FDA label b129a61d-c9f4-40af-ad62-4b909969ad45

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: b59ef732-6026-4948-9c25-0533dfa30911
SPL ID: b129a61d-c9f4-40af-ad62-4b909969ad45
Version: 4
Effective date: 2020-10-22
Source export date: 2026-10-12
Source partition: 2
Source file: https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:30:25

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		b129a61d-c9f4-40af-ad62-4b909969ad45	id
spl set id		b59ef732-6026-4948-9c25-0533dfa30911	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: Do not use if allergic to any ingredient in this product. inside the mouth or eyes. Ask a doctor or pharmacist before use if you are under 12 years of age. When using this product DO NOT SHARE APPLICATOR Handle glass applicator with Caution. Discard safely after use. FOR TOPICAL USE ONLY. DUE TO THE NATURE OF THE PRODUCT CONTAINING HERBAL EXTRACTS SOME SEDIMENTS MAY BE VISIBLE. THIS DOES NOT AFFECT THE EFFICACY OR USE OF THE PRODUCT. Stop use and ask a doctor if symptoms persist or worsen discontinue use and seek medical attention. If pregnant or breast-feeding, or have hypersensitive skin consult a healthcare practitioner prior to use. Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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