NDC 76718-004 Alcohol Disinfectant

Alcohol

NDC Product Code 76718-004

NDC 76718-004-01

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Alcohol Disinfectant with NDC 76718-004 is a a human over the counter drug product labeled by Guangzhou Jukang Sanitary Products Co., Ltd.. The generic name of Alcohol Disinfectant is alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Guangzhou Jukang Sanitary Products Co., Ltd.

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.

Alcohol Disinfectant 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 85 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)
  • GLYCERIN (UNII: PDC6A3C0OX)

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: Guangzhou Jukang Sanitary Products Co., Ltd.
Labeler Code: 76718
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: 07-17-2020 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.

Alcohol Disinfectant Product Label Images

Alcohol Disinfectant 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 85%

Purpose

Antiseptic

Use

For hand-washing to decrease bacteria on the skin.

Otc - Keep Out Of Reach Of Children

Supervise children under 6 years of age when using this product to avoid swallowing. If swallowed get medical.

Warnings:

For external use onlyDanger! Highly flammable liquid. Safety recoommended: Keep away from heat,  hot surfaces, sparks, open flames and other ignition surfaces. No smoking.Do not use: in children less than 2 months of age, on open skin wounds.When using this product, Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with eaterStop use and ask a doctor if irritation and rash occurs.Avoid freezing and excessive heat above 40℃ (104℉)

Dosage & Administration

Rub a small amount into your hands until dry, No need to rinse off.

Inactive Ingredients

Glycerin, water

* Please review the disclaimer below.