FDA label e3a78612-ec3a-6b8d-e053-2995a90ae708

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
1cd82c67-e0ca-416c-9765-34d81b97c575
SPL ID
e3a78612-ec3a-6b8d-e053-2995a90ae708
Version
20
Effective date
2022-07-12
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:32

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

For external use only. When using this product 1. The product should not be used on: 1) Mucous membrane, including the eyes; 2) People who are allergic to the listed ingredients; 3) People with eczema acutum or inflammatory skin diseases; 4) People who suffer from chronic renal insufficiency. 2. Ask a doctor before use: 1) If you are suffering from inflammatory skin diseases and skin fissures (using this product may induce temporary reaction); 2) If you have hypersensitive skin (using this product may induce temporary reaction). 3. Side effects: 1) You may experience skin irritation, burning, redness, dryness, pain, and rash when you use the product for the first time. Seek medical help if you have any doubts; 2) You may experience hypersensitivity. Stop using the product immediately. If symptoms persist, consult your doctor; 3) You may experience skin eczematization, skin fissures, papule, stinging, burning and, rarely, edema and dryness. Stop using the product immediately. If symptoms persist, consult your doctor. 4. Using this product may increase dermal absorption and penetration of the following ingredients: corticoid, dithranol, fluorouracil (5-FU) and alike. 5. Precautions in application: 1) For external use only; 2) Do not directly apply on ulcers, macerations, cuts or infected areas; 3) Be careful not to get product into your eyes. If any product gets into your eyes, flush immediately with a large amount of lukewarm water for at least 15 minutes and seek medical attention (Do not rub your eyes or arbitrarily apply medications). 6. Precaution in storage: Store at room temperature, away from direct sunlight. Keep this out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Always recap after use. Keep this and all drugs out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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