FDA label 197548f3-a02e-4b8b-b11f-66c91baf6709

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
2f025229-9947-4b1a-bf26-614043cc3fa6
SPL ID
197548f3-a02e-4b8b-b11f-66c91baf6709
Version
6
Effective date
2012-01-11
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 02:34:07

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

For external use only. • Avoid contact with eyes, lips, nose or any mucous membrane. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Do not use on wounds or damaged or irritated skin. Discontinue use if irritation develops. Do not use on children under 2 years of age unless directed by a doctor. When using this product do not bandage tightly or use any heat source (pads, compresses, warm water, etc.) with applications of Theragen. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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