Podocon 25

Podocon 25 is an FDA-registered drug product whose active ingredient is PODOPHYLLUM RESIN. It is labelled by Bryant Ranch Prepack taken by topical and marketed as a human prescription drug product. Identifiers on file: NDC 63629-8699, label effective 20230717. It is one of 2 FDA drug label records sharing the active ingredient PODOPHYLLUM RESIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing PODOPHYLLUM RESIN are most often described in connection with: indications podocon-, podophyllin benzoin, tincture indicated, removal soft, genital venereal, warts condylomata. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS: Podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata) (4) .

DOSAGE AND ADMINISTRATION: PODOCON-25 ® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL. Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25® sparingly to lesion. Avoid contact with healthy tissue. Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is a powerful caustic and severe irritant, it is recommended the first application of Podocon-25® be left in contact for only a short time (30-40 minutes) to determine patient’s sensitivity. To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to 4 hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique. Large areas or numerous warts should not be treated at once. After treatment time has elapsed, remove dried Podocon-25® thoroughly with alcohol or soap and water.

CONTRAINDICATIONS: Podocon-25® is contraindicated in diabetics, patients using steroids or with poor blood circulation. Podocon-25® should not be used on bleeding warts, moles, birthmarks or unusual warts with hair growing from them. It is recommended that Podocon- 25® not be used during pregnancy (see Pregnancy warning below).

WARNINGS: Podophyllin is a powerful caustic and severe irritant. Keep away from the eyes; if eye contact occurs, flush with copious amounts of warm water and consult physician or poison control center immediately for advice.

ADVERSE REACTIONS: The use of topical podophyllin has been known to result in paresthesia, polyneuritis, paralytic ileus, pyrexia, leukopenia, thrombocytopenia, coma and death (5) . Pregnancy: There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth (6) . In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients. Nursing Mothers: It is not known whether podophyllin is excreted in human milk following topical application. In the absence of controlled safety studies, podophyllin remains contraindicated for use on nursing patients.

FDA lists 2 drug label records with PODOPHYLLUM RESIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Podocon 25 used for?
INDICATIONS: Podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata) (4) .

Who makes Podocon 25?
Bryant Ranch Prepack is the labeler of record for Podocon 25. 2 FDA label records share the active ingredient PODOPHYLLUM RESIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Podocon 25 come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Podocon 25 prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing PODOPHYLLUM RESIN?
Yes. 2 FDA drug label records list PODOPHYLLUM RESIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Podocon 25 been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.