NDC 78424-020 Jnn-ii Clean Tok Hand Gel

Alcohol

NDC Product Code 78424-020

NDC 78424-020-01

Package Description: 20 mL in 1 POUCH

NDC Product Information

Jnn-ii Clean Tok Hand Gel with NDC 78424-020 is a a human over the counter drug product labeled by Joy Life Co., Ltd.. The generic name of Jnn-ii Clean Tok Hand Gel is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Joy Life 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.

Jnn-ii Clean Tok Hand Gel 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 14 mL/20mL

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.

  • NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
  • BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
  • WATER (UNII: 059QF0KO0R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PLATYCLADUS ORIENTALIS LEAF (UNII: 32E5V7G32B)
  • PINUS DENSIFLORA LEAF (UNII: Q1Q9P50WIY)
  • OATMEAL (UNII: 8PI54V663Y)

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: Joy Life Co., Ltd.
Labeler Code: 78424
FDA Application Number: part333A 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: 09-23-2020 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.

Jnn-ii Clean Tok Hand Gel Product Label Images

Jnn-ii Clean Tok Hand Gel 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 70% w/w

Purpose

Antiseptic

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do Not Use

■ in children less than 2 months of age ■ on open skin wounds

When Using This Product

Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rash occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Take an appropriate amount on your hands, and then spread evenly. Rub hands together until dry.■ Supervise children under 6 years of age when using this product to avoid swallowing.■ Avoid direct inhalation of vapors during application. (Headaches and irritation to mucous membranes may occur when directly inhaled.)■ This product is intended only for hand sanitizing.

Other Information

■ Store between 15-30 °C (59-86 °F)■ Avoid freezing and excessive heat above 40 °C (104 °F)

Inactive Ingredients

Water, Butylene Glycol, Carbomer, Triethanolamine, Fragrance, Chamaecyparis Obtusa Leaf Extract, Biota Orientalis Leaf Extract, Nelumbo Nucifera Leaf Extract, Pinus Densiflora Leaf Extract, Bambusa Vulgaris Extract, Avena Sativa (Oat) Meal Extract, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, 1,2-Hexanediol, Maltodextrin

* Please review the disclaimer below.