NDC 0116-8500 Provon Antimicrobial Foam Handwash

Chlorhexidine Gluconate 2%

NDC Product Code 0116-8500

NDC 0116-8500-89

Package Description: 1200 mL in 1 BOTTLE, DISPENSING

NDC 0116-8500-90

Package Description: 1250 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Provon Antimicrobial Foam Handwash with NDC 0116-8500 is a a human over the counter drug product labeled by Xttrium Laboratories, Inc.. The generic name of Provon Antimicrobial Foam Handwash is chlorhexidine gluconate 2%. 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 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.

Provon Antimicrobial Foam 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.

  • CHLORHEXIDINE GLUCONATE 20 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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • 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.

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: NDA019422 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: 07-01-2016 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 - NO 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.

Provon Antimicrobial Foam 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

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Uses

  • Healthcare personnel handwash: helps reduce bacteria that potentially can cause disease
  • Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care

Warnings

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

Do Not Use

  • If you are allergic to chlorhexidine gluconate or any other ingredient in this product

When Using This Product

  • Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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 water do not use routinely if you have wounds which involve more than the superficial layers of the skin

Otc - Stop Use

Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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.Healthcare personnel handwash:wet hands with water dispense 5 mL of product (6 full strokes) into cupped hands and wash in a vigorous manner for 15 seconds and rinse under running water and dry thoroughly Surgical hand scrub: wet hands and forearms with water scrub for 3 minutes with 5 mL of product (6 full stokes), with a wet brush, paying close attention to the nails, cuticles, and skin between the fingers a seperate nail cleaner may be used rinse thoroughly wash for an additional 3 minutes with 5 mL of product (6 full strokes) and rinse under running water and dry thoroughly

Other Information

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

Inactive Ingredients

Citric add. cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Recent Major Changes

Indications and Usage Dosage and Administration

* Please review the disclaimer below.