NDC 0064-1080 Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash

Ethyl Alcohol

NDC Product Code 0064-1080

NDC 0064-1080-11

Package Description: 1150 mL in 1 BOTTLE, DISPENSING

NDC 0064-1080-59

Package Description: 59 mL in 1 BOTTLE

NDC Product Information

Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash with NDC 0064-1080 is a a human over the counter drug product labeled by Healthpoint, Ltd. The generic name of Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash is ethyl alcohol. The product's dosage form is solution and is administered via topical form.

Labeler Name: Healthpoint, 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.

Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash 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 .75 mL/mL

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.

  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)
  • WATER (UNII: 059QF0KO0R)

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: Healthpoint, Ltd
Labeler Code: 0064
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: 01-01-2006 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: 12-31-2020 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.

Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash Product Label Images

Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash 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 70% w/w

Purpose

Antiseptic

Uses

  • Surgical Hand Scrub:  Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.
  • Healthcare Personnel Handwash:  Handwash to help reduce bacteria that potentially can cause disease.  Recommended for repeated use.

Warnings

  • Flammable, keep away from fire or flame.For external use only.Do not useif you are allergic to or have a known or suspected hypersensitivity to any ingredient in this product.on or near the eyes, mucous membranes or mouth.  If product gets into the eyes, flush immediately with water.Stop use and ask a doctor if irritation, redness or allergic reaction occurs.
  • Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

Behentrimonium methosulfate, benzalkonium chloride, butylene glycol, cetyl alcohol, chlorhexidine gluconate, ethylhexylglycerin, isopropyl alcohol, phenoxyethanol, polyquaternium-10, PPG-3 myristyl ether, water.

Questions?

Please call


1-800-523-0502 (M-F 8 a.m.-5 p.m. CST) or visit our web site


www.surgicept.com.


PRINCIPAL DISPLAY PANELNDC 0064-1080-59Surgicept


®Ethyl alcohol 70% w/wWATERLESS Surgical Hand Scrub & Healthcare Personnel Handwash2 fl oz (59 ml)


129464-1010


Marketed by:


CareFusion, Leawood, KS 66211


Manufactured for:


Healthpoint, Ltd., Fort Worth, TX 76107


by DPT Laboratories, Ltd., San Antonio, TX 78215


REORDER NO. 0064-1080-59


PATENT NO. 6,846,846

* Please review the disclaimer below.