ANTISEPTIC HAND SANITIZER- alcohol liquid 
Hubei Fanjian Medical Product Co.,Ltd

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Antiseptic Hand Sanitizer

Drug Facts

Active ingredients

Ethyl alcohol 62% v/v

Purpose

`Antiseptic

Uses

Warnings

Flammable, keep away from fire or flame For external use only.

Do not use

in the eyes.

Stop use and ask a doctor if

  • imitation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands thoroughly with product and allow to dry without wiping.

Other information

Store at 15°to 25°C (59°to 77°F)

Inactive ingredients

Carbomer, propylene glycol, purified water, titanium dioxide

Package Labeling:

Label02Box1

ANTISEPTIC HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83165-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83165-000-001.03 mL in 1 BOTTLE; Type 0: Not a Combination Product01/07/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)01/07/2023
Labeler - Hubei Fanjian Medical Product Co.,Ltd (846385590)
Establishment
NameAddressID/FEIBusiness Operations
Hubei Fanjian Medical Product Co.,Ltd846385590manufacture(83165-000)

Revised: 11/2023
Document Id: 09ce7e86-3b8f-8e30-e063-6394a90a2d55
Set id: 9b4014a3-6296-4628-9cc6-b8d4ef4a25f3
Version: 3
Effective Time: 20231110
 
Hubei Fanjian Medical Product Co.,Ltd