FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT- 75% ethanolgel gel 
SHANDONG LUGANGFUYOU MEDICAL 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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Protect from light and store ina cool, dry, venilatdplace.

Deionized water

Glycerine

Carbomer

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.

Ethanol

keep out of reach of children

Disinfection
Sterilization
No Rinseing

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.

label

FIBERLAY ETHANOL DISPOSABLE GEL DISINFECTANT 
75% ethanolgel gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53048-001
Route of AdministrationEXTRACORPOREAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code Fiberlay
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53048-001-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/22/2020
Labeler - SHANDONG LUGANGFUYOU MEDICAL CO., LTD (530388354)
Establishment
NameAddressID/FEIBusiness Operations
SHANDONG LUGANGFUYOU MEDICAL CO., LTD530388354manufacture(53048-001)

Revised: 5/2020
Document Id: a63933b3-1a85-2d15-e053-2995a90accf0
Set id: a63933b3-1a84-2d15-e053-2995a90accf0
Version: 1
Effective Time: 20200522
 
SHANDONG LUGANGFUYOU MEDICAL CO., LTD