NDC 80395-204 Spot Care Green One

Alcohol, Benzyl Alcohol

NDC Product Code 80395-204

NDC 80395-204-01

Package Description: 30 mL in 1 BOTTLE

NDC Product Information

Spot Care Green One with NDC 80395-204 is a a human over the counter drug product labeled by Leejiham. The generic name of Spot Care Green One is alcohol, benzyl alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Leejiham

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Spot Care Green One Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BENZYL ALCOHOL .05 g/100mL
  • ALCOHOL 2 mL/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Leejiham
Labeler Code: 80395
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 09-02-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Spot Care Green One Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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

* Please review the disclaimer below.