INSTANT HAND SANITIZER - ORIGINAL- ethyl alcohol gel 
Great Lakes Wholesale & Marketing, 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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Active Ingredient                              Purpose

Ethyl Alcohol 62.0%......................Antimicrobial

XtraCare Instant Hand Sanitizer - Original

Kills 99.9% of Germs with Moisturizers & Vitamin E

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

USE: 

Warnings:

for external use only.

Flammable. Keep away from heat and flame.

Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Directions:

Inactive ingredients:

carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water, fragrance.

bottle label

package label

INSTANT HAND SANITIZER - ORIGINAL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-317
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 mL  in 53 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-317-022 in 1 PACKAGE
1NDC:64092-317-0153 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/05/2013
Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(64092-317)

Revised: 7/2013
Document Id: b2ce150f-c8b0-4c78-b6c9-37b02169710e
Set id: 41c1506a-da55-4bd0-b637-830e97930173
Version: 1
Effective Time: 20130705
 
Great Lakes Wholesale & Marketing, LLC