NDC 71788-016 Foaming Chlorhexidine Gluconate

Chlorhexidine Gluconate

NDC Product Code 71788-016

NDC CODE: 71788-016

Proprietary Name: Foaming Chlorhexidine Gluconate 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 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 71788-016-20

Package Description: 4 BOTTLE, PUMP in 1 CARTON > 1000 mL in 1 BOTTLE, PUMP (71788-016-10)

NDC 71788-016-60

Package Description: 12 BOTTLE, PUMP in 1 CARTON > 530 mL in 1 BOTTLE, PUMP (71788-016-50)

NDC 71788-016-80

Package Description: 24 BOTTLE, PUMP in 1 CARTON > 100 mL in 1 BOTTLE, PUMP (71788-016-70)

NDC Product Information

Foaming Chlorhexidine Gluconate with NDC 71788-016 is a a human over the counter drug product labeled by Protect U Guard, Llc. The generic name of Foaming Chlorhexidine Gluconate is chlorhexidine gluconate. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Protect U Guard, Llc

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.

Foaming Chlorhexidine Gluconate 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 g/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.

  • WATER (UNII: 059QF0KO0R)
  • LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
  • ISOPROPYL ALCOHOL (UNII: ND2M416302)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Protect U Guard, Llc
Labeler Code: 71788
FDA Application Number: part349 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: 04-13-2021 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: 12-31-2022 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.

Foaming Chlorhexidine Gluconate Product Label Images

Foaming Chlorhexidine Gluconate 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% w/v

Purpose

Antiseptic

Uses

Antimicrobial skin cleanser helps reduce bacteriafor skin wound and skin cleansingsurgical hand scrubhealthcare personnel handwash

Warnings

For external use only.

Do Not Use

If you are allergic to chlorhexidine gluconate or any other ingredient(s) in this preparationas a patient preoperative skin preparation of the head or facein contact with the meninges or in the genital areaon wounds involving more than the superficial layers of skinas a general skin cleanser

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 contact occurs in any of these areas, rinse with cold water right awaydo not inhale or ingest

Keep Out Of Reach Of Children

If swallowed get medical help or contact a Poison Control Center right away.

Stop Use And Ask A Doctor If

Irritation, sensitization, or allergic reaction occurs and lasts 72 hours. These may be signs of a serious condition.

Directions

Use with care in premature infants under 2 months of age. These products may cause irritation or chemical burns.skin wound and skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughlysurgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with 5mL of the product with brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.healthcare personnel handwash. Wet hands with water. Dispense 5 mL of the product into cupped hands. Wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Other Information

May discolor some fabrics. Do not use with bleach.Store between 20-25° C ( 68-77° F). Avoid excessive heat.

Inactive Ingredients:

Water, lauramine oxide, isopropyl alcohol, gluconolactone.

* Please review the disclaimer below.