SANITIZING WIPES- benzalkonium chloride cloth 
Jurong Dongfa General Merchandise 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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75127-101 SANITIZING ALCOHOL FREE WIPES 0.13% Benzalkonium chloride

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USE

●For hand sanitizing to decrease bacteria on the skin.
●Apply topically to the skin to help prevent cross contamination.
●Recommended for repeated use.
●Dries in seconds.

Warning

For external use only
May irritate eyes

●Keep out of reach of children unless under adult supervision.

Directions

.Tear V notch on top of plastic bag.
. Pull first wipe from the center of roll up through opening of bag. Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.
- Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Inactive ingredients

Water (Aqua),Propylene Glycol,Polysorbate 20,Disodium
Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate,Aloe Barbadensis Leaf Juice,TocopheryI Acetate (Vitamin E), Fragrance.

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SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75127-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75127-101-014 in 1 CARTON12/10/2020
1800 in 1 BAG
14 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2NDC:75127-101-0212 in 1 CARTON12/10/2020
250 in 1 PAIL
24 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3NDC:75127-101-032 in 1 CARTON12/10/2020
3800 in 1 BAG
34 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A12/10/2020
Labeler - Jurong Dongfa General Merchandise Co Ltd (528077612)
Establishment
NameAddressID/FEIBusiness Operations
Jurong Dongfa General Merchandise Co Ltd528077612manufacture(75127-101)

Revised: 2/2021
Document Id: ba55d618-f32f-e6db-e053-2a95a90aeefd
Set id: b64f0417-c6a8-451e-e053-2a95a90ae338
Version: 3
Effective Time: 20210202
 
Jurong Dongfa General Merchandise Co Ltd