ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
Kangna (Zhejiang) Medical Supplies 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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75109-504 Antibacterial Wipes 0.3% Benzalkonium Chloride

Active Ingredient

Benzalkonium Chloride 0.3%

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 or contact the eyes.
" Stop use and ask a doctor if too much skin irritation or
sensitivity develops or increases.

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

Directions

●Gently pull back resealable label, remove and use wipe
as required.
， Reseal back after use.

Inactive ingredients

Water, Phenoxyethanol, DMDM Hydantoin, Ethylparaben,
Methylparaben, Polysorbate 20, Fragrance, Disodium EDTA,
Sodium Citrate, Cetylpyridinium Chloride.

1

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-504
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
WATER (UNII: 059QF0KO0R)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLPARABEN (UNII: 14255EXE39)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75109-504-0150 in 1 BAG06/21/2020
15.5 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:75109-504-0210 in 1 PACKAGE06/21/2020
258 g in 1 POUCH; Type 0: Not a Combination Product
3NDC:75109-504-0325 in 1 PACKAGE06/21/2020
3135 g in 1 POUCH; Type 0: Not a Combination Product
4NDC:75109-504-0450 in 1 PACKAGE06/21/2020
4270 g in 1 POUCH; Type 0: Not a Combination Product
5NDC:75109-504-0580 in 1 PACKAGE06/21/2020
5430 g in 1 POUCH; Type 0: Not a Combination Product
6NDC:75109-504-06100 in 1 PACKAGE06/21/2020
6530 g in 1 POUCH; Type 0: Not a Combination Product
7NDC:75109-504-0770 in 1 CANISTER06/21/2020
7387.845 g in 1 POUCH; Type 0: Not a Combination Product
8NDC:75109-504-08100 in 1 CANISTER06/21/2020
8316.5 g in 1 POUCH; Type 0: Not a Combination Product
9NDC:75109-504-09300 in 1 CANISTER06/21/2020
9849.5 g in 1 POUCH; Type 0: Not a Combination Product
10NDC:75109-504-10800 in 1 BAG06/21/2020
101543.43 g in 1 POUCH; Type 0: Not a Combination Product
11NDC:75109-504-111200 in 1 BAG06/21/2020
112300.15 g in 1 POUCH; Type 0: Not a Combination Product
12NDC:75109-504-121500 in 1 BAG06/21/2020
122867.69 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 finalpart333A06/21/2020
Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
Establishment
NameAddressID/FEIBusiness Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-504)

Revised: 1/2022
Document Id: d5873b92-2a55-cb36-e053-2995a90aef93
Set id: a8a1846f-1f3e-cdcb-e053-2a95a90ae647
Version: 3
Effective Time: 20220114
 
Kangna (Zhejiang) Medical Supplies Co., Ltd.