FDA label 361e0444-1d55-405b-a8de-5bdcdead49db

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
d33749f0-0205-4ad2-bc8a-83482e379ef7
SPL ID
361e0444-1d55-405b-a8de-5bdcdead49db
Version
2
Effective date
2012-01-13
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:26:14

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS There exists the potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to prove hypersensitivity may be inconclusive 1 . If an occlusive dressing is used, there may be an increase in the incidence of inflammatory reactions in the adjacent normal skin. The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with FLUOROPLEX ® Cream, as the intensity of the reaction may be increased.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported. Occasionally, hyperpigmentation and scarring have also been reported.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.