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Topical green tea catechin extract Pregnancy: UK SPC section 4.6: there are no or limited data from use in pregnant women and studies in animals have shown reproductive toxicity; as a precautionary measure it is preferable to avoid the use of Catephen during pregnancy, although systemic exposure to epigallocatechin gallate is expected to be low following dermal application. Breast-feeding: it is unknown whether Catephen or its metabolites are excreted in human milk and a risk to the suckling child cannot be excluded, though no effects on the breastfed newborn/infant are anticipated since systemic exposure is expected to be low. Fertility: no evidence of an effect on fertility in the rat following dermal (male) and vaginal (female) application.

Camellia sinensis (sinecatechins)

Brand names: Catephen

Camellia sinensis extract (sinecatechins), derived from green tea leaves, is a topical ointment used for the treatment of external anogenital warts.

Adult dose

Dose: External genital and perianal warts: up to 250 mg ointment as a total single dose (about 0.5 cm of ointment strand), applied to all warts
Route: Topical — cutaneous use only. Dab a small amount on to each wart with the fingers to ensure complete coverage, leaving a thin layer on the warts. Only apply to affected areas; any application into the vagina, urethra or anus must be avoided. Do not apply to mucous membranes.
Frequency: Three times per day
Max: 250 mg in total for all warts per single dose; 750 mg total daily dose; maximum treatment duration 16 weeks in total
VERBATIM UK SPC section 4.2: "Up to 250 mg Catephen ointment as total single dose, corresponding to about 0.5 cm of ointment strand to be applied three times per day to all external genital and perianal warts (750 mg total daily dose)." DURATION: "Treatment with Catephen should be continued until complete clearance of all warts, however, no longer than 16 weeks in total (max. duration), even if new warts develop during the treatment period." METHOD: "A small amount of Catephen should be applied to each wart using the fingers, dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts (max. 250 mg in total for all warts/ per single dose)." "If a dose is missed, the patient should continue with the normal treatment regimen. It is recommended to wash the hands before and after application of Catephen. It is not necessary to wash off the ointment from the treated area prior to the next application. Catephen should be washed off the treated area before sexual activity. Female patients using tampons should insert the tampon before applying Catephen." HEPATIC IMPAIRMENT: "Patients with severe liver dysfunction (e.g. clinically relevant elevation of liver enzymes, increase of bilirubin, increase of INR) should not use Catephen due to insufficient safety data." OLDER PEOPLE: "An insufficient number of older people were treated with Catephen ointment to determine whether they respond differently from younger subjects." Some sections of the product information we used were incomplete — check the full SPC. NOT USED: the bundle's openFDA record is "AOAO Repair Foot Cream" (Guangdong Junhui Biotechnology, 2025-01-08), a cosmetic-type foot cream whose entire posology text is "D0SAGE Approximately 0.1-0.2 oz each time" — an unrelated product, deliberately excluded.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (section 4.3)
  • Section 4.4: must not be used for the treatment of urethral, intra-vaginal, cervical, rectal or intra-anal warts — Catephen has not been evaluated for these
  • Section 4.4: patients with severe liver dysfunction (e.g. clinically relevant elevation of liver enzymes, increase of bilirubin, increase of INR) should not use Catephen due to insufficient safety data
  • Section 4.4: patients taking immunomodulatory medicines should not use Catephen — effectiveness and safety in these patients have not been investigated
  • Section 4.4: should not be applied to open wounds, broken or inflamed skin; therapy is not recommended until the skin has completely healed from any previous surgical or drug treatment
  • Section 4.2: safety and efficacy in children and adolescents below the age of 18 years have not been investigated — no data are available

Side effects

  • Very common: local reactions at the application site — erythema, pruritus, irritation/burning, pain, ulcer, oedema, induration and vesicles (83.5% of patients in pivotal studies experienced local skin/application site reactions)
  • Common: local reactions at the application site — exfoliation, discharge, bleeding and swelling
  • Common: inguinal lymphadenitis/lymphadenopathy
  • Common: phimosis (occurred in 1.9% of uncircumcised male subjects)
  • Uncommon: local reactions at the application site — discolouration, discomfort, dryness, erosion, fissure, hyperaesthesia, anaesthesia, scar, nodule, dermatitis, hypersensitivity, local necrosis, papules and eczema
  • Uncommon: application site infection, application site pustules, genital herpes infection, staphylococcal infection, urethritis, vaginal candidiasis, vulvovaginitis
  • Uncommon: dysuria, micturition urgency, pollakisuria
  • Uncommon: balanitis, dyspareunia
  • Severe local reactions were reported in 26.8% of patients at least once during treatment (male 20.8% / female 33.5%); female patients with warts in the vulva had a higher incidence of local skin and application site reactions
  • Hypersensitivity was observed in 5/209 subjects (2.4%) in a dermal sensitisation study — treatment should be discontinued in case of hypersensitivity
  • This side-effect list may be incomplete — check the full SPC.

Monitoring

  • Mild local skin reactions are related to the mode of action and should not lead to discontinuation; they should decrease after the first weeks of treatment (section 4.4)
  • Interrupt treatment if a more intense local skin reaction causes unacceptable discomfort, increases in severity, or is associated with a lymph node reaction; resume once the reaction has diminished (section 4.4)
  • If a vesicular local reaction occurs, advise the patient to consult a doctor to exclude a genital herpes infection (section 4.4)
  • Uncircumcised male patients treating warts under the foreskin should retract the foreskin and clean the area daily to prevent phimosis; stop treatment at early signs of stricture (ulceration, induration or increasing difficulty in retracting the foreskin) (section 4.4)
  • Avoid contact with the eyes, nostrils, lips and mouth; in case of accidental application into the vagina, immediately wash off with warm water and mild soap (section 4.4)
  • Catephen may weaken condoms and vaginal diaphragms — wash the ointment off before use of condoms and sexual contact, and consider additional methods of contraception; use condoms until complete clearance as Catephen does not eliminate HPV or prevent transmission (section 4.4)
  • Do not expose the treated area to sunlight or UV irradiation; avoid occlusive dressings (section 4.4)
  • Safety and effectiveness beyond 16 weeks, or for multiple treatment courses, have not been investigated (section 4.4)

Clinical monograph

How it works

The catechins, predominantly epigallocatechin gallate, have antioxidant and immunomodulatory properties, although the precise mechanism in clearing genital warts is not fully established.

Prescribing in practice

  • Local skin and mucosal reactions such as erythema, itching, burning and pain are very common and expected as part of treatment.
  • It should not be applied to open wounds, and the treated area should not be covered with occlusive dressings.
  • It may weaken latex condoms and diaphragms, so advise on alternative contraception during use.

Monitoring

Review the treated area periodically for response and to assess the severity of local reactions.

Counselling the patient

  • Apply a thin layer to each wart and do not wash off before the next planned application.
  • Local redness, itching and discomfort are common and usually tolerable.
  • Avoid relying on condoms or diaphragms for protection while using this ointment.

Evidence & guidelines

Sinecatechins ointment is licensed for the treatment of external anogenital warts based on its clinical trial evidence.

Reference: BASHH HPV/warts guideline; SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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