FDA.reportPublic FDA data

FDA label c7c72ba6-85e0-9098-e053-2a95a90a23a9

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
96af378e-a928-5daf-e053-2995a90abd4e
SPL ID
c7c72ba6-85e0-9098-e053-2a95a90a23a9
Version
4
Effective date
2021-07-23
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:07:59

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 KEEP OUT REACH OF CHILDREN If swallowed, get medical help or contact a Poison Control Center right away. STOP USE AND ASK DOCTOR IF Condition worsens Symptoms last more than 7 days

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

Adverse reactions cross-check#

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

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

adverse reactions

To report suspected adverse reactions contact 1-800-332-1088

Reported adverse events (FAERS/openFDA)#

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