Podocon 25
Podophyllum resin · Tincture · Topical
Uses
INDICATIONS: Podocon-25 ® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata) (4) .
Dosage and administration
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
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
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.
Precautions
PRECAUTIONS: Do not use Podocon-25 ® if wart or surrounding tissue is inflamed or irritated. Do not use on bleeding warts, moles, birthmarks or unusual warts with hair growing from them.
Side effects
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.
Pregnancy
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.
Description
DESCRIPTION: Podocon-25 ® is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake ( Podophyllum peltatum Linne’ ), a perennial plant of northern and middle United States (1) . The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has a reduced level of podophyllotoxin (see below).
How supplied
HOW SUPPLIED: Podocon-25 ® is available in 15-mL bottles with tapered tip applicator attached inside cap. NDC 0574- 0601 -15 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Rx Only 1) Blumgarten, A.F.: Text Book of Materia Medica, Pharmacology and Therapeutics; Ed. 7, New York, The Macmillan Company, 1937, pp. 220 and 223. 2) Green, L.K., Klima, M., Burns, T.; Arch Dermatol. Vol 124, Nov 1988, p. 1718. 3) Martindale, 28th Ed. London, 1982, pp. 1366, 1367. 4) Medical Letter; Vol 26, New Rochelle, N.Y., 1984, p 10. 5) Fisher: Severe Systemic and Local Reactions to Topical Podophyllum Resins; Cutis, Volume 28, 1981. 6) Zackheim: Hazards of Topical Mitotic-Blocking Agents; Arch. Dermat. Volume 113, 1977. Manufactured By Padagis Minneapolis, MN 55427 www.padagis.com 2204600 1J100 RC J1 Rev 06-22
Label text from the FDA structured product label by Padagis US LLC (revised Jun 30, 2022). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Podophyllum Resin in 4 products
Podocon 25 NDC products (4)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 63629-8699 | Podophyllum Resin 1 mg/4mL Tincture | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 71335-2925 | Podophyllum Resin 1 mg/4mL Tincture | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 72162-1117 | Podophyllum Resin 1 mg/4mL Tincture | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 0574-0601 | Podophyllum Resin 1 mg/4mL Tincture | Padagis US LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
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) .
What are the side effects of Podocon 25?
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… See the full label for the complete list.
Who makes Podocon 25?
Podocon 25 is listed by 2 labelers in the FDA NDC directory, including Bryant Ranch Prepack, Padagis US LLC.