Retinol Clearing

Description

Retinol is the active ingredient in this professional-grade skin care formulation, presented as a clearing oil. The product is packaged in a volume of 1 US fluid ounce (30 mL ℮) and is branded under Dermalogica. It is manufactured by The International Dermal Institute.

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

Healthcare professionals are advised to ensure that the skin is thoroughly cleaned prior to the application of this product.

For nighttime use, after cleansing the skin, the healthcare professional should instruct the patient to gently press the button on the dropper to dispense 6 to 10 drops into their hands. The patient should then smooth the product evenly over the face and neck.

In cases where the patient experiences bothersome dryness or peeling, it is recommended to reduce the frequency of application to once daily or every other day, depending on the severity of the symptoms.

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 or contact with a Poison Control Center is required.

Warnings and Precautions

This product is intended for external use only. It contains Retinol, a derivative of Vitamin A, which may cause skin irritation in some individuals. Therefore, it is essential for healthcare professionals to advise patients to consult a physician prior to use if they are pregnant or breastfeeding.

Care should be taken to avoid contact with the eyes. In the event of accidental contact, it is crucial to flush the eyes thoroughly with water to mitigate any potential irritation. Additionally, patients should be instructed to use sunscreen and limit sun exposure while using this product, as Retinol can increase skin sensitivity to sunlight.

It is important to note that this product should not be used concurrently with other products containing Retinol, as this may lead to increased risk of adverse effects. Furthermore, this product must be kept out of reach of children to prevent accidental ingestion. In the case of swallowing the product, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients using this product should be aware that it is for external use only and contains Retinol, a form of Vitamin A. It is advised that individuals who are pregnant or breastfeeding consult a physician prior to use. Care should be taken to avoid contact with the eyes; in the event of contact, the eyes should be flushed thoroughly with water. Additionally, patients are encouraged to use sunscreen and limit sun exposure while using this product. It is important to note that this product should not be used in conjunction with other products containing Retinol.

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

Drug Interactions

The concurrent use of topical acne medications may increase the risk of skin irritation and dryness. It is advisable to limit the use to one topical acne medication at a time to mitigate these effects.

Additionally, the use of products containing Retinol alongside this medication is contraindicated. Co-administration may exacerbate skin irritation and should be avoided to ensure optimal tolerability and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Retinol Clearing (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 Retinol Clearing Oil 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

Pregnant patients and those who are breastfeeding should consult a physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure optimal fetal outcomes.

Lactation

Lactating mothers are advised to consult a physician prior to using this medication. There is no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should consider the potential risks and benefits when recommending this medication to lactating patients.

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 hepatic impairment, including dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise caution and consider individual patient circumstances when prescribing this medication to patients with liver problems.

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 experts is recommended to guide the management and ensure the best possible care for the patient.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a physician prior to use. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 about the importance of cleaning the skin thoroughly before applying the product to ensure optimal effectiveness. It is also essential to discuss the potential for skin irritation and dryness, particularly if patients are using another topical acne medication concurrently. If irritation occurs, patients should be advised to limit their use to one topical acne medication at a time.

When instructing patients on the application process, they should be guided to press the button and release to fill the dropper. At night, after cleansing, patients should gently press the button to dispense 6-10 drops into their hands and smooth the product over their face and neck.

Additionally, healthcare providers should inform patients that if they experience bothersome dryness or peeling, they may need to reduce the application frequency to once a day or every other day to minimize these side effects.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the product from light exposure to maintain its integrity. The bottle should be kept tightly closed when not in use to prevent contamination and degradation. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. Clinicians should advise patients who are pregnant or breastfeeding to consult a physician before use. Patients are also cautioned to avoid contact with the eyes; in the event of contact, they should flush the eyes thoroughly with water. It is recommended that patients use sunscreen and limit sun exposure while using this product.

Additionally, patients should be aware that using another topical acne medication concurrently may increase the likelihood of skin irritation and dryness. If such irritation occurs, it is advisable to use only one topical acne medication at a time. Should bothersome dryness or peeling develop, patients may reduce the frequency of application to once a day or every other day.

Drug Information (PDF)

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

View product document (PDF)