T.M. Green Life Antibacterial Hand Wipes by NP Korea / AJ Co., Ltd.

T.M. Green Life Antibacterial Hand Wipes by

Drug Labeling and Warnings

T.M. Green Life 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]

T.M. GREEN LIFE ANTIBACTERIAL HAND WIPES- benzalkonium chloride swab 
NP Korea

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.

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 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.

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

T.M. GREEN LIFE ANTIBACTERIAL HAND WIPES 
benzalkonium chloride swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79178-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0004 g  in 0.4 g

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: 79178-200-60	60 in 1 BOX	07/01/2020	01/19/2021
1		0.4 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 79178-200-20	20 in 1 BOX	07/01/2020	01/19/2021
2		0.4 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 79178-200-10	10 in 1 BOX	07/01/2020	01/19/2021
3		0.4 g in 1 PACKET; 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	07/01/2020	01/19/2021

Labeler - NP Korea (689007752)

Registrant - NP Korea (689007752)

Establishment
Name	Address	ID/FEI	Business Operations
AJ Co., Ltd.		631079605	manufacture(79178-200)

Establishment
Name	Address	ID/FEI	Business Operations
NP Korea		689007752	label(79178-200)

Revised: 1/2021

Document Id: b9d449ae-94e3-e5c9-e053-2a95a90abdd7

34390-5

Set id: a97b05f1-b00b-93e6-e053-2a95a90ab95d

Version: 3

Effective Time: 20210126