Zo Skin Health Retinol Plus Acne Complex

Description

ZO® Skin Health is a product developed by Zein Obagi, MD, designed to address skin concerns associated with acne. The formulation includes a proprietary Retinol + Acne Complex, which is intended to promote skin renewal and improve the appearance of acne-prone skin. Each container holds 50 mL (1.7 Fl. Oz.) of the product.

The product is distributed by ZO Skin Health, Inc., located in Irvine, California, and is manufactured in the USA using both domestic and imported materials. The National Drug Code (NDC) for this product is 42851-093-50. For further information, visit zoskinhealth.com.

Uses and Indications

This drug is indicated for the management of acne. It penetrates the pores to control existing acne blemishes and helps prevent the formation of new acne blemishes.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 following dosing instructions may be implemented.

Prior to application, the skin should be cleaned thoroughly. The product should then be applied as a thin layer to the entire affected area. The recommended frequency of application is one to three times daily. To minimize the risk of excessive drying of the skin, it is advisable to start with one application per day. Based on individual tolerance and as directed by a healthcare professional, the frequency may be gradually increased to two or three times daily.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the frequency of application to once a day or every other day.

Contraindications

Use is contraindicated in patients who experience irritation or worsening of symptoms upon administration.

Warnings and Precautions

For external use only.

Skin irritation and dryness may be exacerbated when used concurrently with other topical acne medications. It is advised that healthcare professionals recommend the use of only one topical acne treatment at a time to minimize the risk of irritation.

Patients should be instructed to discontinue use and consult a healthcare provider if any irritation occurs or worsens during treatment.

In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only. The most common adverse reactions reported include skin irritation and dryness, particularly when used concurrently with other topical acne medications. If patients experience irritation, it is advised to discontinue use and consult a healthcare professional.

In the event that irritation worsens, patients should stop using the product and seek medical advice. Additionally, it is crucial to keep this product out of reach of children. If ingested, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 additional topical agents 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 Zo Skin Health Retinol Plus Acne Complex (salicylic acid). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be monitored closely when using this product. 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.

For new users, a sensitivity test is recommended. The product should be applied sparingly to one or two small affected areas during the first three days. If no discomfort occurs, patients may proceed with the full application as directed.

To minimize the risk of excessive skin drying, it is advised to start with one application daily. Depending on the patient's response, the frequency may be gradually increased to two or three times daily, or as directed by a healthcare professional. Should bothersome dryness or peeling develop, 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 ZO Skin Health Retinol Plus Acne Complex in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for adverse effects may be prudent in this population, given the lack of established guidelines for geriatric use.

Pregnancy

The product is contraindicated in pregnancy due to potential risks to the fetus associated with its use. Healthcare professionals should advise pregnant patients against the use of this product, as it may pose significant risks to fetal outcomes. Women of childbearing potential should be informed of these risks and advised to use effective contraception during treatment to prevent exposure during pregnancy.

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

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 relation to this medication. 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 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 may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous evaluation and appropriate interventions should be implemented based on the clinical presentation and severity of symptoms.

In all cases of suspected overdosage, the involvement of poison control and emergency medical services is recommended to ensure optimal patient care and safety.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if they experience any irritation that occurs or worsens during treatment. It is important to note that the likelihood of skin irritation and dryness may increase if patients use another topical acne medication concurrently. Therefore, healthcare providers should recommend that patients use only one topical acne medication at a time to minimize the risk of irritation.

Storage and Handling

This product is supplied in packaging that ensures its integrity during storage and handling. It is essential to protect the product from excessive heat and direct sunlight to maintain its efficacy and safety.

For optimal storage conditions, it is recommended to keep the product in a cool, dry place, away from sources of heat and light. Proper handling practices should be observed to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Zo Skin Health Retinol Plus Acne Complex, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)