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

NDC Product Code 0064-1080

NDC CODE: 0064-1080

Proprietary Name: Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
WHITE (C48325 - CLEAR)

NDC Code Structure

NDC 0064-1080-11

Package Description: 1150 mL in 1 BOTTLE, DISPENSING

NDC 0064-1080-59

Package Description: 59 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Surgicept Waterless, Surgical Handscrub And Healthcare Personnel Handwash with NDC 0064-1080 is a product labeled by Healthpoint, Ltd. The product's dosage form is and is administered via form.

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)

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
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: 12-31-2021 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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.

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.