LIQUID HAND CLEANSE- triclosan 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

Triclosan 0.2%......................Antiseptic

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.

bottle label

LIQUID HAND CLEANSE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64092-316
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN10 mg  in 500 mg
Inactive Ingredients
Ingredient NameStrength
CETETH-7 (UNII: 4ST6952Q67)  
ETHYL SULFATE (UNII: P3LK0HF3B7)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DIETHANOLAMINE (UNII: AZE05TDV2V)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
OCTHILINONE (UNII: 4LFS24GD0V)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64092-316-01500 mg 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(64092-316)

Revised: 7/2013
Document Id: 629dd3c1-50e2-4cae-b675-97e504096e60
Set id: 715a4dc0-2995-4ffe-bbba-382dc155c171
Version: 1
Effective Time: 20130705
 
Great Lakes Wholesale & Marketing, LLC