International reference: 1 US FDA recall for this ingredient

Lack of Assurance of Sterility (podophyllum)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Rwanda.

Registered Rwanda · Rwanda FDA

PODOSAL OINTMENT

Podophyllum resin 20% w/w, Salicylic acid 25% w/w

Rwanda FDA-HMP-MA-0469 Ointment 20% w/w, 25% w/w

What it does

Podophyllum is a natural substance used to treat certain skin conditions.

Commonly used for: warts, condylomata acuminata (genital warts)

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HMP-MA-0469
Registration date
24/08/2023
Expiry date
23/08/2028
Status
Registered
Active ingredient
Podophyllum resin 20% w/w, Salicylic acid 25% w/w
Dosage form
Ointment
Strength
20% w/w, 25% w/w
Pack size
10g Tube
Therapeutic class
-
Manufacturer / MAH
Biodeal Laboratories
Country of origin
KENYA
Manufacturer location
123 Lunga Lunga Rd, Nairobi, Kenya

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:32 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About podophyllum

Podophyllum is a natural substance used to treat certain skin conditions.

What it treats

  • warts
  • condylomata acuminata (genital warts)

How it works

Podophyllum works by causing the skin cells to die, which helps to remove warts and other growths.

Who it's for

Podophyllum is for adults and children who have specific types of warts or skin growths.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About resin

Resin is a natural substance used for various health purposes, often found in supplements.

What it treats

  • Digestive issues
  • Skin conditions
  • Respiratory issues

How it works

Resin may help improve health by supporting bodily functions and reducing inflammation.

Who it's for

Adults and children needing support for digestive or skin health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About salicylic

Salicylic acid is a medication commonly used to treat skin conditions such as acne and warts. It helps to exfoliate the skin and reduce inflammation.

What it treats

  • acne
  • warts
  • dandruff
  • psoriasis
  • seborrheic dermatitis

How it works

Salicylic acid works by helping the skin shed its outer layer, which can clear clogged pores and reduce the growth of skin cells that cause warts and other skin issues.

Who it's for

Salicylic acid is suitable for people with certain skin conditions like acne and warts, but it's important to use it as directed.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: podophyllum

Podophyllum, derived from the root of the American mandrake plant (Podophyllum peltatum), is a natural compound primarily utilized for its cytotoxic properties. It is most commonly used as a topical treatment for warts and certain types of cancer. The active components, podophyllotoxin and its derivatives, exhibit significant antitumor and antiviral activity, making them effective in treating various skin lesions.

Indications

  • Condylomata acuminata (genital warts)
  • Bowenoid papulosis
  • Certain types of skin cancers
  • Actinic keratosis

Dosage

Children: Refer to the BNF for Children for appropriate dosing information based on specific conditions and formulations.

Adults: Refer to the BNF for appropriate dosing information based on specific conditions and formulations.

Mechanism of action

Podophyllum exerts its therapeutic effects by inhibiting the enzyme topoisomerase II, which is essential for DNA replication and cell division. This inhibition leads to the disruption of the mitotic process in rapidly dividing cells, ultimately resulting in cell death. The compound's action is particularly effective against neoplastic cells and viral-infected cells, contributing to its use in oncology and dermatology.

Pharmacodynamics

The pharmacodynamics of podophyllum are characterized by its antimitotic and cytotoxic effects. By interfering with the normal cell cycle, particularly during the S and G2 phases, podophyllum induces apoptosis in affected cells. The extent of its effect is dose-dependent, with higher concentrations leading to increased cell death. Additionally, podophyllum has shown activity against certain viruses, including human papillomavirus (HPV), which is responsible for genital warts and other lesions.

Pharmacokinetics

Podophyllum is usually administered topically, which limits systemic absorption. When applied to the skin, the bioavailability is low, and systemic effects are minimal. However, when ingested or improperly used, it can lead to significant toxicity. The compound is metabolized in the liver, and its metabolites are excreted primarily via the kidneys. The half-life of podophyllum can vary based on the route of administration and the individual's metabolic rate.

Contra-indications

  • Pregnancy
  • Lactation
  • Severe liver dysfunction
  • Hypersensitivity to podophyllum or any of its components

Adverse effects

  • Nausea
  • Vomiting
  • Abdominal pain
  • Diarrhea
  • Headache
  • Dizziness
  • Skin irritation
  • Local necrosis at the application site

Interactions

  • May interact with other cytotoxic agents
  • Caution advised when used with anticoagulants due to potential for increased bleeding

Precautions

  • Use with caution in patients with liver impairment
  • Monitor for signs of toxicity, especially in patients receiving other medications that affect liver function
  • Not to be used in large areas of skin or on open wounds

Pregnancy

Podophyllum is contraindicated during pregnancy due to its potential teratogenic effects.

