NPKLEAN ANTIBACTERIAL HAND WIPES- benzalkonium chloride swab

NPklean Antibacterial Hand Wipes by

Drug Labeling and Warnings

NPklean Antibacterial Hand Wipes by is a Otc medication manufactured, distributed, or labeled by NP Korea, AJ Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.1% ….………………………Antimicrobial

Purpose

Antimicrobial, Hand Wipes

Use

• To help reduce bacteria on the skin.
• For use when soap and water are not available.

Warnings

For external use only.

Do not use

• Do not use if you are allergic to any of the ingredients.
• Do not get into eyes. In case of contact, rinse eyes thoroughly with water.
• Avoid contact with broken skin.
• Do not inhale or ingest.

WHEN USING

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years and over;

 Apply wipe thoroughly to hands.

 Allow to dry without wiping.

 Children under 2 years, ask a doctor before use.

Other information

• Store at room temperature.
• Keep away from direct sunlight.
• Dispose of used wipes in trash receptacle after use.
• Do not flush.

Inactive ingredients

Water, Propylene Glycol, Phenoxyethanol, Glycerin, Sodium Benzoate, Sodium Citrate, Disodium EDTA, Polysorbate 20, Citric

Acid, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate.

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

NPKLEAN ANTIBACTERIAL HAND WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79178-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1   in 100

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79178-101-60	60 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2020
2	NDC: 79178-101-20	20 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2020
3	NDC: 79178-101-10	10 in 1 PACKAGE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - NP Korea (689007752)

Registrant - NP Korea (689007752)

Establishment
Name	Address	ID/FEI	Business Operations
AJ Co., Ltd.		631079605	manufacture(79178-101)

Establishment
Name	Address	ID/FEI	Business Operations
NP Korea		689007752	label(79178-101)