ANTISEPTIC SANITIZING WIPES- benzalkonium chloride cloth

ANTISEPTIC SANITIZING WIPES by

Drug Labeling and Warnings

ANTISEPTIC SANITIZING WIPES by is a Otc medication manufactured, distributed, or labeled by HANGZHOU WIPEX NONWOVENS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13%

Purpose

Antiseptic

USE

Use for hand sanitizing to decrease bacteria on the 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 allow to dry without wiping.

Inactive ingredients

Water,Glycerin, Disodium
Cocoamphodiacetate,
Phenoxyethanol,Benzoic Acid
Polysorbate,Potassium Sorbate
Aloe barbadensia Leaf juice,
Melaleuca Alternifolia (Tea Tree) Leaf Oil,
Menthol, Sodium Citrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ANTISEPTIC SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79294-001
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
MENTHOL (UNII: L7T10EIP3A)
TEA TREE OIL (UNII: VIF565UC2G)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79294-001-01	160 in 1 CARTON	07/30/2020
1		10 in 1 BAG
1		60 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
2	NDC: 79294-001-02	4 in 1 CARTON	07/30/2020
2		1200 in 1 BAG
2		4700 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
3	NDC: 79294-001-03	48 in 1 CARTON	07/30/2020
3		50 in 1 BAG
3		237 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
4	NDC: 79294-001-04	24 in 1 CARTON	07/30/2020
4		80 in 1 CANISTER
4		337 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
5	NDC: 79294-001-05	24 in 1 CARTON	07/30/2020
5		100 in 1 CANISTER
5		540 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
6	NDC: 79294-001-06	12 in 1 CARTON	07/30/2020
6		180 in 1 CANISTER
6		1120 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
7	NDC: 79294-001-07	12 in 1 CARTON	07/30/2020
7		220 in 1 CANISTER
7		450 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
8	NDC: 79294-001-08	4 in 1 CARTON	07/30/2020
8		800 in 1 BAG
8		1638 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
9	NDC: 79294-001-09	4 in 1 CARTON	07/30/2020
9		900 in 1 BAG
9		1842 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
10	NDC: 79294-001-10	4 in 1 CARTON	07/30/2020
10		1500 in 1 BAG
10		3071 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	07/30/2020

Labeler - HANGZHOU WIPEX NONWOVENS CO., LTD. (421323516)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU WIPEX NONWOVENS CO., LTD.		421323516	manufacture(79294-001)