NDC 58503-120 Modesa Hand Sanitizer 2 Fl.oz. 3 Pk

Ethyl Alcohol 70.0% V/v

NDC Product Code 58503-120

NDC Code: 58503-120

Proprietary Name: Modesa Hand Sanitizer 2 Fl.oz. 3 Pk 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 70.0% V/v 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 Technology Co., Ltd.

NDC 58503-120-01

Package Description: 3 BOTTLE in 1 BOX > 59.2 mL in 1 BOTTLE (58503-120-00)

NDC Product Information

Modesa Hand Sanitizer 2 Fl.oz. 3 Pk with NDC 58503-120 is a a human over the counter drug product labeled by China Ningbo Shangge Technology Co., Ltd.. The generic name of Modesa Hand Sanitizer 2 Fl.oz. 3 Pk is ethyl alcohol 70.0% v/v. The product's dosage form is liquid and is administered via topical form.

Labeler Name: China Ningbo Shangge Technology Co., Ltd.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Modesa Hand Sanitizer 2 Fl.oz. 3 Pk 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.

  • WATER (UNII: 059QF0KO0R)
  • CARBOMER 934 (UNII: Z135WT9208)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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.

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 Technology Co., Ltd.
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: 06-27-2019 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: 12-31-2020 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.

Modesa Hand Sanitizer 2 Fl.oz. 3 Pk Product Label Images

Modesa Hand Sanitizer 2 Fl.oz. 3 Pk 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 ingredientEthyl Alcohol 70.0% v/v

Otc - Purpose

PurposeAntimicrobial

Indications & Usage

  • UsesFor handwashing to decrease bacteria on the skin Recommended for repeated use

Warnings

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

Otc - Ask Doctor

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

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.

Dosage & Administration

  • DirectionsWet hands thoroughly with productBriskly rub hands together until drySupervise children under 6 years in the use of this prodyuct

Other Safety Information

  • Other informationStore at room temperatureMay discolor certain fabrics

Inactive Ingredient

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

* Please review the disclaimer below.