FDA.reportPublic FDA data

FDA label b34c9b12-012e-e6f0-e053-2a95a90a0ae2

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
dc915d8e-432e-42a9-8175-821faf795ac2
SPL ID
b34c9b12-012e-e6f0-e053-2a95a90a0ae2
Version
2
Effective date
2020-11-04
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:21:38

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

Warnings: For External Use Only. Do not use on inflamed or brocken skin to prevent sunburn if product is tan or brown When using this product mild irration may occur avoid contact with eyes. If contact occurs, Rinse With water. avoid unnecessary sun exposure and use a sunscreen or protective clothing Stop use and ask a doctor if a gradual blue black darkening of the skin occurs irritation is severe no improvement is seen after 3 months If pregnant or breast-feeding consult a health professional before use Keep out of reach of children

Reported adverse events (FAERS/openFDA)#

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