NDC 74934-009 Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E

Alcohol

NDC Product Code 74934-009

NDC CODE: 74934-009

Proprietary Name: Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Alcohol 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.

NDC Code Structure

  • 74934 - Zhejiang Icolor Biotech Co., Ltd
    • 74934-009 - Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E

NDC 74934-009-01

Package Description: 3800 mL in 1 BOTTLE

NDC Product Information

Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E with NDC 74934-009 is a a human over the counter drug product labeled by Zhejiang Icolor Biotech Co., Ltd. The generic name of Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Zhejiang Icolor Biotech 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.

Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E 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 .75 mL/mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SQUALANE (UNII: GW89575KF9)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • INULIN (UNII: JOS53KRJ01)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • FRUCTOSE (UNII: 6YSS42VSEV)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)

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: Zhejiang Icolor Biotech Co., Ltd
Labeler Code: 74934
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: 05-28-2020 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.

Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E Product Label Images

Mosaic Advanced Hand Sanitizer With Moisturizers And Vitamin E 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

Ethyl Alcohol 75% v/v

Purpose

Antiseptic

Uses

  • A hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.Flammable. Keep away from fire or flames.

When Using This Product

Do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

Stop Use And Ask A Doctor

If irritation or rash appears on the skin.

Keep Out Of Reach Of Children.

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

Directions

  • 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 appling this product.

Other Information

  • Store below 110°F(43°C).May discolor certain fabrics or surfaces.

Inactive Ingredients

Water, Glycerin, Squalane, Panthenol, Inulin, Sodium Hyaluronate, Fructose, Tocopheryl Acetate, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

* Please review the disclaimer below.