NDC 74997-0023 W.skin Treemon Toner

Melaleuca Alternifolia (tea Tree) Extract

NDC Product Code 74997-0023

NDC 74997-0023-1

Package Description: 300 mL in 1 BOTTLE

NDC Product Information

W.skin Treemon Toner with NDC 74997-0023 is a a human over the counter drug product labeled by J&j Company. The generic name of W.skin Treemon Toner is melaleuca alternifolia (tea tree) extract. The product's dosage form is liquid and is administered via topical form.

Labeler Name: J&j Company

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.

W.skin Treemon Toner 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.

  • MELALEUCA ALTERNIFOLIA LEAF 1 g/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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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.

Product Labeler Information

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

Labeler Name: J&j Company
Labeler Code: 74997
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: 05-08-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

W.skin Treemon Toner Product Label Images

W.skin Treemon Toner 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

Otc - Active Ingredient

Melaleuca Alternifolia (Tea Tree) Extract

Inactive Ingredient

Water, Butylene Glycol, Glycerin, Melaleuca Alternifolia (Tea Tree) Extract, Rosa Damascena Flower Water, Centella Asiatica Extract, Panthenol, Asiaticoside, Madecassoside, Fructan, Mentha Rotundifolia Leaf Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Melissa Officinalis Leaf Extract, Cymbopogon Schoenanthus Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Rosa Centifolia Flower Water, Portulaca Oleracea Extract, Scutellaria Baicalensis Root Extract , Paeonia Lactiflora Root Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Betaine, Sodium Hyaluronate, Xanthan Gum, Propanediol, 1,2-Hexanediol, Hydroxyacetophenone, Ethylhexylglycerin, Disodium EDTA

Otc - Purpose

This is made by carefully selecting ingredients such as tea tree extract, Centella Asiatica extract and Rosa Damascena flower water which helps to calm the skin.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Spread it out after washing and tap it remaining toner

Warnings

If there are any abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics. 2. Avoid using areas with wounds. 3. Precautions for storage and handling. 3.1) Keep out reach of children. 3.2) Keep it out of direct sunlight.

Dosage & Administration

For external use only

* Please review the disclaimer below.