NDC 47593-408 Endure 320 Advanced Care

Ethyl Alcohol

NDC Product Code 47593-408

NDC 47593-408-32

Package Description: 1000 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Endure 320 Advanced Care with NDC 47593-408 is a a human over the counter drug product labeled by Ecolab Inc.. The generic name of Endure 320 Advanced Care is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Ecolab Inc.

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

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.

Endure 320 Advanced Care 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 62 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)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • EDETOL (UNII: Q4R969U9FR)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • 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.

Product Labeler Information

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

Labeler Name: Ecolab Inc.
Labeler Code: 47593
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: 01-28-2021 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: 12-31-2022 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.

Endure 320 Advanced Care Product Label Images

Endure 320 Advanced Care 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, 62% v/v

Purpose

Antiseptic handwash

Uses

Antiseptic handwash

Warnings

For external use onlyFLAMMABLE

When Using This Product

  • Avoid contact with eyes and mucous  membranesif in eyes, rinse promptly and thoroughly with water

Stop Use And Ask A Physician If

  • Skin irritation or redness occurs and persists 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 immediately.

Directions

  • Apply product onto hands, spread thoroughly and rub until dry.

Other Information

  • Keep away from fire or flameDo not store above 120oF (50oC)For emergency medical information in USA and Canada, call 1-800-328-0026For emergency medical information worldwide, call 1-651-222-5352 (IN USA)

Inactive Ingredient

Inactive ingredients  water, cetyl alcohol, PEG-32, glycerine, cyclomethicone, limnanthes alba (meadowfoam) seed oil, panthenol, acrylates/C10-30 alkyl acrylate crosspolymer, tetrahydroxypropyl ethylenediamine, isopropyl palmitate, dimethicone, tocopheryl acetate, titanium dioxide, fragrance, aloe barbadensis leaf juice.

Otc - Questions

Questions?  Call 1-866-781-8787.

* Please review the disclaimer below.