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Mint - Medication Information

Product NDC Code 67510-0111
Drug Name

Mint

Type Brand
Active Ingredients
Sodium monofluorophosphate .76 g/100g
Route DENTAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 545626
Application Number part355
Labeler Name Kareway Product, Inc.
Packages
Package NDC Code Description
67510-0111-4 1 tube in 1 box (67510-0111-4) / 181 g in 1 tube
67510-0111-6 1 tube in 1 box (67510-0111-6) / 170 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% (0.15%w/v 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, preferably after each meal or at least twice a day, or as directed by a dentist or physician Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing). Children under 2 years ask a dentist or physician
Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).
Children under 2 years ask a dentist or physician

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients calcium carbonate, sorbitol, water, silicon dioxide, glycerine, sodium lauryl sulfate, sodium carboxymethyl cellulose, methyl parahydroxybenzoate, aminocaproic acid, xylitol, sodium saccharin, DL-menthol, flavor

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.
Usage 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.
Mint Sodium Monofluorophosphate CALCIUM CARBONATE SORBITOL WATER SILICON DIOXIDE GLYCERIN SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM METHYLPARABEN AMINOCAPROIC ACID XYLITOL SACCHARIN SODIUM MENTHOL SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION

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.
Enter section text here image of toothpaste carton

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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

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