NDC 74002-5050 Belson Hand Sanitizer

Alcohol

NDC Product Code 74002-5050

NDC 74002-5050-1

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC Product Information

Belson Hand Sanitizer with NDC 74002-5050 is a a human over the counter drug product labeled by Dongbangcosmetics Co., Ltd.. The generic name of Belson Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Dongbangcosmetics 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.

Belson 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 350 g/500mL

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)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • EDETOL (UNII: Q4R969U9FR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • HEDERA HELIX LEAF (UNII: ZP9XFG71A7)
  • SALVIA OFFICINALIS ROOT (UNII: 236QY0A1BL)

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: Dongbangcosmetics Co., Ltd.
Labeler Code: 74002
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: 06-01-2020 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.

Belson Hand Sanitizer Product Label Images

Belson 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

ALCOHOL 70.0 w%

Inactive Ingredients

Water, Carbomer, Tetrahydroxypropyl Ethylenediamine, Tocopheryl Acetate, Lavandula Angustifolia (Lavender) Oil,Hedera Helix (Ivy) Stem Extract, Salvia Officinalis (Sage) Extract

Purpose

SANITIZER

Warnings

1. Do not use on the following body parts.Around the eyes and ears, in the oral cavity, a wide range of body parts and damaged skin (may have irritating effects)2. If the following symptoms appear, stop using them immediately and consult a doctor or pharmacist.1) Hypersensitivity symptoms such as rash, erythema, itching, and edema2) Skin irritation symptoms3. Other precautions1) For external use only (do not underwear).2) Be careful not to get into your eyes, and if so, rinse well with clean water and consult a doctor or pharmacist.3) Be careful not to inhale vapor when using it extensively or for a long time (if you drink ethanol vapor in large quantities or repeatedly, irritation to the mucous membrane, headache, etc. may occur). (Only for products containing ethanol)4) When repeated use on the same site, be careful as the skin may become rough due to degreasing.5) When used in sealed bandages, cast bandages, packs, etc., irritation symptoms may appear.6) Do not use this medicine for anal or vaginal poultry as it may cause irritation or chemical burns.7) Do not use for any purpose.4. Precautions for storage1) Avoid shading and keep it in shading.2) Keep it out of reach of children, and if a child swallows it, go to the hospital right away.3) After use, close the product completely with a lid to prevent the product from drying out or entering foreign objects.4) Taking it out of the original container and storing it in another container may cause accidents due to misuse or deterioration in quality, so store it in the original container.

Keep Out Of Reach Of Children

Keep it out of reach of children, and if a child swallows it, go to the hospital right away.

Uses

Uses:Disinfection of hands and skin

Directions

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

* Please review the disclaimer below.