FDA label 471f4e23-e22f-6d66-e063-6394a90ae124

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
781e4746-4215-851a-e053-2a91aa0a42ca
SPL ID
471f4e23-e22f-6d66-e063-6394a90ae124
Version
3
Effective date
2025-12-29
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:12:49

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 Use may result in increased topical anti-inflammatory effects of steroids, due to presence of marshmallow herb When using this product Avoid contact with eyes and mucous membranes; if this happens, rinse with vegetable oil 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 Do not use On wounds or damaged skin If allergic to marshmallow root or chickweed if pregnant or breast-feeding ask a health professional before use keep out of reach of children if product is swallowed, get medical help or contact a Poison Control Centre right away

Reported adverse events (FAERS/openFDA)#

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