ALCOSM ANTIBACTERIAL WIPES- benzalkonium chloride cloth

Alcosm Antibacterial wipes by

Drug Labeling and Warnings

Alcosm 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]

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. Flammable, keep away from fire or flame.
When using this product keep out of eyes, ears, and mouth. In case of eye contact, flush thoroughly with water.
Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away.

Directions

Remove lid. Pull wipe from center of roll and thread through opening in lid. Do not push finger through
opening. Replace lid, pull wipe up and then out at 45° angle. Next wipe dispenses automatically. Close lid to retain moisture.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALCOSM ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75109-507
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: 75109-507-01	600 in 1 CARTON	07/05/2020
1		1 in 1 PACKAGE
1		5.5 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 75109-507-02	100 in 1 CARTON	07/05/2020
2		10 in 1 PACKAGE
2		58 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 75109-507-03	24 in 1 CARTON	07/05/2020
3		50 in 1 PACKAGE
3		270 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 75109-507-04	16 in 1 CARTON	07/05/2020
4		80 in 1 PACKAGE
4		430 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 75109-507-05	16 in 1 CARTON	07/05/2020
5		100 in 1 PACKAGE
5		530 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 75109-507-06	12 in 1 CARTON	07/05/2020
6		75 in 1 CANISTER
6		420 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 75109-507-07	12 in 1 CARTON	07/05/2020
7		150 in 1 CANISTER
7		420 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 75109-507-08	12 in 1 CARTON	07/05/2020
8		240 in 1 CANISTER
8		760 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 75109-507-09	2 in 1 CARTON	07/05/2020
9		350 in 1 CANISTER
9		2768 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	07/05/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Kangna (Zhejiang) Medical Supplies Co., Ltd.		554530173	manufacture(75109-507)