FDA label c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f

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: 3d69bc86-aa79-4f06-ab39-59aa41f82b54
SPL ID: c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f
Version: 6
Effective date: 2024-01-25
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 02:41:08

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		c9cb8c59-1b93-4fa8-88dc-c2dc434b2f8f	id
spl set id		3d69bc86-aa79-4f06-ab39-59aa41f82b54	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 For use in adults and children over 12 years. When using this product • Use only as directed. • Do not use with a heating pad. • Avoid contact with eyes and mucous membranes. • Do not apply to wounds or damaged, broken or irritated skin. Stop use and ask a doctor if • Condition worsens. • Irritation or redness develops. • Symptoms persist for more than 7 days or clear up and occur again within a few days. If pregnant or breast-feeding, ask a doctor before use. Keep out of reach of children. If swallowed by accident, get medical help.

Reported adverse events (FAERS/openFDA)#

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