75109-517 Herclean Antibacterial Wipe 0.3% Benzalkonium Chloride

Herclean Antibacterial Wipe by

Drug Labeling and Warnings

Herclean Antibacterial Wipe 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]

HERCLEAN ANTIBACTERIAL WIPE- 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.

----------

75109-517 Herclean Antibacterial Wipe 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.
●Not recommended for repeated use.
●Dries in seconds.

Warning

For external use only.
When using this product 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.
Other information
.Lot No. Manufacture date and Expiration date can be found on package.

Inactive ingredients

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

HERCLEAN ANTIBACTERIAL WIPE 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75109-517
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
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)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75109-517-01	50 in 1 BOX	09/22/2020
1		3.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 75109-517-02	10 in 1 PACKAGE	09/22/2020
2		40.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 75109-517-03	25 in 1 PACKAGE	09/22/2020
3		101.25 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 75109-517-04	50 in 1 PACKAGE	09/22/2020
4		202.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 75109-517-05	80 in 1 PACKAGE	09/22/2020
5		324 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 75109-517-06	100 in 1 PACKAGE	09/22/2020
6		405 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 75109-517-07	100 in 1 CANISTER	09/22/2020
7		280 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 75109-517-08	100 in 1 CANISTER	09/22/2020
8		199.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 75109-517-09	800 in 1 PACKAGE	09/22/2020
9		1623.36 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 75109-517-10	1200 in 1 PACKAGE	09/22/2020
10		2435.04 g in 1 NOT APPLICABLE; 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	09/22/2020	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(75109-517)

Revised: 3/2022

Document Id: da7939ca-aae5-8ffb-e053-2a95a90a40c8

34390-5

Set id: aff224bf-5142-e64c-e053-2a95a90a5b09

Version: 3

Effective Time: 20220318

 

Kang