NDC 0126-0034 Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

Sodium Fluoride

NDC Product Code 0126-0034

NDC CODE: 0126-0034

Proprietary Name: Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 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: Sodium Fluoride 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 to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 0126 - Colgate Oral Pharmaceuticals, Inc.
    • 0126-0034 - Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride

NDC 0126-0034-46

Package Description: 500 mL in 1 BOTTLE

NDC Product Information

Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride with NDC 0126-0034 is a a human over the counter drug product labeled by Colgate Oral Pharmaceuticals, Inc.. The generic name of Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride is sodium fluoride. The product's dosage form is rinse and is administered via dental form.

Labeler Name: Colgate Oral Pharmaceuticals, Inc.

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

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 Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 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.

  • SODIUM FLUORIDE 2 mg/10mL

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)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHOSPHORIC ACID (UNII: E4GA8884NN)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • FD&C RED NO. 40 (UNII: WZB9127XOA)

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: 02-15-2011 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’.

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Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

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Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride Product Label Images

Colgate Phos-flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride 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 COMPANYNew York, NY 10022

Active Ingredient

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities

Otc - Keep Out Of Reach Of Children

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

Directions

  • Adults and children 6 years of age and olderuse once a day after brushing your teeth with a toothpastevigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit outdo not swallow the rinsedo not eat or drink for 30 minutes after rinsinginstruct children under 12 years of age in good rinsing habits (to minimize swallowing)supervise children as necessary until capable of using without supervisionchildren under 6 years of ageask a dentist or physician

Inactive Ingredients

Water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

1-800-468-6502

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