NDC 73565-011 Chlorhexidine Gluconate Applicator

Chlorhexidine Gluconate Applicator

NDC Product Code 73565-011

NDC CODE: 73565-011

Proprietary Name: Chlorhexidine Gluconate Applicator 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 Applicator 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 73565-011-10

Package Description: 10.5 g in 1 BOTTLE, DROPPER

NDC 73565-011-26

Package Description: 26 g in 1 BOTTLE, DROPPER

NDC Product Information

Chlorhexidine Gluconate Applicator with NDC 73565-011 is a a human over the counter drug product labeled by Miraclean Technology Co.,ltd. The generic name of Chlorhexidine Gluconate Applicator is chlorhexidine gluconate applicator. The product's dosage form is solution and is administered via topical form.

Labeler Name: Miraclean Technology Co.,ltd

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 Applicator 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.

  • ISOPROPYL ALCOHOL 70 g/100g
  • CHLORHEXIDINE GLUCONATE 2 g/100g

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.

  • 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.
  • 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: Miraclean Technology Co.,ltd
Labeler Code: 73565
FDA Application Number: part333A 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: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 02-17-2020 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 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.

Chlorhexidine Gluconate Applicator Product Label Images

Chlorhexidine Gluconate Applicator 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 Ingredients

Chlorhexidine gluconate,( 2% solution ) ,

Isopropyl alcohol,( 70% solution )

Ask A Doctor

If any irritation or allergic reaction occurs

Do Not Use

■ If any open wounds

■ If package damaged or expired

■ If the patient is allergic to chlorhexidine gluconate or any other ingredient in this product

Keep Out Of The Reach Of Children

Keep out of the reach of children

Purpose

Antiseptic

Stop Use And Ask A Doctor

If any irritation or allergic reaction occurs

Inactive Ingredient

■ Water

Other Information

■ Stored between 4-30℃

Avoid exclusive heat above 40℃ (104° F)

Directions

Peel apart the package and remove the applicator

Pull and remove the ring collar lock from the handle

Wet the treatment area with the fluid

Press down the handle to activate and release the solution flow into the sponge pad

Use

For skin preparation before surgery

Warnings

■ Single-use product

■ Keep away from flames or sparks

■ Keep out of the reach of children

* Please review the disclaimer below.