FDA.reportPublic FDA data

FLE Disinfectant

Manufacturer
Moisture 22 Co., Ltd.
Effective date
2022-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:43:36

Label at a glance#

ProductFLE Disinfectant
Active ingredientTHYMOL
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Thymol 0.3%

OTC - PURPOSE SECTION

Antifungal

WARNINGS SECTION

For External use only.

Do not use if you are allergic to any of the ingredients.

INDICATIONS & USAGE SECTION

For sanitizing to decrease bacteria.

OTHER SAFETY INFORMATION

Properly store in cool, dry area: avoid direct sunlight. Store up to 5 years in a sealed container.

INACTIVE INGREDIENT SECTION

2-Phenoxyethanol, Water, Glycerol, 1,2-Propylene glycol, Triethylene glycol, 1.2-Hexanediol, Pine oil

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops and condition exacerbated.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidently swallowed get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

Do not mix with other chemical. Do not spray in the direction of the flame. Keep the space empty and keep food out of the fogging area.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

INSTRUCTIONS FOR USE SECTION

Spray adequate to the target area and allow the particles to drop and attach on the surface.

DOSAGE & ADMINISTRATION SECTION

Spray adequate to the target area and allow the particles to drop and attach on the surface.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display Panel and Drug FactsPrinciple Display Panel and Drug Facts

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
90014-00390014-003-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
HEXANEDIOLZIA319275IIACT
TRIETHYLENE GLYCOL3P5SU53360IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
THYMOL3J50XA376EACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
WHITE PINE OILHA5CX6676UIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ffa03f94-f3b7-fa54-e053-6294a90a5862e34154d2-20e1-2ff1-e053-2a95a90aec6f2023-07-03WarningsExact identifier
spl set id: e34154d2-20e1-2ff1-e053-2a95a90aec6f

Reported adverse events (FAERS/openFDA)#

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