NDC 35000-882 Colgate Zero Fresh Breath

Cetylpyridinium Chloride

NDC Product Code 35000-882

NDC 35000-882-56

Package Description: 515 mL in 1 BOTTLE

NDC Product Information

Colgate Zero Fresh Breath with NDC 35000-882 is a a human over the counter drug product labeled by Colgate-palmolive Company. The generic name of Colgate Zero Fresh Breath is cetylpyridinium chloride. The product's dosage form is mouthwash and is administered via dental form.

Labeler Name: Colgate-palmolive Company

Dosage Form: Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.

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.

Colgate Zero Fresh Breath 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.

  • CETYLPYRIDINIUM CHLORIDE 15 mg/20mL

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SORBITOL (UNII: 506T60A25R)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • ZINC LACTATE (UNII: 2GXR25858Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)
  • REBAUDIOSIDE A (UNII: B3FUD0528F)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Colgate-palmolive Company
Labeler Code: 35000
FDA Application Number: part356 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: 12-12-2019 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.

Colgate Zero Fresh Breath Product Label Images

Colgate Zero Fresh Breath 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

Other

Drug Facts

Dist. by:COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A.

Active Ingredient

Cetylpyridinium Chloride 0.075%

Purpose

Antigingivitis/Antiplaque

Uses

  • Helps prevent and reduce plaque and gingivitishelps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums

Stop Use And Ask A Dentist If

  • Gingivitis, bleeding, or redness persists for more than 2 weeksyou have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children under 6 years of age.If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years of age and oldervigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.children 6 years to under 12 years of agesupervise usechildren under 6 years of agedo not use

Other Information

  • This rinse is not intended to replace brushing or flossingstore at 59°F to 77°Fkeep from freezing

Inactive Ingredients

Water, Glycerin, Propylene Glycol, Sorbitol, Poloxamer 407, Zinc Lactate, Flavor, Potassium Sorbate, Lactic Acid, Rebaudioside A.

Questions?

1-800-468-6502

* Please review the disclaimer below.