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| Product NDC Code | 69423-908 | ||||
|---|---|---|---|---|---|
| Drug Name | Gleem protection |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416784 | ||||
| Application Number | M021 | ||||
| Labeler Name | The Procter & Gamble Manufacturing Company | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous fluoride 0.454% (0.14% 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 12 yrs. of age & older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. do not swallow children under 12 yrs.: ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, hydrated silica, sodium lauryl sulfate, sodium gluconate, carrageenan, flavor, sodium citrate, xanthan gum, zinc citrate, sodium hydroxide, stannous chloride, sodium saccharin, sucralose, titanium dioxide, blue 1
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 aids in the prevention of cavities helps prevent gingivitis helps interfere with the harmful effects of plaque associated with gingivitis helps control plaque bacteria that contribute to the development of gingivitis
Purpose
Information about the drug product’s indications for use.Purposes Anticavity, antigingivitis toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.GLEEM Protection Stannous Fluoride STANNOUS CHLORIDE SUCRALOSE HYDRATED SILICA SORBITOL SODIUM CITRATE ZINC CITRATE WATER SODIUM LAURYL SULFATE SODIUM GLUCONATE CARRAGEENAN SACCHARIN SODIUM XANTHAN GUM TITANIUM DIOXIDE SODIUM HYDROXIDE FD&C BLUE NO. 1 STANNOUS FLUORIDE 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.PRINCIPAL DISPLAY PANEL - 99 g Tube Carton GLEEM FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS PROTECTION CAVITY PROTECTION NET WT 4.1 OZ (116 g) 69423908
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
DISTR. BY PROCTER & GAMBLE, CINCINNATI, OH 45202
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 12 yrs. of age . If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-855-510-8802
Storage and handling
Information about safe storage and handling of the drug product.Other information products containing stannous fluoride 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 dentist this product is specially formulated to help prevent staining see your dentist regularly
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 reach of children under 12 yrs. 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