NDC 77049-0003 Cosmerit Hand Sanitizer 1g

Alcohol

NDC Product Code 77049-0003

NDC 77049-0003-1

Package Description: 3785 mL in 1 CONTAINER

NDC Product Information

Cosmerit Hand Sanitizer 1g with NDC 77049-0003 is a a human over the counter drug product labeled by Interkos Co.,ltd.. The generic name of Cosmerit Hand Sanitizer 1g is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Interkos 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.

Cosmerit Hand Sanitizer 1g 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 70 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.

  • PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 934 (UNII: Z135WT9208)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Interkos Co.,ltd.
Labeler Code: 77049
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: 07-04-2020 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.

Cosmerit Hand Sanitizer 1g Product Label Images

Cosmerit Hand Sanitizer 1g 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

Alcohol

Inactive Ingredient

Water, Carbomer, Triethanolamine, PEG-60 Hydrogenated Castor Oil, Fragrance, Chlorphenesin, Trideceth-10, Butylene Glycol, Origanum Vulgare Leaf Extract, Chamaecyparis Obtusa Leaf Extract, Salix Alba (Willow) Bark Extract, Cinnamomum Cassia Bark Extract, Lactobacillus/Soybean Ferment Extract, Portulaca Oleracea Extract, Vincetoxicum Atratum Extract, Scutellaria Baicalensis Root Extract, 1,2-Hexanediol, Caprylyl Glycol, Aloe Barbadensis Leaf Extract, Illicium Verum (Anise) Fruit Extract

Otc - Purpose

■ instant healthcare personnel hand antiseptic to reduce bacteria that potentially can cause disease■ instant hand antiseptic to decrease bacteria on the skin

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF THE CHILDREN

Indications & Usage

Pump an appropriate amount on to the hands and rub together until dry

Warnings

1. Do not use this product on the following parts of body. Around eyes and ears, oral cavity, large area of the

parts of body, or wounded skins (It may cause irritations)

2. Stop using at once in case of the following symptoms, and seek medical advice. 1) When eczema, red spots,

itchiness, edema, and allergic reactions occur. 2)When skin irritations happen.

3. Other user reminders 1) For external use only(No oral intake). 2) Avoid contact with eyes, and in case contact

occurs, rinse it thoroughly with clean water and consult a doctor or pharmacist. 3) When you use it on a large skin

area or use it long-termly, please be aware that vapor is not absorbed. (If Ethanol vapor is largely and repeatedly

inhaled and absorbed, it may cause irritation to mucous membrane and headache might occur.) 4)When the product

is used on the same part of skin repeatedly, the skin may become rough due to skimming. 5) Do not use with sealed

gauze bandage, Gibbs bandage or pack, as irritations may occur. 6) Do not use this product while anus and vagina

steaming as irritations or chemical burns may occur. 7) Do not use for purposes other than specified.

Dosage & Administration

External use only

* Please review the disclaimer below.