NDC 58503-122 Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial

Ethyl Alcohol

NDC Product Code 58503-122

NDC CODE: 58503-122

Proprietary Name: Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial 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: Ethyl 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

  • 58503 - China Ningbo Shangge Cosmetic Technology Corp.
    • 58503-122 - Assured Instant Hand Sanitizer Refill 11.2oz

NDC 58503-122-01

Package Description: 331 mL in 1 BOTTLE

NDC Product Information

Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial with NDC 58503-122 is a a human over the counter drug product labeled by China Ningbo Shangge Cosmetic Technology Corp.. The generic name of Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial is ethyl alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: China Ningbo Shangge Cosmetic Technology Corp.

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.

Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial 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.

  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: China Ningbo Shangge Cosmetic Technology Corp.
Labeler Code: 58503
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: 02-03-2020 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.

Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial Product Label Images

Assured Instant Hand Sanitizer Refill 11.2oz Antimicrobial 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

Active Ingredient PurposeEthyl Alcohol 70.0% v/v..................... Antimicrobial

Otc - Purpose

Antimicrobial

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

  • Usesfor handwashing to decrease bacteria on the skinrecommended for repeated use

Dosage & Administration

  • Directionswet hands thoroughly with productbriskly rub hands together until drysupervise children under 6 years in the use of this product

Warnings

WarningsFor external use only.Flammable, keep away from heat and flame.Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

Inactive Ingredient

Inactive Ingredientswater, carbomer, triethanolamine, glycerin, propylene glycol, fragrance, aloe barbadensis leaf juice, tocopheryl acetate

Otc - Stop Use

Stop use and ask a doctor if irritation and redness develop and persist for more than 72 hours.

Other Safety Information

  • Other Informationstore at 20C to 25C (68F to 77F)may discolor certain fabrics

* Please review the disclaimer below.