FDA label 5419af8a-1318-4947-a69b-029b1e7c9345

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: 2d872636-2e19-4f8b-ad61-160b892b4079
SPL ID: 5419af8a-1318-4947-a69b-029b1e7c9345
Version: 2
Effective date: 2022-04-28
Source export date: 2026-10-12
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:19:59

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		5419af8a-1318-4947-a69b-029b1e7c9345	id
spl set id		2d872636-2e19-4f8b-ad61-160b892b4079	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. If pregnant, breast-feeding, taking birth control or on hormone replacement therapy, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. When using this product: Do not get into eyes. Stop use and ask a doctor if: Condition worsens Symptoms last more than 7 days. This product is not intended as an alternative hormone therapy.

Reported adverse events (FAERS/openFDA)#

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