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Charm-tex fluoride - Medication Information

Product NDC Code 77573-011
Drug Name

Charm-tex fluoride

Type Brand
Active Ingredients
Sodium monofluorophosphate .1 g/100g
Route TOPICAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 545626
Application Number M021
Labeler Name Jiangsu Aimeili Cosmetic Co.,Ltd.
Packages
Package NDC Code Description
77573-011-01 720 tube in 1 package (77573-011-01) / 17 g in 1 tube
77573-011-02 720 tube in 1 package (77573-011-02) / 24 g in 1 tube
77573-011-03 144 tube in 1 package (77573-011-03) / 43 g in 1 tube
77573-011-04 144 tube in 1 package (77573-011-04) / 78 g in 1 tube
77573-011-05 60 tube in 1 package (77573-011-05) / 130 g in 1 tube
77573-011-06 60 tube in 1 package (77573-011-06) / 181 g in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Sodium Monofluorophosphate 0.76%(0.1 w/v Fluoride ion) Purpose Anticavity

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 6 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 a physician. Children 2 to 6 years: Use only a pea sized amount and supervise children'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 INGREDIENT Sorbitol, Silica, Calcium Carbonate, Methylparaben Sodium, Propylparaben Sodium, Flavor, Sodium Saccharin, Water, SCMC, Sodium Lauryl Sulfate

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.
Uses Help 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.
Charm-Tex FLUORIDE SODIUM MONOFLUOROPHOSPHATE SACCHARIN SODIUM SORBITOL GLYCERIN HYDRATED SILICA SODIUM LAURYL SULFATE CALCIUM CARBONATE WATER METHYLPARABEN SODIUM PROPYLPARABEN SODIUM 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.
image description

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.

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 Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately. Keep out of reach of children.

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