NDC 71080-0013 Cellskin Clean Pine

Alcohol

NDC Product Code 71080-0013

NDC 71080-0013-2

Package Description: 20 POUCH in 1 CARTON > 1.5 mL in 1 POUCH (71080-0013-1)

NDC Product Information

Cellskin Clean Pine with NDC 71080-0013 is a a human over the counter drug product labeled by Gtg Wellness Co., Ltd.. The generic name of Cellskin Clean Pine is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Gtg Wellness Co., Ltd.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Cellskin Clean Pine 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.

  • ALCOHOL 1.05 g/1.5mL

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.

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

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: Gtg Wellness Co., Ltd.
Labeler Code: 71080
FDA Application Number: part333E 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: 03-01-2020 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.

Cellskin Clean Pine Product Label Images

Cellskin Clean Pine 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

Active ingredients: ALCOHOL 70.00%

Inactive Ingredient

Inactive ingredients:Water, Glycerin, Butylene Glycol, 1,2-Hexanediol, Carbomer, Centella Asiatica Extract, Chamaecyparis Obtusa Leaf Extract, Citrus Limon (Lemon) Fruit Extract, Triethanolamine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Cymbopogon Nardus (Citronella) Oil, PEG-60 Hydrogenated Castor Oil, Triethanolamine

Purpose

Purpose: SANITIZER

Warnings

Warnings:1. In case of using cosmetics or after use, please consult a specialist if there is any abnormal symptom or side effect such as red spot, swelling or itching in direct sunlight.2. Do not use on wounded areas.3. Precautions for storage and handlinga) Keep out of reach of children.b) Avoid direct sunlight.

Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN

Uses

Uses:Remove contaminants from the hands.

Directions

Directions:1. Open the disposable pouch and put the entire amount of hand cleaner on your hand.2. Rub gently the front, back of your hands, between your fingers, and under your nails for 15 seconds.

* Please review the disclaimer below.