FDA label 3fd4a3fb-6ae3-4029-83d7-cd5192668be4

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: 6d2428fc-4680-4dbd-9419-0374ea5a5060
SPL ID: 3fd4a3fb-6ae3-4029-83d7-cd5192668be4
Version: 1
Effective date: 2014-04-24
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:47:48

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		3fd4a3fb-6ae3-4029-83d7-cd5192668be4	id
spl set id		6d2428fc-4680-4dbd-9419-0374ea5a5060	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) Do not use this product if Pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, contact a doctor or Poison Control Center immediately. Tamper Evident "Warranty Void...Seal..label atop the container is broken. When using this product Do not exceed the recommended daily dosage unless directed by a doctor. Certain persons can develop allergic reactions to ingredients in this product. Do not put this product into the rectum by using fingers or any mechanical device or applicator. The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase. Keep out of reach of children. In case of accidental ingestion, seek medical attention immediately.

Reported adverse events (FAERS/openFDA)#

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