FDA label 60c9d8b7-e09c-5532-e053-2a91aa0a2adb

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
81d65f3b-6dd4-4114-a638-de8b313c5d36
SPL ID
60c9d8b7-e09c-5532-e053-2a91aa0a2adb
Version
8
Effective date
2018-01-04
Source export date
2026-08-01
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/d245bd7ce31d1d8ed63276109973402ece6c44860774da30f25b731cd7418983/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:35:46

Warnings cross-check#

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

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Do not exceed the recommended daily dosage unless directed by a doctor put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if an allergic reaction develops condition worsens or does not improve witin 7 days redness, irriation, swelling, pain or other symptoms begin or increase bleeding occurs Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.

warnings and cautions

Warnings For external use only Do not exceed the recommended daily dosage unless directed by a doctor put this product into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if an allergic reaction develops condition worsens or does not improve witin 7 days redness, irriation, swelling, pain or other symptoms begin or increase bleeding occurs Keep out of reach of children. If swallowed, seek medical attention or contact a Poison Control Center right away.