INSTANT HAND SANITIZER - ICE CLEAR- 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

package label

INSTANT HAND SANITIZER - ICE CLEAR 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-313
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
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:64092-313-022 in 1 PACKAGE
1NDC:64092-313-0160 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(64092-313)

Revised: 7/2013
Document Id: 72a597ac-a286-4922-9367-cf55750547a1
Set id: 6a9564a8-ad0e-4e28-b216-36b84be5c629
Version: 1
Effective Time: 20130705
 
Great Lakes Wholesale & Marketing, LLC