washcloth or body puff, with particular focus on areas prone to acne while avoiding contact with the eyes. Following application, the product should be rinsed thoroughly, and the skin should be patted dry with a clean towel.

Initial treatment should commence with one application daily. Based on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily as necessary. In cases where the patient experiences bothersome drying or peeling, it is recommended to reduce the application frequency to once a day or every other day.

Contraindications

Use of this product is contraindicated in the following situations:

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

Additionally, the concurrent use of multiple topical acne medications is contraindicated unless specifically directed by a healthcare provider to avoid potential adverse effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid concurrent use of this product with other topical acne medications, as this may lead to skin irritation and dryness. If such reactions occur, patients should be instructed to use only one medication at a time unless otherwise directed by a healthcare provider.

In the event of accidental ingestion, it is imperative to seek medical assistance immediately or contact a Poison Control Center for guidance.

Side Effects

Patients using this product should be aware that it is for external use only. The application of this product may lead to skin irritation and dryness, particularly if used concurrently with other topical acne medications or immediately following their use. In such cases, it is advisable to use only one medication at a time unless otherwise directed by a healthcare provider.

Additionally, it is crucial to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

Concurrent use of this product with other topical acne medications may lead to skin irritation and dryness. It is advisable to apply only one topical acne treatment at a time to minimize the risk of adverse effects, unless otherwise directed by a healthcare provider. Monitoring for signs of skin irritation is recommended, and dosage adjustments should be considered based on the severity of any adverse reactions.

Packaging & NDC

Below are the non-prescription pack sizes of 111medco 2% Salicylic Acid Cleansing Bar (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 111MedCo 2% Salicylic Acid Cleansing Bar in geriatric patients. The prescribing information 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 treatment outcomes in this population.

Pregnancy

There is currently no information available regarding the use of 111MedCo 2% Salicylic Acid Cleansing Bar during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when recommending this product to pregnant patients.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for 111MedCo 2% Salicylic Acid Cleansing Bar. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk are not established. Healthcare professionals should exercise caution when recommending this product to lactating mothers.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data does not preclude the need for careful assessment and monitoring based on individual patient circumstances.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to address any complications that may arise.

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

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand the potential for skin irritation and dryness when using this product in conjunction with other topical acne medications. Healthcare providers should emphasize the necessity of using only one medication at a time unless otherwise directed by a healthcare professional. This guidance is crucial to minimize the risk of adverse skin reactions.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product at room temperature to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light exposure. Additionally, it is crucial to keep the container tightly closed when not in use to prevent contamination and degradation. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients that the concurrent use of this product with other topical acne medications may lead to skin irritation and dryness. It is advisable for patients to use only one medication at a time unless otherwise directed by a healthcare provider.

To mitigate the risk of bothersome dryness, patients are encouraged to start with one application daily, gradually increasing to two or three times daily as needed. If significant drying or peeling occurs, patients should reduce the frequency of application to once a day or every other day.

Drug Information (PDF)

This file contains official product information for 111medco 2% Salicylic Acid Cleansing Bar, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)