ANITISEPTIC SANITIZING WIPES- benzalkonium chloride cloth

Anitiseptic Sanitizing Wipes by

Drug Labeling and Warnings

Anitiseptic Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Jiaxing Qinya Sanitary Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USE

For hand washing to decrease
bacteria on skin
Recommended for repeated use.

Warning

For external use only
Do not use
■Intheeyes.
Stop use and ask doctor if:
Irritation and redness develops
■Condition persists for more than 72 hours

Keep out of reach of children. If
swallowed, get medical help or contact
a poison control center right away.

Directions

■Wet hands thoroughly with product
and allow to dry without wiping.

Inactive ingredients

Aloe Vera, Benzoic Acid,
Cocoamphodiacetate, Disodium, Glycerin,
Tea Tree (Melaleuca Alternifolica) Leaf Oil,
Menthol, Potassium Sorbate, Sodium
Citrate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANITISEPTIC SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 78601-002
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
MENTHOL (UNII: L7T10EIP3A)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 78601-002-04	180 in 1 BAG	06/05/2020
1		0.09477 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 78601-002-08	180 in 1 PAIL	06/05/2020
2		0.09477 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 78601-002-09	250 in 1 PAIL	06/05/2020
3		1.31625 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 78601-002-02	900 in 1 BAG	06/05/2020
4		4.7385 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 78601-002-05	250 in 1 BAG	06/05/2020
5		0.131625 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 78601-002-03	1200 in 1 BAG	06/05/2020
6		6.318 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 78601-002-06	80 in 1 BAG	06/05/2020
7		0.04212 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 78601-002-07	800 in 1 BAG	06/05/2020
8		0.4212 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 78601-002-10	20 in 1 BAG	06/05/2020
9		0.01053 g in 1 POUCH; Type 0: Not a Combination Product
10	NDC: 78601-002-01	10 in 1 BAG	06/05/2020
10		0.005265 g in 1 POUCH; Type 0: Not a Combination Product
11	NDC: 78601-002-11	160 in 1 PAIL	06/05/2020
11		0.08424 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	06/05/2020

Labeler - Jiaxing Qinya Sanitary Products Co., Ltd. (413135543)

Establishment
Name	Address	ID/FEI	Business Operations
Jiaxing Qinya Sanitary Products Co., Ltd.		413135543	manufacture(78601-002)