ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 
ZHEJIANG GREENFACE HOUSEWARES 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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ANTIBACTERIAL WET WIPES 587

Active ingredient

Benzalkonium chloride 0.1%

Purpose

Antibacterial

Use

Use decreases bacteria on skin.

Warnings

For external use only.

Do not use over large areas of the body if you are allergic to any of the ingredients.

When using this product do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.

Keep out of reach of children. If swallowed, get medical help or contact a PoisonControlCenterright away.

Keep out of reach of children

Keep out of reach of children. If swallowed, get

medical help or contact aPoisonControlCenter

right away.

Directions

For adults and children of 2 years and over use on hands and face to clean and refresh, allow skin to air dry.

For children under 2 years ask a doctor before use.

water, propylene glycol, cocamidopropyl betaine, polyaminopropyl biguanide, glycine, disodium EDTA, aloe barbadensis leaf extract, tocopheryl acetate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, PEG-40 hydrogenated castor oil.

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ANTIBACTERIAL WET WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-587
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
GLYCINE (UNII: TE7660XO1C)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42255-587-013 in 1 BAG01/08/2018
110 in 1 PACKAGE
12.75 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:42255-587-0220 in 1 BAG01/08/2018
21 in 1 PACKAGE
23 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/17/2013
Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
Establishment
NameAddressID/FEIBusiness Operations
ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-587)

Revised: 1/2018
Document Id: 624072ff-e104-d357-e053-2991aa0ad313
Set id: 15dcdcf0-1ae3-4628-90fe-609da0a9b4b5
Version: 2
Effective Time: 20180108
 
ZHEJIANG GREENFACE HOUSEWARES CO., LTD.