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

Drug Facts4 L NDC: 90014-001-03

FLE ANTIBACTERIAL SOLUTION 
thymol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 90014-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 90014-001-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
2NDC: 90014-001-02500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
3NDC: 90014-001-034000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/202012/01/2022
Labeler - Moisture 22 Co., Ltd. (658294623)
Establishment
NameAddressID/FEIBusiness Operations
Moisture 22 Co., Ltd658294623manufacture(90014-001)

Revised: 7/2023
 

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