75109-505 Antibacterial Wipes 0.3% Benzalkonium Chloride

Antibacterial wipes by

Drug Labeling and Warnings

Antibacterial wipes by is a Otc medication manufactured, distributed, or labeled by Kangna (Zhejiang) Medical Supplies Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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75109-505 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.

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75109-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	LEMON	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75109-505-01	50 in 1 BOX	06/21/2020
1		5.5 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 75109-505-02	10 in 1 PACKAGE	06/21/2020
2		58 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 75109-505-03	25 in 1 PACKAGE	06/21/2020
3		135 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 75109-505-04	50 in 1 PACKAGE	06/21/2020
4		270 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 75109-505-05	80 in 1 PACKAGE	06/21/2020
5		430 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 75109-505-06	100 in 1 PACKAGE	06/21/2020
6		530 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 75109-505-07	100 in 1 CANISTER	06/21/2020
7		321.5 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 75109-505-08	300 in 1 CANISTER	06/21/2020
8		849.5 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 75109-505-09	800 in 1 BAG	06/21/2020
9		1543.43 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 75109-505-10	1200 in 1 BAG	06/21/2020
10		2300.15 g in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 75109-505-11	1500 in 1 BAG	06/21/2020
11		2867.69 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/21/2020	03/18/2022

Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(75109-505)

Revised: 3/2022

Document Id: da76019e-eb6d-a0cc-e053-2995a90a605b

34390-5

Set id: a8a3f23b-d847-ea06-e053-2a95a90a0584

Version: 3

Effective Time: 20220317

 

Kang