75127-005 HAND SANITIZING WIPES 0.13% Benzalkonium chloride

HAND SANITIZING WIPES by

Drug Labeling and Warnings

HAND SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by Jurong Dongfa General Merchandise Co Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND 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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75127-005 HAND SANITIZING 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
Do not use in the eyes

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

Directions

Tear V notch located on top of the plastic bag.
Pull out the first wipe approximately 6 to 8 inches from the center
of the roll.
Place entire bag inside of center pull dispenser.
Thread the wipe through the opening on the dispenser
Close the lid of the dispenser. Wipe dispensing tension may be
adjusted on the top of the dispenser. Dispenser must be mounted
with wipes dispensing up.

Inactive ingredients

water (aqua), propylene glycol, aloe vera, polysorbate 20,
diazolideinyl urea, disodium cocoamphodiacetate, fragrance,
tetrasodium EDTA, citric acid, iodopropynyl butylcarbamate.

1

HAND SANITIZING WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 75127-005
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
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
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)  
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 75127-005-01200 in 1 CARTON10/20/2020
110 in 1 BAG
14 g in 1 POUCH; Type 0: Not a Combination Product
2NDC: 75127-005-026 in 1 CARTON10/20/2020
2240 in 1 PAIL
24.04 g in 1 POUCH; Type 0: Not a Combination Product
3NDC: 75127-005-0324 in 1 CARTON10/20/2020
380 in 1 BAG
34.05 g in 1 POUCH; Type 0: Not a Combination Product
4NDC: 75127-005-044 in 1 CARTON10/20/2020
4800 in 1 BAG
44.05 g in 1 POUCH; Type 0: Not a Combination Product
5NDC: 75127-005-054 in 1 CARTON10/20/2020
51200 in 1 BAG
54.05 g in 1 POUCH; Type 0: Not a Combination Product
6NDC: 75127-005-068 in 1 CARTON10/20/2020
6200 in 1 PAIL
64.05 g in 1 POUCH; Type 0: Not a Combination Product
7NDC: 75127-005-07200 in 1 CARTON10/20/2020
715 in 1 BAG
74 g in 1 POUCH; Type 0: Not a Combination Product
8NDC: 75127-005-0840 in 1 CARTON10/20/2020
850 in 1 BAG
84.04 g in 1 POUCH; Type 0: Not a Combination Product
9NDC: 75127-005-0912 in 1 CARTON10/20/2020
9240 in 1 PAIL
94.04 g in 1 POUCH; Type 0: Not a Combination Product
10NDC: 75127-005-104 in 1 CARTON10/20/2020
101500 in 1 BAG
104.04 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 finalpart333A10/20/2020
Labeler - Jurong Dongfa General Merchandise Co Ltd (528077612)
Establishment
NameAddressID/FEIBusiness Operations
Jurong Dongfa General Merchandise Co Ltd528077612manufacture(75127-005)

Revised: 2/2022
Document Id: d8c117af-226f-0df8-e053-2a95a90ad81d
Set id: b24d0e33-9809-b0ba-e053-2a95a90a6582
Version: 2
Effective Time: 20220224
 
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