FDA label e2a46554-a189-4a81-b2ad-2297ba11adc0

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
c951336f-9cb2-40cc-98f3-b5c4d9f5e27d
SPL ID
e2a46554-a189-4a81-b2ad-2297ba11adc0
Version
12
Effective date
2024-04-01
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:39:13

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. Flammable, keep away from fire or flame. To reduce the risk of fire, PREP CAREFULLY: do not use 26-mL applicator for head and neck surgery do not use on an area smaller than 8 in. x 10 in. Use a small applicator instead. solution contains alcohol and gives off flammable vapors do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair). avoid getting solution into hairy areas. Wet hair is flammable . Hair may take up to 1 hour to dry. do not allow solution to pool remove solution-stained material from prep area Do not use on patients with known allergies to iodine or any other ingredients in this product on open wounds, on mucous membranes, or as a general skin cleanser in infants less than 2 months old due to the risk of excessive skin irritation and transient hypothyroidism When using this product keep out of eyes, ears, and mouth. May cause serious injury if permitted to enter and remain. If contact occurs, flush with cold water right away and contact a doctor. to avoid skin injury, care should be taken when removing drapes, tapes, etc…applied over film use with caution in women who are breast-feeding due to the potential for transient hypothyroidism in the nursing newborn Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition. On rare occasions, use of this product has been associated with skin blistering. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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