FDA label f5f214bf-91d5-4c95-90d0-d85fea6e759e

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
a1a966b0-7e40-4d83-bcf9-dac0f43112da
SPL ID
f5f214bf-91d5-4c95-90d0-d85fea6e759e
Version
3
Effective date
2024-12-23
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:44:12

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings – 10.5 mL Applicator For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet materials from prep area Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings – 26 mL Applicator For external use only. Flammable, keep away from fire or flame. To reduce risk of fire, PREP CAREFULLY: ▪ do not use 26-mL applicator for head and neck surgery ▪ do not use on an area smaller than 8.4 in x 8.4 in. Use a smaller applicator instead. ▪ solution contains alcohol and gives off flammable vapors ▪ avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry. ▪ 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) ▪ do not allow solution to pool ▪ remove wet materials from prep area Do not use ▪ on patients allergic to isopropyl alcohol or any other ingredient in this product ▪ for lumbar puncture or in contact with the meninges ▪ on open skin wounds or as a general skin cleanser When using this product keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor. Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition. 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.