FLE Disinfectant by Moisture 22 Co., Ltd. Moisture 22 003-03

FLE Disinfectant by

Drug Labeling and Warnings

FLE Disinfectant by is a Otc medication manufactured, distributed, or labeled by Moisture 22 Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FLE DISINFECTANT- thymol liquid 
Moisture 22 Co., Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Moisture 22 003-03

Thymol 0.3%

Antifungal

For External use only.

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

For sanitizing to decrease bacteria.

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

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

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

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

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.

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

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

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

FLE DISINFECTANT 
thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90014-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HEXANEDIOL (UNII: ZIA319275I)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
WHITE PINE OIL (UNII: HA5CX6676U)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90014-003-03	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/07/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/07/2022	12/01/2022

Labeler - Moisture 22 Co., Ltd. (658294623)

Establishment
Name	Address	ID/FEI	Business Operations
Moisture 22 Co., Ltd.		658294623	manufacture(90014-003)

Revised: 7/2023

Document Id: ffa03f94-f3b7-fa54-e053-6294a90a5862

34390-5

Set id: e34154d2-20e1-2ff1-e053-2a95a90aec6f

Version: 3

Effective Time: 20230703