NDC 90028-201 Oregano Essence

Origanum Vulgare Leaf Extract

NDC Product Code 90028-201

NDC 90028-201-01

Package Description: 120 g in 1 BOTTLE

NDC Product Information

Oregano Essence with NDC 90028-201 is a a human over the counter drug product labeled by Jmb Koseu Line Co., Ltd. The generic name of Oregano Essence is origanum vulgare leaf extract. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Jmb Koseu Line Co., Ltd

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.

Oregano Essence 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.

  • OREGANO 6.94 g/100g

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.

  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • OREGANO LEAF OIL (UNII: 7D0CGR40U1)
  • ROSEMARY OIL (UNII: 8LGU7VM393)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

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: Jmb Koseu Line Co., Ltd
Labeler Code: 90028
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-03-2020 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.

Oregano Essence Product Label Images

Oregano Essence 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

Origanum Vulgare Leaf Extract 6.94%

Purpose

Skin protectant

Use

Helps moisturize skin by supplying moisture to the skin.

Warnings

  • For external use only.Do not use on open skin wound.In case of contact with eyes, rinse eyes thoroughly with waterStore away from direct sunlight.

  • Keep out of reach of children.

If irritation or rash occurs stop use and ask a doctor.

Directions

Take an appropriate amount and apply gently as if massaging according to the skin texture, then tap it for absorption.

Other Information

Store between 15-30℃

Inactive Ingredients

Water, Butylene Glycol, 1,2-Hexanediol, Sodium Hyaluronate, Origanum Vulgare Leaf Oil(250ppm), Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydro genated Lecithin, Caprylic/Capric Triglyceride, Ammonium Acryloyldimethyltaurate/VP Copoly mer, Acrylates/C10-30 Alkyl Acrylate Crosspoly mer, Polyvinyl Alcohol, Ethylhexylglycerin

* Please review the disclaimer below.