FDA label 57af7d5f-70ee-4945-a9ef-f57dba6bf6b0

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: de3580fb-e167-4ee7-adc5-fe43ac10ae1d
SPL ID: 57af7d5f-70ee-4945-a9ef-f57dba6bf6b0
Version: 2
Effective date: 2022-09-22
Source export date: 2026-10-12
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/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:38:06

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		57af7d5f-70ee-4945-a9ef-f57dba6bf6b0	id
spl set id		de3580fb-e167-4ee7-adc5-fe43ac10ae1d	set_id

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 Stop use and consult a doctor •in case of bleeding •if conditions worsenor deos not improve within 7 days <Do not exceed recommended daily dosage unless directed by a doctor Do not put prodcut into rectum by using fingers or any mechanical device or applicator Allergy Alert:Certain persons can develop allergic reactions to this product. If the symptoms develop or increase,discontinue use and consult a doctor. > Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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