NDC 0116-0162 Antiseptic Skin Cleanser
Chlorhexidine Gluconate 4% Liquid Topical

Product Information

What is NDC 0116-0162?

The NDC code 0116-0162 is assigned by the FDA to the product Antiseptic Skin Cleanser which is a human over the counter drug product labeled by Xttrium Laboratories, Inc.. The generic name of Antiseptic Skin Cleanser is chlorhexidine gluconate 4%. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 0116-0162-08 237 ml in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0116-0162
Proprietary Name 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.		Antiseptic Skin Cleanser
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Chlorhexidine Gluconate 4%
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Chlorhexidine Gluconate
Product Type 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.		Human Otc Drug
Dosage FormLiquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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.		Xttrium Laboratories, Inc.
Labeler Code0116
FDA Application Number 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.		NDA019125
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		01-01-2014
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Antiseptic Skin Cleanser?


Product Packages

NDC Code 0116-0162-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

Product Details

What are Antiseptic Skin Cleanser Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Antiseptic Skin Cleanser Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
  • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub

Antiseptic Skin Cleanser Inactive Ingredients UNII Codes

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.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Antiseptic Skin Cleanser Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



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
  • skin wound and general skin cleansing

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 occurs, 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

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 of may cause deafness when instilled in the middle ear through perforated eatdrums.
  • if solution should contact these areas, rinse out promptly and thoroughly with water
  • wounds 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 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 scrub:

    • wet hands and forearms under running water
    • scrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spaces
    • a separate 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 handwash:

      • wet hands with water
      • dispense about 5 mL of product into cupped hands and wash in vigorous manner for about 15 seconds
      • rinse and dry thoroughly

        • Skin wound and normal 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.


Questions Or Comments?



call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST


Package Label And Principal Display Panel



NDC 41250-162-08

Compare to the active ingredient in Hibiclens®*

Reduces bacteria on the skin

Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4% Solution

Antiseptic/Antimicrobial Skin Cleanser

FOR EXTERNAL USE ONLY

Dye Free

8 FL OZ (237 mL)

TAMPER EVIDENT: DO NOT USE IF SHRINK SEAL NECKBAND IS BROKEN OR MISSING.

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* Please review the disclaimer below.