ANTIBACTERIAL MOIST WIPES- benzalkonium chloride swab 
JIANGSU TERRA MEDICAL TECHNOLOGY 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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Active ingredient

Benzalkonium chloride  0.1%

Purpose

antibacterial

Use

decreases bacteria on skin

Warnings

for external use only

over large areas of the body 

if you are allergic to ay of the ingredients

When using this product avoid contact with eyes and face.

if contact occurs,flush throughly with water


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

Keep out of reach of children

Keep out of reach of children ,If swallowed ,get medical help or contact a Poison Control Center right away.

Directions

for adults and children of 2 years and over.

children under 2 years ask a doctor before use

allow to dry without wiping

water ,sodium lauryl sulfate,fragrance,2-bromo-2-nitropropane-1,3-diol,aloe barbadensis leaf extract,disodium EDTA,triethanolamine,glycerin,tocopheryl acetate.

image description

ANTIBACTERIAL MOIST WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69733-558
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)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
2-BROMO-2-NITROETHANOL (UNII: FA22WV2B2Z)  
2-METHYL-2-PROPYLPROPANE-1,3-DIOL (UNII: YLM5KRU0P4)  
ALOE ARBORESCENS LEAF (UNII: 09TD8L5SQV)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
TRIETHANOLAMINE BENZOATE (UNII: M3EN4GC19W)  
GLYCERIN (UNII: PDC6A3C0OX)  
TOCOPHERYL RETINOATE (UNII: 0WN694NBMM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69733-558-0220 in 1 PACKAGE
10.00297 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 finalpart333E04/15/2015
Labeler - JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD (421340473)
Establishment
NameAddressID/FEIBusiness Operations
JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD421340473manufacture(69733-558)

Revised: 5/2015
Document Id: 9168a381-ddef-4459-a994-4cc2e449dc83
Set id: 9e87277c-d4e8-41f2-9ca7-9c7abc97e0b1
Version: 5
Effective Time: 20150504
 
JIANGSU TERRA MEDICAL TECHNOLOGY CO LTD