Breast-feeding

The use of podophyllum during breastfeeding is not recommended due to the risk of serious adverse effects in the infant.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Topical solution
  • Gel
  • Ointment

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: resin

BNF-referenced

Resin is a complex mixture of organic compounds that can be derived from various plants, particularly conifers. It is primarily composed of terpenoids and is used in various medicinal and industrial applications. In the context of pharmacy, resins are often utilized for their therapeutic properties, including their potential anti-inflammatory and analgesic effects. They can also serve as excipients in pharmaceutical formulations, aiding in drug delivery and stability.

Indications

  • Inflammatory conditions
  • Pain management
  • Topical antiseptic
  • Excipient in pharmaceutical formulations

Dosage

Children: Refer to specific formulation and clinical guidelines for dosage.

Adults: Refer to specific formulation and clinical guidelines for dosage.

Mechanism of action

Resins exert their action through several mechanisms depending on the specific type. Many resins contain compounds that modulate inflammatory pathways, inhibit microbial growth, and exhibit antioxidant properties. For example, terpenoids in resin may interact with cellular receptors and enzymes that are involved in the inflammatory response, leading to reduced inflammation and pain.

Pharmacodynamics

Pharmacodynamics of resin varies based on its composition. Generally, the active components in resin can influence various biological pathways, including modulation of neurotransmitter release, alteration of cytokine production, and interference with cell signaling pathways associated with inflammation and infection. The effects can be dose-dependent and influenced by the route of administration.

Pharmacokinetics

The pharmacokinetics of resin is not well characterized due to its complex composition and variability among different types of resin. However, in general, the absorption of resin components can occur through oral, topical, or inhalation routes. Metabolism may occur in the liver, where certain terpenoids are converted into more water-soluble metabolites. Elimination typically occurs through urine and feces, although specific half-lives can vary widely.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: salicylic

BNF-referenced

Salicylic acid is a beta hydroxy acid that is commonly used for its keratolytic and anti-inflammatory properties. It is primarily used in the treatment of skin conditions such as acne, psoriasis, and warts. Salicylic acid works by promoting the shedding of the outer layer of skin and reducing inflammation, making it effective in managing various dermatological issues. It also has a role in managing conditions related to joint pain and inflammation.

Indications

  • Acne vulgaris
  • Psoriasis
  • Warts
  • Seborrheic dermatitis
  • Dandruff
  • Hyperkeratosis

Dosage

Adults: For topical application, salicylic acid is typically applied once or twice daily, depending on the formulation and condition being treated. Specific dosing guidelines should be followed as per the BNF.

Mechanism of action

Salicylic acid exerts its effects by penetrating the skin and exfoliating the stratum corneum through keratolytic action, which helps in the dissolution of keratin and the removal of dead skin cells. This action facilitates the clearance of pores and can reduce acne lesions. Additionally, salicylic acid has anti-inflammatory properties that can help to decrease swelling and redness associated with various skin conditions. The compound is also known to inhibit the activity of enzymes involved in the synthesis of prostaglandins, which are mediators of inflammation.

Pharmacodynamics

The pharmacodynamics of salicylic acid involve its ability to enhance the turnover of skin cells and reduce the cohesiveness of keratinocytes in the stratum corneum. This leads to increased desquamation and a reduction in the formation of microcomedones in acne. Its anti-inflammatory effects are mediated through the inhibition of cyclooxygenase enzymes, leading to decreased production of pro-inflammatory mediators. This contributes to the reduction of inflammation and pain in affected areas.

Pharmacokinetics

Salicylic acid is absorbed percutaneously when applied topically, with systemic absorption increasing with higher concentrations and prolonged application. Once absorbed, it is metabolized predominantly in the liver to various conjugates, which are then excreted by the kidneys. The elimination half-life can vary based on the formulation and concentration used. For topical applications, significant first-pass metabolism may occur, limiting systemic exposure and reducing potential systemic side effects.

Pregnancy

Salicylic acid is classified as pregnancy category C. Its use should be avoided during pregnancy unless the potential benefits outweigh the risks.

Breast-feeding

Salicylic acid is excreted in breast milk, and caution is advised when using it during breastfeeding.

Storage

Store in a cool, dry place away from direct light.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: resin

PubChem CID 133110026

Molecular formula: C15H24

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: salicylic

PubChem CID 73952057

Molecular formula: C14H12MgO6+2

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.