Label: PODOCON 25- podophyllum resin tincture
- NDC Code(s): 63629-8699-1
- Packager: Bryant Ranch Prepack
- This is a repackaged label.
- Source NDC Code(s): 0574-0601
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated July 17, 2023
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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 (PodophyllumpeltatumLinne’ ), 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).
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CLINICAL PHARMACOLOGY:
Podophyllin is a cytotoxic agent that has been used topically in the treatment of genital warts. It arrests mitosis in metaphase, an effect it shares with other cytotoxic agents such as the vinca alkaloids(2). The active agent is podophyllotoxin, whose concentration varies with the type of podophyllin used; the American source normally containing one-fourth the amount of podophyllotoxin as the Indian source(3).
NOTE: PODOCON-25® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT.
- INDICATIONS:
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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:
- PRECAUTIONS:
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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.
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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.
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PODOCON 25
podophyllum resin tinctureProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-8699(NDC:0574-0601) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PODOPHYLLUM RESIN (UNII: 16902YVY2B) (PODOPHYLLUM RESIN - UNII:16902YVY2B) PODOPHYLLUM RESIN 1 mg in 4 mL Inactive Ingredients Ingredient Name Strength STYRAX BENZOIN RESIN (UNII: FE663Z8IRO) ALCOHOL (UNII: 3K9958V90M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63629-8699-1 1 in 1 CARTON 09/01/1990 1 15 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 09/01/1990 Labeler - Bryant Ranch Prepack (171714327) Registrant - Bryant Ranch Prepack (171714327) Establishment Name Address ID/FEI Business Operations Bryant Ranch Prepack 171714327 REPACK(63629-8699) , RELABEL(63629-8699)
