Oxy

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the treatment of acne. It effectively clears acne pimples and facilitates skin healing. The formulation penetrates pores to control the formation of blackheads and whiteheads, while also helping to prevent the emergence of new acne pimples.

No teratogenic or nonteratogenic effects have been mentioned in the available data.

Dosage and Administration

Healthcare professionals should ensure that the skin is thoroughly cleansed prior to the application of the patch. The patch should be applied directly to the affected area(s).

Initial treatment should begin with one application daily. Based on the patient's response and as directed by a physician, the frequency of application may be gradually increased to two or three times daily.

In cases where bothersome dryness or peeling occurs, it is recommended to reduce the application frequency to once daily or every other day. To remove the patch, gently peel it back and discard it appropriately.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes, lips, or mouth should be avoided. In the event of contact, the affected area must be flushed thoroughly with water to prevent irritation.

Concurrent use with other topical acne medications is not recommended, as this may increase the likelihood of skin irritation and dryness. Only one topical acne medication should be used at a time to minimize these risks.

Consult a healthcare professional prior to use if pregnant or breastfeeding, as safety in these populations has not been established.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes, lips, and mouth. In the event of accidental contact, the affected area should be flushed thoroughly with water to mitigate any potential irritation.

The concurrent use of this product with other topical acne medications may increase the likelihood of skin irritation and dryness. To minimize the risk of adverse effects, it is recommended that only one topical acne medication be used at a time.

Healthcare professionals should advise patients who are pregnant or breastfeeding to consult with a qualified health professional prior to using this product to ensure safety for both the mother and child.

This product should be kept 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 should be aware that it is for external use only. Care should be taken to avoid contact with the eyes, lips, and mouth; in the event of contact, the affected area should be flushed thoroughly with water.

Skin irritation and dryness are common adverse reactions associated with the use of this product, particularly if another topical acne medication is used concurrently. To minimize the risk of irritation, it is advised that patients use only one topical acne medication at a time.

In pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use to ensure safety for both the patient and the child.

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

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 is recommended to alleviate symptoms. Monitoring for signs of skin irritation is essential when initiating or adjusting treatment regimens involving topical acne therapies.

Packaging & NDC

Below are the non-prescription pack sizes of Oxy (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.

For topical application, it is recommended to initiate treatment with one application daily to minimize the risk of excessive skin drying. Dosage may be gradually increased to two or three times daily as needed or directed by a healthcare professional. Should patients experience bothersome dryness or peeling, the frequency of application should be reduced to once daily or every other day.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. 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 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 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.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific nonclinical toxicology data. Additionally, no details are provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Patients should be advised to avoid contact with the eyes, lips, and mouth when using this medication. In the event of contact, they should flush the area thoroughly with water to minimize irritation.

It is important to inform patients that the likelihood of skin irritation and dryness may increase if they are using another topical acne medication concurrently. Therefore, they should be counseled to use only one topical acne medication at a time to reduce the risk of irritation.

Additionally, patients who are pregnant or breastfeeding should be encouraged to consult with a healthcare professional before using this medication to ensure safety for themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature not exceeding 25°C (77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The product is administered topically, with an initial recommendation of one application daily. Patients may gradually increase the frequency to two or three times daily as needed or as directed by a healthcare professional.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is also important to advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Drug Information (PDF)

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

View product document (PDF)