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Mckesson fluoride - Medication Information

Product NDC Code 68599-0123
Drug Name

Mckesson fluoride

Type Brand
Active Ingredients
Sodium monofluorophosphate 2.43 mg/g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
Application Number M022
Labeler Name McKesson Medical-Surgical
Packages
Package NDC Code Description
68599-0123-1 144 box in 1 carton (68599-0123-1) / 1 tube in 1 box / 43 g in 1 tube
68599-0123-2 144 box in 1 carton (68599-0123-2) / 1 tube in 1 box / 78 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Sodium Monofluorophosphate 0.76% (0.122% w/v of fluoride ion)

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions Adults and children 2 years of age and older: Brush teeth thoroughly after meals or at least twice daily, or as directed by a dentist or physician. Children under 6 years of age: Use a pea-sized amount to minimize swallowing and supervise child's brushing until good habits are established. Children under 2 years of age: Ask a dentist or physician.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients calcium carbonate, purified water, sorbitol, hydrated silica, glycerin, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, carboxy methyl cellulose, sodium benzoate, sodium saccharin

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use Helps protect against cavities.

Purpose

Information about the drug product’s indications for use.
Purpose Anticavity

Spl product data elements

Usually a list of ingredients in a drug product.
McKesson Fluoride Sodium Monofluorophosphate CALCIUM CARBONATE WATER SORBITOL HYDRATED SILICA GLYCERIN SODIUM LAURYL SULFATE SODIUM PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM BENZOATE SACCHARIN SODIUM SACCHARIN SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION MINT

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel – 1.5 oz Case Label Mint Flavor M c KESSON Fluoride Toothpaste 1 Tube per Box, 1.5 oz 144 Boxes Per Case Reorder No. 16-9571 Principal Display Panel – 1.5 oz Case Label Principal Display Panel – 1.5 oz Box Label Mint Flavor M c KESSON Fluoride Toothpaste Net Wt. 1.5 oz. (43g) Principal Display Panel – 1.5 oz Box Label Principal Display Panel – 1.5 oz Tube Label Mint Flavor M c KESSON Fluoride Toothpaste Net Wt. 1.5 oz. (43g) Principal Display Panel – 1.5 oz Tube Label

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API