INSTANT HAND SANITIZER - COCOA BUTTER- 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 IngredientPurpose

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

Health Care Instant Hand Sanitizer - Ice Clear - Extra Enriched with Vitamin E Bead & Aloe

Kills 99.9% of Germs without water or towels!

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:

aloe vera leaf juice, carbomer, glycerin, propylene glycol, tocopheryl acetate (vitamin E), triethanolamine, water.

Other information:

bottle label

INSTANT HAND SANITIZER - COCOA BUTTER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-315
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL147 mL  in 237 mL
Inactive Ingredients
Ingredient NameStrength
COCOA BUTTER (UNII: 512OYT1CRR)  
CARBOMER HOMOPOLYMER TYPE B (UNII: HHT01ZNK31)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-315-01236 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(64092-315)

Revised: 7/2013
Document Id: b577ddec-a10d-4f76-be71-fcf2344e67bd
Set id: 961e9ef6-973d-4478-a2d3-f2f66af4537b
Version: 1
Effective Time: 20130705
 
Great Lakes Wholesale & Marketing, LLC