ANTIBACTERIAL HAND SANITIZER- benzalkonium chloride gel 
Hangzhou Guoguang Touring Commodity Co., Ltd.

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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Hand Soap

Active Ingredient

Benzalkonium chloride 0.1%

Purpose

Antispetic

Use

for hand washing to decrease bacteria on skin

WARNINGS

For External use only-hands.

Avoid contact with eyes,in case of contact ,flush with water.

Keep out of direct sunlight

do not drink,not edible

keep out of reach of children

keep out of reach of children

Directions

press pump down to dispense liquid hand soap onto moistened hands,lather and rinse thoroughly

Inactive ingredients

aqua ,sodium laureth sulfate,cocamidopropyl betaine,disodium cocoamphodiacetate,cocamide MEDA,Glycerin,Aloe Barbadensis leaf juice,PEG-7 glyceryl cocoate,sodium chloride,citric acid ,disodium EDTA,tocopheryl acetate,methylisothiazolinone,lodopropynyl butylcarbamate

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ANTIBACTERIAL HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61312-007
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
COCAMIDE (UNII: 3YXD33R71G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL COCOATE (UNII: WVK1CT5994)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61312-007-0124 in 1 CARTON10/23/2016
1221 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/27/2014
Labeler - Hangzhou Guoguang Touring Commodity Co., Ltd. (526890634)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Guoguang Touring Commodity Co., Ltd.526890634manufacture(61312-007)

Revised: 1/2018
Document Id: 621793d7-3fec-5379-e053-2a91aa0a11c8
Set id: 3f7f37f9-ac16-65d3-e054-00144ff8d46c
Version: 3
Effective Time: 20180106
 
Hangzhou Guoguang Touring Commodity Co., Ltd.