ANTISEPTIC SANITIZING WIPES- benzalkonium chloride swab

ANTISEPTIC SANITIZING WIPES by

Drug Labeling and Warnings

ANTISEPTIC SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by HANGZHOU CLEAN NONWOVEN 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
■In the eyes
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
allowto dry without wiping.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC SANITIZING WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75714-002
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
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
TEA TREE OIL (UNII: VIF565UC2G)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75714-002-01	4 in 1 CARTON	03/21/2020
1		900 in 1 BAG
1		4.7 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 75714-002-02	160 in 1 CARTON	03/21/2020
2		10 in 1 BAG
2		4.7 g in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 75714-002-03	4 in 1 CARTON	03/21/2020
3		1200 in 1 BAG
3		3.7 g in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 75714-002-04	4 in 1 CARTON	03/21/2020
4		180 in 1 BAG
4		4.7 g in 1 POUCH; Type 0: Not a Combination Product
5	NDC: 75714-002-05	4 in 1 CARTON	03/21/2020
5		250 in 1 BAG
5		4.7 g in 1 POUCH; Type 0: Not a Combination Product
6	NDC: 75714-002-06	12 in 1 CARTON	03/21/2020
6		80 in 1 BAG
6		4.7 g in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 75714-002-07	2 in 1 CARTON	03/21/2020
7		800 in 1 BAG
7		4.7 g in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 75714-002-08	2 in 1 CARTON	03/21/2020
8		1000 in 1 BAG
8		4.7 g in 1 POUCH; Type 0: Not a Combination Product
9	NDC: 75714-002-09	160 in 1 CARTON	03/20/2020
9		100 g in 1 BOTTLE; Type 0: Not a Combination Product
10	NDC: 75714-002-10	40 in 1 CARTON	03/20/2020
10		500 g in 1 BOTTLE; 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	03/20/2020

Labeler - HANGZHOU CLEAN NONWOVEN CO.,LTD (560795987)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU CLEAN NONWOVEN CO.,LTD		560795987	manufacture(75714-002)