Restoral

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)

Brand name
Restoral
Generic name
MENTHOL
Manufacturer
Saje Natural Business Inc.
Product type
HUMAN OTC DRUG
SPL set ID
5b6176c1-9ed9-1950-e053-2a91aa0a434e
SPL ID
485269a3-5a54-ae1e-e063-6294a90ae1de
Version
9
Effective date
2026-01-13
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:36
Harmonized routes table
Harmonized routes
TOPICAL

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 Drug facts box 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.