FDA.reportPublic FDA data

FDA label b5f75483-d4f1-6915-e053-2995a90ae0de

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
b5f75483-d4f0-6915-e053-2995a90ae0de
SPL ID
b5f75483-d4f1-6915-e053-2995a90ae0de
Version
1
Effective date
2020-12-08
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:30:43

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 and cautions

Warnings: For external use only. Not to be used on children. Do not apply to the eyelids, the edges of the nose and mouth, or to irritated or damaged slin. Avoid the eye area. For use during pregnancy, consult your doctor. Avoid sun exposure when using this product. In the first applications, you may experience a transient burning sensation or itchy or dry skin. If the discomfort persists, discontinue use of the product and consult your doctor. Keep out of the reach of children. Do not ingest In case of accidental contact with the eyes, rinse thoroughly with water. If irritation develops, discontinue use and consult your doctor.

Reported adverse events (FAERS/openFDA)#

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