SPOT CARE GREEN ONE by Leejiham 80395-204

SPOT CARE GREEN ONE by

Drug Labeling and Warnings

SPOT CARE GREEN ONE by is a Otc medication manufactured, distributed, or labeled by Leejiham. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPOT CARE GREEN ONE- alcohol, benzyl alcohol liquid 
Leejiham

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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80395-204

Active ingredient

Alcohol 2%

Glycerin 0.01%

Benzyl Alcohol 0.05%

Purpose

​Skin Protectant

Uses

Water type ampule for calming skin irritation and blemish-prone skin and even relieving acne skin.

Directions

Soak cotton pad and apply over the face except eye and lip areas after using Blue One.

Inactive ingredients

Water, Alcohol, Sodium PCA, Butylene Glycol, Sodium Lactate, Dipotassium Glycyrrhizate, Methyl Gluceth-20, Potassium Chloride, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Arginine, Betaine, Ethylhexylglycerin, Sorbitol, Sodium Hyaluronate, Portulaca Oleracea Extract, Glycine, Glutamic Acid, Alanine, Lysine, Threonine, Proline, Glycyrrhiza Uralensis (Licorice) Root Extract, Silkworm Extract, Morus Alba Bark Extract, Opuntia Coccinellifera Fruit Extract, Diospyros Kaki Leaf Extract, Rehmannia Glutinosa Root Extract, Cornus Officinalis Fruit Extract, Dioscorea Japonica Root Extract, Alisma Orientale Tuber Extract, Poria Cocos Sclerotium Extract,Paeonia Suffruticosa Root Extract, Chamomilla Recutita (Matricaria) Flower Water, Artemisia Princeps Leaf Extract, Benzyl Alcohol, Chlorphenesin

Warnings

For external use only

Stop use and ask a physician

if skin irritation and redness occurs more than 72 hours.

Do not use

on damaged or broken skin

Keep out of reach of children

If swallowed, get medical help right away.

Other information

Protect this product from direct sun and excessive heat

Package Label

SPOT CARE GREEN ONE 
alcohol, benzyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80395-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH)	BENZYL ALCOHOL	0.05 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	2 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)
CHLORPHENESIN (UNII: I670DAL4SZ)
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SODIUM LACTATE (UNII: TU7HW0W0QT)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLUTAMIC ACID (UNII: 3KX376GY7L)
SORBITOL (UNII: 506T60A25R)
SERINE (UNII: 452VLY9402)
GLYCINE (UNII: TE7660XO1C)
ALANINE (UNII: OF5P57N2ZX)
LYSINE (UNII: K3Z4F929H6)
BETAINE (UNII: 3SCV180C9W)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
ARGININE (UNII: 94ZLA3W45F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PURSLANE (UNII: M6S840WXG5)
PROLINE (UNII: 9DLQ4CIU6V)
GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)
BOMBYX MORI LARVA (UNII: 1WYM0QWX33)
MORUS ALBA BARK (UNII: 7O71A48NDP)
OPUNTIA COCHENILLIFERA FRUIT (UNII: 838ZTK02KH)
DIOSPYROS KAKI LEAF (UNII: Q71GF9OBNO)
REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)
CORNUS OFFICINALIS FRUIT (UNII: 23NL8NQ187)
ALISMA PLANTAGO-AQUATICA SUBSP. ORIENTALE ROOT (UNII: 555C7I140L)
PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)
THREONINE (UNII: 2ZD004190S)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
FU LING (UNII: XH37TWY5O4)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
ASIAN GINSENG (UNII: CUQ3A77YXI)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80395-204-01	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020	12/31/2021
2	NDC: 80395-204-02	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/02/2020	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/02/2020	12/31/2021

Labeler - Leejiham (695004132)

Registrant - Leejiham (695004132)

Establishment
Name	Address	ID/FEI	Business Operations
Leejiham		695004132	manufacture(80395-204)

Revised: 6/2022

Document Id: e173c1a3-69eb-9374-e053-2a95a90a4b84

34390-5

Set id: ae510c7f-f209-6bea-e053-2995a90a90d1

Version: 4

Effective Time: 20220614