NDC 0116-0061 Cardinal Health

NDC Product Code 0116-0061

NDC 0116-0061-04

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 0116-0061-08

Package Description: 237 mL in 1 BOTTLE, PLASTIC

This product is EXCLUDED from the official NDC directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions.

NDC Product Information

Cardinal Health with NDC 0116-0061 is a product labeled by Xttrium Laboratories, Inc.. The generic name of Cardinal Health is . The product's dosage form is and is administered via form.

Labeler Name: Xttrium Laboratories, Inc.

Dosage Form: -

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.

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.

  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • PEG-75 LANOLIN (UNII: 09179OX7TB)
  • TRIDECYL ALCOHOL (UNII: 8I9428H868)
  • COCO DIETHANOLAMIDE (UNII: 92005F972D)
  • HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • 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: Xttrium Laboratories, Inc.
Labeler Code: 0116
Start Marketing Date: 07-24-2015 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: Y 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.

Cardinal Health 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

Otc - 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: for the preparation of the patient's skin prior to surgery
  • Skin wound and general cleansing

Warnings

  • For external use onlyAllergy alert:​This product may cause a severe allergic reation. 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 meningesin the genital areaas a preoperative skin preparation of the head or face

When Using This Product

  • Keep out of 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 waterwound 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.

Direction

  • 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 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 separate nail cleaner may be usedrinse throughlywash for an additional 3 minutes with 5 mL of product and rinse under running water dry thoroughlyHealthcare personnel handwash:wet hands with waterdispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 secondsrinse and dry thoroughlyPatient preoperative skin preparation:apply product liberally to surgical site and swab for at least 2 minutes and dry with a sterile towelrepeat procecedure for an additional 2 minutes and dry with a sterile towelSkin wound and general 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, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.
WARNING: This product can expose you to chemicals including cocamide DEA, which is known to the State of California to cause cancer. For more informationm, go to P65Warnings.ca.gov
For Professional and Hospital Use Only You may report serious side effects to 1-877-227-3642Not Made with Natural Rubber Latex Distributed byCardinal Health Waukegan, IL 60085 USARev. D 2019-07 • cardinalhealth.com ©2019 Cardinal Health. All Rights Reserved.CARDINAL HEALTH and the Cardinal Health LOGO are trademarks of Cardinal Health and may be registered in the US and/or in other countries.

Package Label

NDC: 63517-061-04AS-4CHGL4Cardinal Health Chlorhexidine Gluconate 4% Solution Single-Use Antiseptic Non Sterile Solution 4 fl oz (118mL)NDC: 63517-061-08AS-4CHGL8 Cardinal Health Chlorhexidine Gluconate 4% Solution Antiseptic 8 fl oz (237 mL)

* Please review the disclaimer below.