ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 
Hebei Yihoucheng 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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ASSURED ANTIBACTERIAL WET WIPES

Active ingredient

Benzalkonium chloride 0.115%

Purpose

Antibacterial

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 Poison Control Center right away.

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 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,SD Alcohol 40,Propylene Glycol,Aloe Barbadensis Leaf,Potassium sorbate,Tocopherol,Quaternium 52,PEG-60 Lanolin,Citric Acid,Disodium EDTA

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ANTIBACTERIAL WET WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59575-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ALCOHOL (UNII: 3K9958V90M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
QUATERNIUM-22 (UNII: MXO138JCBP)  
PEG-60 CASTOR OIL (UNII: VXP26NM2XX)  
CITRACONIC ACID (UNII: 0RQ6CXO9KD)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59575-501-033 in 1 BAG
110 in 1 PACKAGE
13 g in 1 POUCH
2NDC:59575-501-0420 in 1 BOX
21 in 1 PACKAGE
23 g in 1 POUCH
3NDC:59575-501-0110 in 1 PACKAGE
33 g in 1 POUCH
4NDC:59575-501-021 in 1 PACKAGE
43 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/16/2013
Labeler - Hebei Yihoucheng Commodity Co.,Ltd. (529305333)
Establishment
NameAddressID/FEIBusiness Operations
Hebei Yihoucheng Commodity Co.,Ltd.529305333manufacture(59575-501)

Revised: 8/2013
Document Id: 6ecc1ca0-6f7b-4d6d-bb67-841077457c30
Set id: 8d635665-05b2-488d-a0cc-e0081e8adb71
Version: 3
Effective Time: 20130824
 
Hebei Yihoucheng Commodity Co.,Ltd.