NDC 0126-0165 Gel-kam Fruit And Berry

Stannous Fluoride

NDC Product Code 0126-0165

NDC 0126-0165-93

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

NDC Product Information

Gel-kam Fruit And Berry with NDC 0126-0165 is a a human over the counter drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Gel-kam Fruit And Berry is stannous fluoride. The product's dosage form is gel, dentifrice and is administered via dental form.

Labeler Name: Colgate Oral Pharmaceuticals, Inc.

Dosage Form: Gel, 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.

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.

Gel-kam Fruit And Berry 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.

  • STANNOUS FLUORIDE 1 mg/g

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.

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

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.
  • 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 Oral Pharmaceuticals, Inc.
Labeler Code: 0126
FDA Application Number: part355 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-01-1990 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: 12-31-2020 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.

Gel-kam Fruit And Berry 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

Active Ingredient

Stannous fluoride 0.4% (w/w)

Purposes

Anticavity/Sensitivity Relief

Uses

  • Helps protect against cavitiesbuilds 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 flossingshake excess water from your toothbrush and cover bristles with gelbrush thoroughlykeep on your teeth for one minute and then spit outdo not swallowdo not rinse, eat or drink for 30 minutesuse once a day for cavity protectionuse twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physicianmake sure all sensitive areas are covered by using a toothbrush or a cotton swabsupervise children until capable of using without supervisionchildren 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 usethis 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 dentistdo not use if embossed seal on tube is broken or missingto open tube, remove cap and pierce foil seal with point of capkeep tightly closed when not in usestore at controlled room temperature 68-77°F (20-25°C)

Inactive Ingredients

Flavor, glycerin, hydroxyethylcellulose

* Please review the disclaimer below.