NDC 0116-0161 Antiseptic Skin Cleanser

Chlorhexidine Gluconate 4%

NDC Product Code 0116-0161

NDC CODE: 0116-0161

Proprietary Name: Antiseptic Skin Cleanser 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.

Non-Proprietary Name: Chlorhexidine Gluconate 4% 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

NDC Code Structure

NDC 0116-0161-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

NDC 0116-0161-15

Package Description: 15 mL in 1 KIT

NDC 0116-0161-16

Package Description: 473 mL in 1 BOTTLE, PUMP

NDC Product Information

Antiseptic Skin Cleanser with NDC 0116-0161 is a 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.

Labeler Name: Xttrium Laboratories, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Antiseptic Skin Cleanser 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 4 mg/100mL

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.

  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • WATER (UNII: 059QF0KO0R)
  • TRIDECYL ALCOHOL (UNII: 8I9428H868)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)

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: 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: 05-01-2011 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.

Antiseptic Skin Cleanser 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
  • Skin wound and general skin cleansing

Warnings

  • For external use onlyAllergy alert:This product may cause a severe allergic reaction. Symptoms may include:wheezing/difficulty breathingfacial swellinghivesrashIf 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 productin contact with meningesin the genital area

When Using This Product

  • Keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if pemitted to ener and remain in the eye or may cause deafness when instilled in the middle eat 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 treatedrepeated 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 scrub:wet hands and forearms under running waterscrub for 3 minutes with about 5 mL of product and a wet brush, paying close attention to the nails, cuticles, and interdigital spacesa separate nail cleaner may be usedrinse thoroughlywash for an additional 3 minutes with 5 mL of product and rinse under running waterdry thoroughlyHealthcare personnel handwash:wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 secondsrinse and dry thoroughlySkin wound and normal skin cleansing:thoroughly rinse the area to be cleaned with waterapply the minimum amount of product necessary to cover the skin or wound area and wash gentlyrinse 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

Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine-releasing products. Rinse completely and use only non-chlorine detergents.






WARNING: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.






‡Walgreens Pharmacist Survey Study, November 2014‡‡This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.Distributed by: Walgreen Co.200 Wilmot RD., Deerfield, IL 60015100% Satisfaction Guaranteedwalgreens.com©2015 Walgreen Co.






Made in USA

Carton

NDC 0363-1061-15Walgreens, Co.Chlorhexidine Gluconate 4% SolutionAntiseptic Skin Cleansing KitDistributed by:Xttrium Laboratories, Inc.,Mount Prospect, IL 600564WAL15INNERCTNA0.5 FL OZ (15 mL)

Lidstock

NDC 0363-1061-15Walgreens, Co.Chlorhexidine Gluconate 4% SolutionAntiseptic Skin Cleansing KitDistributed by:Xttrium Laboratories, Inc.,Mount Prospect, IL 600564WAL15LIDSTOCKA0.5 FL OZ (15 mL)

Packet

NDC 0363-1061-15Walgreens, Co.Chlorhexidine Gluconate 4% SolutionAntiseptic Skin Cleansing Convenience KitDistributed by:Xttrium Laboratories, Inc.,Mount Prospect, IL 600564WAL15PACKETA

0.5 FL OZ (15 mL)

* Please review the disclaimer below.