Temcongyi

Uses and Indications

This drug is indicated for the removal of common warts, which are characterized by their rough, 'cauliflower-like' surface appearance. Additionally, it is indicated for the removal of corns and calluses.

Limitations of Use: This drug is not intended for use on moles, birthmarks, or warts with hair growing from them. It should not be applied to irritated skin or any area that is infected or inflamed.

Dosage and Administration

The affected area should be washed thoroughly prior to treatment. For optimal results, the wart may be soaked in warm water for approximately 5 minutes. After soaking, the area must be dried completely.

Using the provided applicator, the liquid should be applied one drop at a time to ensure sufficient coverage of each wart, corn, or callus. It is important to allow the application to dry completely.

This procedure may be repeated once or twice daily as necessary, continuing until the wart, corn, or callus is removed, with a maximum treatment duration of up to 12 weeks.

Contraindications

Use of this product is contraindicated in the following situations:

Application is not recommended on irritated skin or any area that is infected or reddened, as this may exacerbate the condition. Additionally, individuals with known allergies to any of the product's ingredients should refrain from use to avoid allergic reactions. The product should not be applied to moles, birthmarks, warts with hair growing from them, genital warts, or warts located on the face or mucous membranes, due to the potential for adverse effects in these areas.

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.

General precautions should be observed to ensure safe use. Users must avoid contact with the eyes; in the event of contact, it is imperative to flush the eye with water for at least 15 minutes. Inhalation of vapors should also be avoided to minimize respiratory irritation. Additionally, the bottle should be capped tightly when not in use to prevent leakage and maintain product integrity.

In case of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

If discomfort persists after use, it is advised to discontinue use of the product and consult a healthcare professional for further evaluation and guidance.

Side Effects

Patients should be aware of several important warnings and precautions associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from fire or flame.

The product should not be used on irritated skin or on any area that is infected or reddened. Additionally, individuals who are allergic to any of the ingredients in this product should refrain from use. It is contraindicated for application on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

During the use of this product, patients should avoid contact with the eyes. In the event that the product comes into contact with the eyes, it is recommended to flush the eyes with water for 15 minutes. Patients should also avoid inhaling vapors and ensure that the bottle is capped tightly when not in use.

Patients are advised to stop using the product and consult a doctor if discomfort persists.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Temcongyi (salicylic acid liquid). 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 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional 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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on irritated skin or any area that appears infected or reddened. Patients should be cautioned against using the product if they have a known allergy to any of its ingredients.

Additionally, healthcare providers should inform patients that the product should not be used on moles, birthmarks, warts with hair growing from them, genital warts, or warts located on the face or mucous membranes. Patients should be advised to discontinue use and consult a doctor if discomfort persists.

While using the product, patients must be reminded to avoid contact with their eyes. In the event that the product comes into contact with the eyes, they should flush the eyes with water for 15 minutes. Furthermore, patients should be instructed to avoid inhaling vapors from the product. Finally, it is essential to remind patients to cap the bottle tightly when it is not in use to maintain its integrity.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25℃ (68-77℉). Care should be taken to protect the product from excessive heat, specifically temperatures exceeding 40℃ (104℉). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)