NDC 17856-0210 Paroex

Chlorhexidine Gluconate

NDC Product Code 17856-0210

NDC CODE: 17856-0210

Proprietary Name: Paroex 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.

Product Characteristics

Flavor(s):
MINT (C73404 - MINT FLAVOR)

NDC Code Structure

NDC 17856-0210-1

Package Description: 5 mL in 1 CUP, UNIT-DOSE

NDC 17856-0210-2

Package Description: 10 mL in 1 CUP, UNIT-DOSE

NDC 17856-0210-3

Package Description: 15 mL in 1 CUP, UNIT-DOSE

NDC Product Information

Paroex with NDC 17856-0210 is a a human prescription drug product labeled by Atlantic Biologicals Corp.. The generic name of Paroex is chlorhexidine gluconate. The product's dosage form is rinse and is administered via oral form.

Labeler Name: Atlantic Biologicals Corp.

Dosage Form: Rinse - A liquid used to cleanse by flushing.

Product Type: Human Prescription 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.

Paroex 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 1.2 mg/mL

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Cell Wall Integrity - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: Atlantic Biologicals Corp.
Labeler Code: 17856
FDA Application Number: ANDA076434 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: ANDA - A product marketed under an approved Abbreviated 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: 10-31-2014 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: 12-31-2022 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".

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Paroex 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

To Open, Press Down While Turning The Cap. To Seal, Turn Until Cap Clicks And Is Tight.

Directions for Use: Fill dosage cup to the fill line (15 mL). Swish in your mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed by your dentist.Note: To minimize medicinal taste, do not rinse with water immediately after use.Rx Only.Keep Out Of Reach Of Children.

What To Expect When Using Paroex® (Chlorhexidine Gluconate Oral Rinse Usp, 0.12%):

  • Your dentist has prescribed Paroex® to treat your gingivitis - to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding.Use Paroex® regularly, as directed by your dentist, in addition to daily brushing and flossing. Spit out after use. Paroex® should not be swallowed.If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Paroex® should not be used by persons who have a sensitivity to it or its components.Paroex® may cause some tooth discoloration, or increases in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain and tartar at least every six months, or more frequently if your dentist advises.Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings.To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.Paroex® may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of Paroex®.To avoid taste interference, rinse with Paroex® after meals. Do not rinse with water or other mouthwashes immediately after rinsing with Paroex®.If you have any questions or comments about Paroex®, contact your dentist, pharmacist or Sunstar Americas, Inc. at 1-800-528-8537. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP controlled room temperature].Manufactured for: Sunstar Americas, Inc., Chicago, IL 60630

* Please review the disclaimer below.