Podocon 25
Podophyllum Resin
Bryant Ranch Prepack
Human Prescription Drug
NDC 63629-8699Podocon 25 also known as Podophyllum Resin is a human prescription drug labeled by 'Bryant Ranch Prepack'. National Drug Code (NDC) number for Podocon 25 is 63629-8699. This drug is available in dosage form of Tincture. The names of the active, medicinal ingredients in Podocon 25 drug includes Podophyllum Resin - 1 mg/4mL . The currest status of Podocon 25 drug is Active.
Drug Information:
| Drug NDC: | 63629-8699 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Podocon 25 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Podophyllum Resin |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Bryant Ranch Prepack |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tincture |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PODOPHYLLUM RESIN - 1 mg/4mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Sep, 1990 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 27 Dec, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Bryant Ranch Prepack
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | 16902YVY2B
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 63629-8699-1 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (63629-8699-1) / 15 mL in 1 BOTTLE, WITH APPLICATOR | 01 Sep, 1990 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Podocon 25 podophyllum resin podophyllum resin podophyllum resin styrax benzoin resin alcohol
Indications and Usage:
Indications: podocon-25® (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata) (4) .
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.
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 patientâs 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).
Adverse Reactions:
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.
Use in 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 ( podophyllumpeltatumlinneâ ), 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).
Clinical Pharmacology:
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.
How Supplied:
How supplied podocon-25 ® is available in 15-ml bottles with tapered tip applicator attached inside cap. ndc 63629-8699-1 store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature] in tight, light-resistant containers. rx only
Package Label Principal Display Panel:
Podophyllum resin 25% tincture, #15 label