WET WIPES- benzalkonium chloride cloth 
Hangzhou ChunChi 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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81361-002 WET WIPES Benzalkonium chloride 0.1%

Active Ingredients

Benzalkonium Chloride 0.1%

PURPOSE

Antibacterial

USE

decreases bacteria on skin

Warning

For external use only
Do not use:Over large areas of the body ifyou are allergicto any ofthe ingredients.
When using this product do not get into eyes.If contactoccurs, rinse thoroughly with water.
Stop use and ask a doctor if irritation or rash develops andcontinues for more than 72 hours.

Keep out of reach of children.
For children under 2 years ask a doctor before use.For childrenuse under adult supervision.

Directions

Do not expose to direct sunlight, preferably place them in a coolplace. Do not use on furniture. Do not flush down toilets,dispose in trash recepticals.
Remove lid and open the seal. Pull up the corner of the center sheet, twist it and thread nrougnnichadrlose lid flap to retain moisture.

Inactive ingredients

Water, Propylene Glycol,Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate,Fragrance,Benzyl
Alcohol,Methylchloroisothiazolinone,Methylisothiazolinone, Tetrasodium EDTA, PEG-40 Hydrogenated Castor Oil, Centrimonium Chloride, Citric Acid,Aloe Vera Extract, Alphatocopherol Acetate (Vitamin E)

1

WET WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81361-002
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
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TOCOPHEROL (UNII: R0ZB2556P8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81361-002-012 in 1 CARTON10/14/2022
112 in 1 BOX
130 in 1 BAG
1150 g in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/14/2022
Labeler - Hangzhou ChunChi Touring Commodity CO., LTD. (549816514)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou ChunChi Touring Commodity CO., LTD.549816514manufacture(81361-002)

Revised: 10/2022
Document Id: eafd2305-1396-1f32-e053-2995a90aa0c8
Set id: eafd2305-1395-1f32-e053-2995a90aa0c8
Version: 1
Effective Time: 20221014
 
Hangzhou ChunChi Touring Commodity CO., LTD.