NDC 80736-002 Shield-ex Hand Sanitizer

Alcohol

NDC Product Code 80736-002

NDC 80736-002-01

Package Description: 80 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-02

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-03

Package Description: 250 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-04

Package Description: 500 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-05

Package Description: 900 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-06

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC 80736-002-07

Package Description: 5000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Shield-ex Hand Sanitizer with NDC 80736-002 is a a human over the counter drug product labeled by Amemed. The generic name of Shield-ex Hand Sanitizer is alcohol. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Amemed

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.

Shield-ex 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 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 HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

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: Amemed
Labeler Code: 80736
FDA Application Number: part333A 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: 10-02-2020 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.

Shield-ex Hand Sanitizer Product Label Images

Shield-ex 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

Ethanol Alchohol 70%

Use

To decrease bacteria on the skin that could cause disease. Recommended for repeated use.

Warnings

For External Use Only - hands.Ask a doctor if (a) irritation & redness develop or (b) condition persists for more than 72 hours.Caution: Keep out of reach of children. Avoid contact with mucus membrane, harmful if swallowed.Stop use and ask a doctor if skin irritation develops.

Directions

  • Wet hands thoroughly with product and rub hands together until dry. For children under 6, use only under adult supervision. Not recommended for infants.Other informationFlammable, do not store above 40 °C.May discolor some fabrics. May be harmful to wood finishes and plastic.

Inactive Ingredients

Purified Water, Carbomer, lsopropanol, lsopropyl Myiristate, Diisopropyl Sebacate, Propylene glycol, Aminomethyl Propanol, Fragrance Yellow 5, Blue 1.

* Please review the disclaimer below.