Podofilox 5 mg/g Gel, 3.5 g
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Antivirals class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Podofilox is used to treat warts in the genital and anal area. Podofilox is in a class of medications called keratolytic agents. It works by slowly killing cells in the tissue that makes up the wart.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
-
UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII U3JF91U133
Hydroxypropyl cellulose is a plant-derived polymer that acts as a binder, thickener, and film-former in medications. It helps hold tablet ingredients together, control how quickly the drug dissolves, and create protective coatings on pills.
-
UNII 33X04XA5AT
Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
-
UNII TU7HW0W0QT
A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $127.020 | $444.57 / 3.5 g |
| Medicaid paysCMS SDUD · 12 mo | $125.89 | $440.63 / 3.5 g |
| Medicare drug plans payPart D · Q2 2026 | $123.28 | $431.46 / 3.5 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Podofilox 5 mg/gthis 00574-0621-05 | Padagis | 3.5 g | $127.020 | — | Availability likely | — |
| Condylox 5 mg/g 00023-6118-03 | Allergan, | 3.5 g | $172.001 | — | Availability likely | +35% |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00574-0621-05 You're viewing this | 3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05) | 2023-12-13 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Podofilox gel is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis.
Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated. Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one-week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles.
If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.
Podofilox gel should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm 2 or less of wart tissue and to no more than 0.5 gram of the gel per day.
Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.
⛔ Contraindications ▾
CONTRAINDICATIONS Podofilox gel is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.
⚠️ Warnings ▾
WARNINGS Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Podofilox gel is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice. Drug Product is Flammable. Keep Away from Open Flame.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS In clinical trials with podofilox gel, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment.
Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discoloration, tenderness, dryness, crusting, fissures, soreness, ulceration, swelling/edema, tingling, rash, and blisters. The most common systemic adverse event reported during the clinical studies was headache (7%).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2 , approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5 mg/kg (29.5 mg/m 2 , approximately 19 times the recommended maximum human dose.) 9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic.
There are no adequate and well-controlled studies in pregnant women. Podofilox gel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients have not been established.
🆘 Overdosage ▾
OVERDOSAGE Topically applied podofilox may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible.
10 Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures. 11 Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Mechanism of Action Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown. Pharmacokinetics In systemic absorption studies in 52 patients, topical application of 0.05 mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels.
Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments 1 .
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Podofilox Gel 0.5% is supplied as 3.5 grams of clear gel in aluminum tubes with an applicator tip. NDC 0574-0621-05. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Avoid excessive heat. Do not freeze. Keep out of reach of children. Rx only
📋 Description ▾
DESCRIPTION Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum ). Podofilox gel is formulated for topical administration. Each gram of gel contains 5 mg of podofilox in a buffered alcoholic gel containing alcohol (81% v/v), butylated hydroxytoluene, glycerin, hydroxypropyl cellulose, lactic acid, and sodium lactate.
Podofilox has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is [5R,-(5α, 5aβ, 8aα, 9α]-5,8,8a,9-tetrahydro-9-hydroxy- 5-(3,4,5-trimethoxyphenyl) furo[3',4':6,7]naphtho-[2,3,-d]-1,3-dioxol-6(5aH)-one. Podofilox has the following structural formula: podofilox-structure-07-19
💬 Information for Patients ▾
Information for Patients Patients using podofilox gel should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects.
1) This medication should be used only as directed by the health care provider. Patients should be instructed to wash their hands thoroughly before and after each application. It is for external use only.
Avoid contact with the eyes. 2) Patients should be advised not to use this medication for any disorder other than for which it was prescribed. 3) Patients should report any signs of adverse reactions to the health care provider.
4) If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.