FDA.reportPublic FDA data

FDA label e4625695-492b-db10-e053-2a95a90a4c83

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
d045a680-b885-a288-e053-2a95a90a3e70
SPL ID
e4625695-492b-db10-e053-2a95a90a4c83
Version
2
Effective date
2022-07-22
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 06:30:19

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings For External Use Only Do not use other creams or cosmetics with the monodose. Do not get the area wet once the patch is in place. Avoid Contact with Eyes Stop Use and Ask Doctor If Condition Worsens Symptoms last more than 7 days Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

warnings and cautions

For External Use Only Do not use other creams or cosmetics with the monodose. Do not get the area wet once the patch is in place.

warnings and cautions

Avoid Contact with Eyes

Reported adverse events (FAERS/openFDA)#

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