Neutralyze Clearing Serum

Description

neutralyze® NEUTRALYZE CLEARING SERUM is a skin repairing and acne treatment gel indicated for the second step of the neutralyze regimen. This formulation is designed to clear acne, fade dark spots, and correct uneven skin tone. It also provides additional benefits by controlling oil, unclogging pores, and reducing their size. The product is available in a volume of 1.52 fluid ounces (45 mL).

Uses and Indications

This drug is indicated for the treatment of acne.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For new users, it is recommended to perform a sensitivity test by applying the product sparingly to one or two small affected areas for the first three days. If no discomfort is experienced, the user may proceed to cover the entire affected area with a thin layer of the product. This application should be done one to three times daily, as needed or as directed by a healthcare professional.

The product should not be rinsed off after application. It is advisable to start with one application per day, gradually increasing to two to three times daily based on individual tolerance and clinical response. In cases where bothersome dryness, peeling, or irritation occurs, the frequency of application should be reduced to once a day or every other day.

Contraindications

Use of this product is contraindicated in individuals with very sensitive skin or those with a known sensitivity to salicylic acid. Due to the potential for severe irritation, discontinue use and consult a healthcare professional if irritation becomes severe. Additionally, avoid contact with eyes; in the event of contact, rinse thoroughly with water. It is also advised to limit unnecessary sun exposure and to apply a sunscreen with an SPF of 15 or higher while using this product.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients that the likelihood of skin irritation and dryness may increase if another topical acne medication is used concurrently. It is recommended that patients use only one topical acne medication at a time unless otherwise directed by a healthcare provider.

Patients should be cautioned to avoid contact with the eyes. In the event of accidental contact, they should rinse their eyes thoroughly with water. Additionally, patients are advised to minimize unnecessary sun exposure and to apply a sunscreen with an SPF of 15 or higher to protect the skin.

This product should not be used by individuals with very sensitive skin or those who have a known sensitivity to salicylic acid. If patients experience severe irritation, they should discontinue use and consult a healthcare professional for further guidance.

It is imperative to keep this product out of reach of children. In the case of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product may experience skin irritation and dryness, particularly if they concurrently use another topical acne medication. It is advised that only one topical acne medication be used at a time unless directed by a healthcare professional to minimize the risk of irritation.

In the event of eye contact, patients should rinse their eyes thoroughly with water. Additionally, patients are cautioned to avoid unnecessary sun exposure and to use a sunscreen with an SPF of 15 or higher to protect their skin.

This product is for external use only and should not be used by individuals with very sensitive skin or those who are known to be sensitive to salicylic acid.

Patients are advised to discontinue use and consult a doctor if irritation becomes severe. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Drug Interactions

The concurrent use of this product with other topical acne medications may increase the risk of skin irritation and dryness. It is advised that only one topical acne medication be used at a time to minimize the potential for irritation, unless otherwise directed by a healthcare professional. Monitoring for signs of skin irritation is recommended, and dosage adjustments should be considered based on the severity of any adverse effects experienced.

Packaging & NDC

Below are the non-prescription pack sizes of Neutralyze Clearing Serum (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 NEUTRALYZE CLEARING SERUM in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to initiating treatment.

Pregnancy

There is no information available regarding the use of NEUTRALYZE CLEARING SERUM (salicylic acid gel) during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this product to pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 prescribing information.

Overdosage

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

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and monitoring for any signs of toxicity is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers assess the patient's condition thoroughly and initiate appropriate interventions based on the clinical presentation.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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.

Patients should be informed not to use the product if they have very sensitive skin or a known sensitivity to salicylic acid. It is important to counsel patients to stop using the product and consult a doctor if they experience severe irritation.

When using this product, patients should be made aware that skin irritation and dryness may be more likely to occur if they are using another topical acne medication simultaneously. They should be advised to use only one topical acne medication at a time unless directed otherwise by a healthcare professional. Additionally, patients should be cautioned to avoid contact with the eyes; if contact occurs, they should rinse their eyes thoroughly with water.

Finally, healthcare providers should recommend that patients avoid unnecessary sun exposure while using this product and to apply a sunscreen with an SPF of 15 or higher to protect their skin.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. For new users, it is recommended to conduct a sensitivity test by applying the product sparingly to one or two small affected areas during the first three days. If no discomfort is experienced, patients should then cover the entire affected area with a thin layer one to three times daily without rinsing off. To minimize the risk of excessive drying or skin irritation, it is advised to start with one application daily, gradually increasing to two to three times daily as needed or directed by a clinician. Should bothersome dryness, peeling, or irritation occur, patients should reduce the application frequency to once a day or every other day.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)