Moisture 001-01, 001-02 and 001-03

FLE Antibacterial Solution by

Drug Labeling and Warnings

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

Drug Details [pdf]

FLE ANTIBACTERIAL SOLUTION- 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 001-01, 001-02 and 001-03

Active Ingredient(s)

Thymol 0.3%

Purpose

Antibacterial

Use

For sanitizing to decrease bacteria.

Warnings

For external use only.

Do not use

If you are allergic to any of the ingredients.

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.

If irritation or redness develops and condition exacerbated.

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

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

Other information

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

Inactive ingredients

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

Package Label - Principal Display Panel

4 L NDC: 90014-001-03

FLE ANTIBACTERIAL SOLUTION 
thymol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 90014-001
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
GLYCERIN (UNII: PDC6A3C0OX)
WHITE PINE OIL (UNII: HA5CX6676U)
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HEXANEDIOL (UNII: ZIA319275I)
TRIETHYLENE GLYCOL (UNII: 3P5SU53360)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 90014-001-01	50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2020
2	NDC: 90014-001-02	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2020
3	NDC: 90014-001-03	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	07/31/2020	12/01/2022

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

Establishment
Name	Address	ID/FEI	Business Operations
Moisture 22 Co., Ltd		658294623	manufacture(90014-001)

Revised: 7/2023

Document Id: ffa07b77-ec75-bb3d-e053-6394a90acec5

34390-5

Set id: abb448b8-4fde-795e-e053-2995a90a8c25

Version: 4

Effective Time: 20230703