NDC 74934-001 Color Element Hand Sanitizer With Moisturizers And Vitamin E

Alcohol Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
74934-001
Proprietary Name:
Color Element Hand Sanitizer With Moisturizers And Vitamin E
Non-Proprietary Name: [1]
Alcohol
Substance Name: [2]
Alcohol
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Zhejiang Icolor Biotech Co., Ltd
    Labeler Code:
    74934
    FDA Application Number: [6]
    505G(a)(3)
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    04-14-2020
    End Marketing Date: [10]
    01-31-2026
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Packages

    NDC Code 74934-001-01

    Package Description: 1000 mL in 1 BOTTLE

    NDC Code 74934-001-02

    Package Description: 2 mL in 1 BAG

    NDC Code 74934-001-03

    Package Description: 1000000 mL in 1 TANK

    NDC Code 74934-001-10

    Package Description: 100 mL in 1 BOTTLE

    NDC Code 74934-001-23

    Package Description: 236 mL in 1 BOTTLE

    NDC Code 74934-001-30

    Package Description: 300 mL in 1 BOTTLE

    NDC Code 74934-001-50

    Package Description: 500 mL in 1 BOTTLE

    NDC Code 74934-001-60

    Package Description: 60 mL in 1 BOTTLE

    NDC Code 74934-001-61

    Package Description: 60 BAG in 1 BOX / 2 mL in 1 BAG

    Product Details

    What is NDC 74934-001?

    The NDC code 74934-001 is assigned by the FDA to the product Color Element Hand Sanitizer With Moisturizers And Vitamin E which is a human over the counter drug product labeled by Zhejiang Icolor Biotech Co., Ltd. The generic name of Color Element Hand Sanitizer With Moisturizers And Vitamin E is alcohol. The product's dosage form is gel and is administered via topical form. The product is distributed in 9 packages with assigned NDC codes 74934-001-01 1000 ml in 1 bottle , 74934-001-02 2 ml in 1 bag , 74934-001-03 1000000 ml in 1 tank , 74934-001-10 100 ml in 1 bottle , 74934-001-23 236 ml in 1 bottle , 74934-001-30 300 ml in 1 bottle , 74934-001-50 500 ml in 1 bottle , 74934-001-60 60 ml in 1 bottle , 74934-001-61 60 bag in 1 box / 2 ml in 1 bag. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Color Element Hand Sanitizer With Moisturizers And Vitamin E?

    Place enough to cover both hands in the palm, and rub hands together until dry.Children under 6 years of age should be supervised by adult when using this product.

    What are Color Element Hand Sanitizer With Moisturizers And Vitamin E Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Color Element Hand Sanitizer With Moisturizers And Vitamin E UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Color Element Hand Sanitizer With Moisturizers And Vitamin E Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Color Element Hand Sanitizer With Moisturizers And Vitamin E?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".