NDC 0126-0192 Gel-kam Mint
Stannous Fluoride Gel, Dentifrice Dental

Product Information

Product Code0126-0192
Proprietary Name 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.
Gel-kam Mint
Non-Proprietary Name 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.
Stannous Fluoride
Product Type 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.
Human Otc Drug
Dosage FormGel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
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.
Colgate Oral Pharmaceuticals, Inc.
Labeler Code0126
FDA Application Number 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.
part355
Marketing Category 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.
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
01-01-1990
Listing Expiration Date 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.
12-31-2022
Exclude Flag 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".
N
NDC Code Structure

Usage Information


Product Characteristics

Flavor(s)PEPPERMINT (C73408)

Product Packages

NDC 0126-0192-93

Package Description: 1 TUBE in 1 CARTON > 122 g in 1 TUBE

Product Details

Gel-kam Mint is a human over the counter drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Gel-kam Mint is stannous fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.


What are Gel-kam Mint Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.


NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:


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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)


* Please review the disclaimer below.

Gel-kam Mint Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Active Ingredient



Stannous fluoride 0.4% (w/w)


Purposes



Anticavity/Sensitivity Relief


Uses



  • helps protect against cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Otc - Do Not Use



Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.


Otc - Stop Use



Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.


Otc - Keep Out Of Reach Of Children



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


Directions



  • adults and children 12 years of age or older: use after regular brushing and flossing
  • shake excess water from your toothbrush and cover bristles with gel
  • brush thoroughly
  • keep on your teeth for one minute and then spit out
  • do not swallow
  • do not rinse, eat or drink for 30 minutes
  • use once a day for cavity protection
  • use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician
  • make sure all sensitive areas are covered by using a toothbrush or a cotton swab
  • supervise children until capable of using without supervision
  • children under 12 years of age: consult a dentist or physician

Other Information



  • this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use
  • this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • do not use if embossed seal on tube is broken or missing
  • to open tube, remove cap and pierce foil seal with point of cap
  • keep tightly closed when not in use
  • store at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients



flavor, glycerin, hydroxyethylcellulose


Questions Or Comments?



call toll free at 1-800-962-2345


Principal Display Panel - 122 G Tube Carton - Mint



NDC 0126-0192-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
MINT

NET WT 4.3 OZ (122 g)


Principal Display Panel - 122 G Tube Carton - Fruit And Berry



NDC 0126-0165-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
FRUIT & BERRY

NET WT 4.3 OZ (122 g)


* Please review the disclaimer below.