FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT- 75% ethanolgel gel

Fiberlay Ethanol Disposable Gel Disinfectant by

Drug Labeling and Warnings

Fiberlay Ethanol Disposable Gel Disinfectant by is a Otc medication manufactured, distributed, or labeled by SHANDONG LUGANGFUYOU MEDICAL CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Protect from light and store ina cool, dry, venilatdplace.

INACTIVE INGREDIENT

Deionized water

Glycerine

Carbomer

INDICATIONS & USAGE

1.Hygiene hands: Take an aprpiate amount of hand dsinfectant on the palm of your hands, rub your hands together for 1 minute to dsinfect.
2. Surgical hands: After surgical hand washing take an apropiate amount of hand dsinfecant and evenly apply it to the skin of the hands, forearm and lower third of the upper arm for 3min.
3. Skin: Apply the skin surface evenly for 3min.

ACTIVE INGREDIENT

Ethanol

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

Disinfection
Sterilization
No Rinseing

WARNINGS

1.This is an extemal use dinfectant, please do not take titemallKeep itout of reach of children.

2. This product is fanmmable and away from fre sources.

3. Use with caution to those who are alergic to alcohol.

4. Protect from light and store ina cool, dry, venilatdplace.

5. Avoid couse withantagonist dugs.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT 
75% ethanolgel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53048-001
Route of Administration	EXTRACORPOREAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	375 mL  in 500 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code	Fiberlay
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53048-001-01	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	05/22/2020

Labeler - SHANDONG LUGANGFUYOU MEDICAL CO., LTD (530388354)

Establishment
Name	Address	ID/FEI	Business Operations
SHANDONG LUGANGFUYOU MEDICAL CO., LTD		530388354	manufacture(53048-001)