SANITIZING WIPES- benzalkonium chloride cloth

SANITIZING WIPES by

Drug Labeling and Warnings

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
May irritate eyes

●Keep out of reach of children unless under adult supervision.

Directions

.Tear V notch on top of plastic bag.
. Pull first wipe from the center of roll up through opening of bag. Thread first wipe through the dispensing nozzle in lid of floor stand or dispenser.
- Close dipenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes dispensing up.

Inactive ingredients

Water (Aqua),Propylene Glycol,Polysorbate 20,Disodium
Cocoamphodiacetate, Citric Acid, Disodium EDTA, Potassium Sorbate,Aloe Barbadensis Leaf Juice,TocopheryI Acetate (Vitamin E), Fragrance.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75127-101
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
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)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75127-101-01	4 in 1 CARTON	12/10/2020
1		800 in 1 BAG
1		4 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 75127-101-02	12 in 1 CARTON	12/10/2020
2		50 in 1 PAIL
2		4 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 75127-101-03	2 in 1 CARTON	12/10/2020
3		800 in 1 BAG
3		4 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	12/10/2020

Labeler - Jurong Dongfa General Merchandise Co Ltd (528077612)

Establishment
Name	Address	ID/FEI	Business Operations
Jurong Dongfa General Merchandise Co Ltd		528077612	manufacture(75127-101)