FDA.reportPublic FDA data

FLE Antibacterial Solution

Manufacturer
Moisture 22 Co., Ltd. | Moisture 22 Co., Ltd
Effective date
2022-12-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:43:27

Label at a glance#

ProductFLE Antibacterial Solution
Active ingredientTHYMOL
Label structure12 sections

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Thymol 0.3%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

For sanitizing to decrease bacteria.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

If you are allergic to any of the ingredients.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

If irritation or redness develops and condition exacerbated.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidently swallowed, get medical help or contact a Poison Control Center right away.

If pregnant or breastfeeding ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug Facts4 L NDC: 90014-001-03

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
90014-00190014-001-01, 90014-001-02, 90014-001-03

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
GLYCERINPDC6A3C0OXIACT
WHITE PINE OILHA5CX6676UIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
HEXANEDIOLZIA319275IIACT
THYMOL3J50XA376EACTIB
TRIETHYLENE GLYCOL3P5SU53360IACT
PHENOXYETHANOLHIE492ZZ3TIACT

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
ffa07b77-ec75-bb3d-e053-6394a90acec5abb448b8-4fde-795e-e053-2995a90a8c252023-07-03WarningsExact identifier
spl set id: abb448b8-4fde-795e-e053-2995a90a8c25

Reported adverse events (FAERS/openFDA)#

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