HAND SANITIZING WIPES- benzalkonium chloride cloth

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]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75127-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75127-005-01	200 in 1 CARTON	10/20/2020
1		10 in 1 BAG
1		4 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 75127-005-02	6 in 1 CARTON	10/20/2020
2		240 in 1 PAIL
2		4.04 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 75127-005-03	24 in 1 CARTON	10/20/2020
3		80 in 1 BAG
3		4.05 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 75127-005-04	4 in 1 CARTON	10/20/2020
4		800 in 1 BAG
4		4.05 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 75127-005-05	4 in 1 CARTON	10/20/2020
5		1200 in 1 BAG
5		4.05 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 75127-005-06	8 in 1 CARTON	10/20/2020
6		200 in 1 PAIL
6		4.05 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 75127-005-07	200 in 1 CARTON	10/20/2020
7		15 in 1 BAG
7		4 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 75127-005-08	40 in 1 CARTON	10/20/2020
8		50 in 1 BAG
8		4.04 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 75127-005-09	12 in 1 CARTON	10/20/2020
9		240 in 1 PAIL
9		4.04 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 75127-005-10	4 in 1 CARTON	10/20/2020
10		1500 in 1 BAG
10		4.04 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	10/20/2020

Labeler - Jurong Dongfa General Merchandise Co Ltd (528077612)

Establishment
Name	Address	ID/FEI	Business Operations
Jurong Dongfa General Merchandise Co Ltd		528077612	manufacture(75127-005)