FDA label 31dd1fb8-e662-eae8-e063-6394a90ab5e8

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
31dd1fb8-e661-eae8-e063-6394a90ab5e8
SPL ID
31dd1fb8-e662-eae8-e063-6394a90ab5e8
Version
1
Effective date
2025-04-03
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:07:41

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. Do not use ● on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor ●if irritation occurs or if there is no improvement within 4 weeks. When using this product ●Possible side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur. Keep out of reach of children. If swallowed,get medical help or contacta Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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