Stridex

Description

NDC 10157-1007-2 identifies a topical acne treatment formulated with Stridex® Salicylic Acid at a concentration of 0.5% w/w. This product is designed for single-step acne control and is alcohol-free, making it suitable for sensitive skin. Each package contains 90 soft touch pads, which are infused with aloe to provide additional soothing properties during application.

Uses and Indications

This drug is indicated for the treatment and management of acne. It reduces the number of acne pimples and blackheads, facilitating the healing of the skin. Additionally, this drug helps to prevent the formation of new acne pimples.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed prior to the application of the medication. The medication should be applied using a pad to wipe the entire affected area. If necessary, a clean pad may be used to remove any remaining traces of dirt.

Initial treatment should consist of one application daily. Based on the patient's response and as directed by a physician, the frequency may be gradually increased to two to three times daily. In cases where bothersome dryness or peeling occurs, it is advisable to reduce the application frequency to once daily or every other day.

It is important to avoid leaving the pad on the skin for an extended period. Additionally, care should be taken to keep the medication away from the eyes, lips, and other mucous membranes.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to salicylic acid.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients not to use this product if they have a known allergy to salicylic acid, as this could lead to serious adverse reactions.

Concurrent use of other topical acne medications may exacerbate skin dryness or irritation. In such cases, it is recommended that only one medication be utilized unless otherwise directed by a healthcare provider. Monitoring for signs of increased skin irritation is advised.

To ensure safety, this product should be kept 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.

Side Effects

Patients should be aware that this product is for external use only. It is important to note that individuals with a known allergy to salicylic acid should not use this product due to the potential for serious allergic reactions.

During the use of this product, patients may experience increased dryness or irritation of the skin, particularly if they are using other topical acne medications concurrently or immediately following application. In such cases, it is advised that only one medication be used unless directed by a healthcare professional.

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

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 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 Stridex (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this medication. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

To minimize the risk of excessive skin drying, treatment should begin with one application daily. The frequency may be gradually increased to two to three times daily as needed or as directed by a healthcare professional. If patients experience bothersome dryness or peeling, the application frequency should be reduced to once a day or every other day.

Geriatric Use

There is no specific information regarding the use of Stridex Sensitive (salicylic acid liquid) in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

The safety of salicylic acid during pregnancy has not been established. Salicylic acid is contraindicated in pregnancy due to potential risks to the fetus, including the possibility of teratogenic effects when used during this period. Women of childbearing potential should consult a healthcare provider before using this product if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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

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 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 use of the compound in these contexts.

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. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use this product if they have a known allergy to salicylic acid, as this could lead to serious allergic reactions.

Additionally, healthcare providers should discuss the potential for increased dryness or irritation of the skin when using this product in conjunction with other topical acne medications. Patients should be instructed to use only one medication at a time unless otherwise directed by a healthcare professional.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should counsel patients on important safety measures, including the necessity to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is crucial to keep the product out of reach of children.

Patients are advised to start with one application daily to minimize the risk of excessive skin drying, gradually increasing to two to three times daily as needed or directed by a healthcare provider. If patients experience bothersome dryness or peeling, they should reduce the frequency of application to once a day or every other day. Additionally, patients should avoid leaving the pad on the skin for extended periods and ensure that the product does not come into contact with the eyes, lips, or other mucous membranes.

Drug Information (PDF)

This file contains official product information for Stridex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)