NDC 61037-414 Chlorhexidine Gluconate Solution 0.75% Antiseptic

Chlorhexidine Gluconate Solution 0.75% Antiseptic

NDC Product Code 61037-414

NDC 61037-414-01

Package Description: 118 mL in 1 BOTTLE, PLASTIC

NDC 61037-414-02

Package Description: 236 mL in 1 BOTTLE, PLASTIC

NDC 61037-414-03

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC 61037-414-04

Package Description: 236 mL in 1 BOTTLE, PUMP

NDC 61037-414-05

Package Description: 473 mL in 1 BOTTLE, PLASTIC

NDC 61037-414-06

Package Description: 946 mL in 1 BOTTLE, PLASTIC

NDC 61037-414-07

Package Description: 3785 mL in 1 JUG

NDC 61037-414-08

Package Description: 1200 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Chlorhexidine Gluconate Solution 0.75% Antiseptic with NDC 61037-414 is a a human over the counter drug product labeled by Bajaj Medical, Llc. The generic name of Chlorhexidine Gluconate Solution 0.75% Antiseptic is chlorhexidine gluconate solution 0.75% antiseptic. The product's dosage form is solution and is administered via topical form.

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.

Chlorhexidine Gluconate Solution 0.75% Antiseptic 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.


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: Bajaj Medical, Llc
Labeler Code: 61037
FDA Application Number: NDA020111 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: 09-30-2014 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.

Chlorhexidine Gluconate Solution 0.75% Antiseptic Product Label Images

Chlorhexidine Gluconate Solution 0.75% Antiseptic 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 0.75% solution

Purposes

Antispetic

Uses

  • Healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warnings

For external use only.

Do Not Use

  • If you are allergic to chlorhexidine gluconate or any other ingredientsin contact with meningesin the genital areaas a preoperative skin preparation (especially on the head and face)on skin wondsgeneral skin cleanser as surgical hand scrub

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 water

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.

Other Safety Information

This product contains a chemical known to the State of California to cause Cancer.

Directions

  • Use with care in premature infants and infants under 2 months of age. These products may cause irritation or chemical burns.Healthcare personnel handwash:wet hands with waterdispense about 5 ml of product into cupped hands and wash in a vigorous manner for 30 secondsrinse and dry thoroughly

Other Information

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

Inactive Ingredients

Cocamide DEA, FD&C yellow #5, FD&C red #4, fragrance, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water, ricinoleamidopropyl trimethyl ammonium chloride

* Please review the disclaimer below.