EmUrgent USA Hand Sanitizer by EmUrgent USA LLC Hand Sanitizer

EmUrgent USA Hand Sanitizer by

Drug Labeling and Warnings

EmUrgent USA Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by EmUrgent USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EMURGENT USA HAND SANITIZER- alcohol gel 
EmUrgent USA LLC

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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Hand Sanitizer

Active Ingredient(s)

Alcohol 70% v/v

Purpose

Antiseptic

Use

Hand sanitizer to help to reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

  • on children less than 2 months of age
  • on open skin wounds

When using

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out or reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Glycerin, isopropyl alcohol, PEG-6 (and) AMP-acrylates/-vinyl isodecanoate crosspolymer, purified water

Package label-principal display panel

60 ml gel label60 mL NDC: 74728-070-30

EMURGENT USA HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 74728-070(NDC: 75029-125)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 74728-070-3060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/05/202003/31/2022
Labeler - EmUrgent USA LLC (117473717)
Registrant - EmUrgent USA LLC (117473717)
Establishment
NameAddressID/FEIBusiness Operations
EmUrgent USA LLC117473717repack(74728-070) , relabel(74728-070)

Revised: 3/2022
 

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