NDC 73549-003 Hand Cleanser

Hand Cleanser

NDC Product Code 73549-003

NDC 73549-003-01

Package Description: 8 mL in 1 BOTTLE

NDC 73549-003-02

Package Description: 15 mL in 1 BOTTLE

NDC 73549-003-03

Package Description: 30 mL in 1 BOTTLE

NDC 73549-003-04

Package Description: 60 mL in 1 BOTTLE

NDC 73549-003-05

Package Description: 100 mL in 1 BOTTLE

NDC 73549-003-06

Package Description: 120 mL in 1 BOTTLE

NDC 73549-003-07

Package Description: 150 mL in 1 BOTTLE

NDC 73549-003-08

Package Description: 236 mL in 1 BOTTLE

NDC 73549-003-09

Package Description: 250 mL in 1 BOTTLE

NDC 73549-003-10

Package Description: 300 mL in 1 BOTTLE

NDC 73549-003-11

Package Description: 330 mL in 1 BOTTLE

NDC 73549-003-12

Package Description: 470 mL in 1 BOTTLE

NDC 73549-003-13

Package Description: 500 mL in 1 BOTTLE

NDC 73549-003-14

Package Description: 750 mL in 1 BOTTLE

NDC 73549-003-15

Package Description: 950 mL in 1 BOTTLE

NDC 73549-003-16

Package Description: 5000 mL in 1 BOTTLE

NDC Product Information

Hand Cleanser with NDC 73549-003 is a a human over the counter drug product labeled by Fortress Expert Co., Ltd. The generic name of Hand Cleanser is hand cleanser. The product's dosage form is gel and is administered via topical form.

Labeler Name: Fortress Expert Co., 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.

Hand Cleanser 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 76 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.

  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • HYDROGEN PEROXIDE (UNII: BBX060AN9V)

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: Fortress Expert Co., Ltd
Labeler Code: 73549
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: 05-03-2020 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.

Hand Cleanser Product Label Images

Hand Cleanser 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 75.05%

​Purpose

Antiseptic

Uses

Helps reduce bacteria that potentially can cause diseaseHelps prevent cross contamination by hand contactRecommended for repeated use

Warnings

For external use onlyFlammable, keep away from fire, heat,or flameDo not use near eyesIn case of eye contact flush with water for 15 minutesif irritation persists stop use of product and get medical attentionKeep out of reach of children.In case of accidental ingestion seek medical attention or contact a poison control center immediately.

Directions

Wet hands thoroughly with product and and rub completely covering handsAllow to dry without wipingChildren under the age of 6 should use with adultsupervisionNot recommended for infants

Inactive Ingredients

Walen , Glycerin, Carbomer, Hydrogen peroxideAminomethyl Propanol

* Please review the disclaimer below.