NDC 52305-001 Ethyl Alcohol

Alcohol

NDC Product Code 52305-001

NDC 52305-001-01

Package Description: 60 mL in 1 BOTTLE, PUMP

NDC 52305-001-02

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC 52305-001-03

Package Description: 296 mL in 1 BOTTLE, PUMP

NDC 52305-001-04

Package Description: 500 mL in 1 BOTTLE, PUMP

NDC 52305-001-30

Package Description: 300 mL in 1 BOTTLE, PUMP

NDC Product Information

Ethyl Alcohol with NDC 52305-001 is a a human over the counter drug product labeled by Freshorize Ltd. The generic name of Ethyl Alcohol is alcohol. The product's dosage form is gel and is administered via topical form.

Labeler Name: Freshorize 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.

Ethyl Alcohol 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
  • 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.

  • CARBOMER 934 (UNII: Z135WT9208)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • 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: Freshorize Ltd
Labeler Code: 52305
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: 06-15-2020 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Ethyl Alcohol Product Label Images

Ethyl Alcohol 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

Inactive Ingredients

Water (Aqua), Glycerin, Carbomer, Triethanolamine, Propylene Glycol, Tocopheryl, Aloe Barbadensis Leaf Juice.

Directions

Wet hands thoroughly with productBriskly rub hands together until drysupervise children under 6 years in the use of this product

Warnings

For external use only. Flammable, keep away from fire and flame. Do not use in the eyes. In case of contact, rinse eyes throughly with water.

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

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

Active Ingredient

Ethyl Alcohol 70% v/v

Other Information

Store at 20ºC to 25ºC (68º to 77ºF)May discolour certain fabrics

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.Recommended for repeated use.

Dosage & Administration

There are no specific directions. It is a hand sanitizer with the directions for use to just add to your hand and briskly rub until dry.

Typical use would be one pump.

Package Label

Alcohol Hand Sanitizer

* Please review the disclaimer below.