NDC 74003-020 Jasna Pearl Hand Sanitizer

Alcohol

NDC Product Code 74003-020

NDC 74003-020-01

Package Description: 100 mL in 1 CONTAINER

NDC Product Information

Jasna Pearl Hand Sanitizer with NDC 74003-020 is a a human over the counter drug product labeled by Ella Cosmetic Co., Ltd.. The generic name of Jasna Pearl Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Ella Cosmetic 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.

Jasna Pearl Hand Sanitizer 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • GLYCYRRHIZA URALENSIS ROOT (UNII: 42B5YD8F0K)

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: Ella Cosmetic Co., Ltd.
Labeler Code: 74003
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: 05-01-2020 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’.

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Jasna Pearl Hand Sanitizer Product Label Images

Jasna Pearl Hand Sanitizer 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%

Purpose

Purpose: SANITIZER

Warnings

Warnings:For external use only.1.Do not use the product on the following areas:Around the eyes and ears, in the mouth, large body parts and damaged skin(Irritation may occur)2.If you experience any of the following symptoms, discontinue use of the product immediately and consult a physician or pharmacist.1) Hypersensitivity symptoms, e.g. rash, erythema, itchiness, and edema2)Skin irritation symptoms3.Other precautions1) For external use only (do not swallow).2) Avoid contact with eyes. If contact occurs, wash with clean water and consult a doctor or pharmacist.3)Be careful not to inhale vapors in cases of extended or prolonged use. (Repeating inhaling of large amounts of ethanol vapor may cause irritation of the mucous membranes and headaches).(Limited to ethanol-containing products)4) If used repeatedly in the same area, care should be provided as the skin may become rough due to excessive oil removal.5) Do not use sealed bandages, cast bandages, or packs as they may cause irritation.6) Do not use this drug on the anal or vagina areas, or with hot packs, as it may cause irritation or chemical burns.7) Use only for the intended purposes.4.Precautions for storage1) Keep away from direct sunlight and do not expose the product to heating devices or flame.2) Keep out of reach of children and go to the hospital immediately if swallowed.3) After use, close the lid completely to prevent the product from drying or foreign objects from getting inside the container.4) Storing the product in a different container may cause accidents or deterioration of quality. Therefore, keep the product in its original container.Dust or foreign substances may get on the product while using it.

Keep Out Of Reach Of Children

Keep out of reach of children and go to the hospital immediately if swallowed.

Uses

Uses: Disinfection of hands and skin

Directions

Directions:Take an appropriate amount on your hands and rub thoroughly to dry.

Inactive Ingredient

Inactive ingredients:WATER, GLYCERIN, CARBOMER, TRIETHANOLAMINE, BUTYLENE GLYCOL, CAMELLIA SINENSIS LEAF EXTRACT,GLYCYRRHIZA URALENSIS(LICORICE) ROOT EXTRACT

* Please review the disclaimer below.