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 potenially 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 of 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

10 mL NDC: 74728-070-40

EMURGENT USA HAND SANITIZER 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 74728-070(NDC: 75029-125)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
RAPIDGEL EZ1 (UNII: 33JH4A7R2K)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 74728-070-40	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/12/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/12/2021	03/31/2022

Labeler - EmUrgent USA LLC (117473717)

Registrant - EmUrgent USA LLC (117473717)

Establishment
Name	Address	ID/FEI	Business Operations
EmUrgent USA LLC		117473717	repack(74728-070) , relabel(74728-070)

Revised: 3/2022

Document Id: db8b8cb9-32c8-ec97-e053-2a95a90a02b1

34390-5

Set id: bb29b37a-3ef3-bab2-e053-2995a90a4753

Version: 3

Effective Time: 20220331