Glytone Acne Clearing Toner

Description

GLYTONE is an acne clearing toner formulated for acne therapy. It contains 2% salicylic acid, a recognized acne medication, and niacinamide, known for its skin-soothing properties. The product is available in a 200 mL (6.76 FL. OZ.) dosage form.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively dries and clears acne blemishes, facilitating the healing process of the skin. The formulation penetrates pores to eliminate most acne blemishes, including blackheads and whiteheads, and aids in the prevention of new acne blemishes, blackheads, and whiteheads.

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

Dosage and Administration

After cleansing the skin, the toner should be applied to a cotton pad and gently applied to the affected area. This application may be performed one to three times daily, based on individual needs or as directed by a healthcare professional. It is important to note that the toner should not be rinsed off after application.

For initial use, it is recommended to start with one application per day. Depending on the patient's response and tolerance, the frequency may be gradually increased to two or three times daily. In cases where bothersome dryness or peeling occurs, the application frequency should be reduced to once a day or every other day to minimize irritation.

Contraindications

Use is contraindicated in the following situations:

• Keep out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, seek medical assistance or contact a Poison Control Center immediately.

• Discontinue use and consult a healthcare professional if a rash develops.

• Avoid contact with eyes; in case of eye contact, rinse thoroughly with water.

Warnings and Precautions

For external use only. This product is flammable; therefore, it must be kept away from fire or flame to prevent any risk of ignition.

In the event of a rash occurring during use, it is imperative to discontinue use immediately and consult a healthcare professional for further evaluation and guidance.

If the product is ingested, it is crucial to seek medical assistance or contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients using this product should be aware that it is for external use only and is flammable; therefore, it should be kept away from fire or flame.

During clinical use, skin irritation and dryness have been reported, particularly when this product is used concurrently with other topical acne medications. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time. Additionally, contact with the eyes should be avoided; in the event of eye contact, patients should rinse thoroughly with water.

Patients are instructed to discontinue use and consult a healthcare professional if a rash occurs. It is also important to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

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 one of the medications should be considered to alleviate symptoms. Monitoring for signs of skin irritation is recommended when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Glytone Acne Clearing Toner (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 GLYTONE Acne Clearing Toner 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 prescribing 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 no specific information available regarding the use of GLYTONE Acne Clearing Toner during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential. Given the lack of data on potential fetal impacts, it is advisable to consider alternative treatments that have established safety profiles during pregnancy. Further research may be necessary to clarify the implications of using this product in pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 is no information available 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.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance has been ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

It is imperative that healthcare providers remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary.

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 potential effects in nonclinical settings.

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 seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if a rash develops during treatment. It is important to note that skin irritation and dryness may be exacerbated if the patient is using another topical acne medication concurrently. Therefore, patients should be counseled to use only one topical acne medication at a time to minimize the risk of irritation.

Additionally, healthcare providers should instruct patients to avoid contact with the eyes. If the medication comes into contact with the eyes, patients should rinse thoroughly with water to mitigate any potential irritation.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety and integrity. Once opened, the product must be discarded to prevent any potential contamination or degradation.

Additional Clinical Information

The product is administered topically. After cleansing, patients should apply toner to a cotton pad and gently apply it over the affected area one to three times daily, without rinsing. To minimize the risk of excessive skin drying, it is recommended to start with one application daily, gradually increasing to two or three times daily as needed or directed by a clinician. If patients experience bothersome dryness or peeling, they should reduce the application frequency to once a day or every other day.

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

Drug Information (PDF)

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

View product document (PDF)