FDA label f1eb10de-7b12-cac4-e053-2995a90a6d8e

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
cdc87b48-ec7c-958b-e053-2a95a90a8c9b
SPL ID
f1eb10de-7b12-cac4-e053-2995a90a6d8e
Version
2
Effective date
2023-01-10
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:09:17

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. When using this product Do not exceed the recommendeed daily dosage unless directed by a doctor. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if Bleeding occurs Condition worsens or does not improve within 7 days Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

Reported adverse events (FAERS/openFDA)#

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