INSTANT HAND SANITIZER ALOE VERA- 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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Ethyl Alcohol 62.0%  ..................... Antimicrobial

XtraCare Instant Hand Sanitizer Aloe Vera

kills 99.9% of germs

with Moisturizers & Aloe Vera

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

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

water, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, titanium dioxide, aloe barbadensis leaf juice.

package label

INSTANT HAND SANITIZER ALOE VERA 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146 mL  in 236 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-312-01236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E07/03/2013
Labeler - Great Lakes Wholesale & Marketing, LLC (361925498)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(64092-312)

Revised: 7/2013
Document Id: 4f1b2435-8b85-4277-8d30-e6786eaaf143
Set id: 18a43449-b04b-4a66-9de0-0ccace9a98d7
Version: 1
Effective Time: 20130703
 
Great Lakes Wholesale & Marketing, LLC