NDC 0116-0200 Betasept

Antiseptic Surgical Scrub

NDC Product Code 0116-0200

NDC 0116-0200-01

Package Description: 3785 mL in 1 BOTTLE

NDC 0116-0200-04

Package Description: 118 mL in 1 BOTTLE

NDC 0116-0200-08

Package Description: 237 mL in 1 BOTTLE

NDC 0116-0200-16

Package Description: 473 mL in 1 BOTTLE

NDC 0116-0200-30

Package Description: 946 mL in 1 BOTTLE

NDC 0116-0200-32

Package Description: 946 mL in 1 BOTTLE

NDC Product Information

Betasept with NDC 0116-0200 is a a human prescription drug product labeled by Xttrium Laboratories, Inc.. The generic name of Betasept is antiseptic surgical scrub. The product's dosage form is solution and is administered via topical form.

Labeler Name: Xttrium Laboratories, Inc.

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 Prescription 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.

Betasept 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.

  • CHLORHEXIDINE GLUCONATE .04 mg/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.

  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • WATER (UNII: 059QF0KO0R)
  • TRIDECYL ALCOHOL (UNII: 8I9428H868)

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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Xttrium Laboratories, Inc.
Labeler Code: 0116
FDA Application Number: NDA019125 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: NDA - A product marketed under an approved New Drug Application. 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: 06-01-1993 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.

Betasept 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

Chlorhexidine gluconate 4% solution

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: helps reduce bacteria that potentially can cause disease
  • Patient preoperative skin preparation: preparation of the patient's skin prior to surgery
  • Skin wound and general skin cleansing

Warnings

  • Warnings For external use only Allergy alert: This product may cause a severe allergic reaction. Symptoms may include: wheezing/difficulty breathing shock facial swelling hives rash If an allergic reaction, stop use and seek medical help right away.

Do Not Use

  • If you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product in contact with meninges in the genital area as a preoperative skin preparation of the head or face

When Using This Product

  • Keep out of the eyes, ears, and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when instilled in the middle ear through perforated eardrums. if solution should contact these areas, rinse out promptly and thoroughly with waterwounds which involve more than the superficial layers of the skin should not be routinely treated repeated general skin cleansing of large body areas should not be done except when advised by a health care provider

Stop Use And Ask A Doctor If

Irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. Surgical hand scrubwet hands and forearms with water scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spacesa seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 mL of product and rinse under running water dry thoroughly Healthcare personnel handwashwet hands with water dispense about 5 mL of priduct into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleansing thoroughly rinse the area to be cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly

Other Information

Store at 20-25°C (68-77°F) avoid excessive heat above 40°C (104°F)

Inactive Ingredients

Cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Other Safety Information

WARNING: Cancer - www.P65Warnings.ca.gov

* Please review the disclaimer below.