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| Product NDC Code | 69423-755 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Crest pro-health densify pro intensive repair |
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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.Drug Facts Active ingredient Stannous fluoride 0.454% (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 12 yrs. & older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist. Make sure to brush all sensitive areas of the teeth do not swallow children under 12 yrs. of age: ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients glycerin, sorbitol, water, hydrated silica, sodium lauryl sulfate, sodium citrate, flavor, sodium gluconate, carrageenan, xanthan gum, sodium saccharin, cocamidopropyl betaine, sodium hydroxide, stannous chloride, sucralose, titanium dioxide
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 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Purpose
Information about the drug product’s indications for use.Purposes Anticavity, antisensitivity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Crest Pro-Health Densify Pro Intensive Repair Stannous fluoride POLOXAMER 407 GLYCINE SODIUM HYDROXIDE SACCHARIN SODIUM TITANIUM DIOXIDE COCAMIDOPROPYL BETAINE SUCRALOSE STANNOUS CHLORIDE XANTHAN GUM SODIUM CITRATE WATER HYDRATED SILICA CARRAGEENAN SODIUM GLUCONATE GLYCERIN SORBITOL 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 in carton Crest PRO HEALTH FLUORIDE TOOTHPASTE FOR ANTICAVITY AND SENSITIVE TEETH DENSIFY ACTIVE REPAIR ACTIVELY REVERSES EARLY DECAY TO EXTEND THE LIFE OF TEETH* INTENSIVE CLEAN 3X DECAY PRO PREVENTION SYSTEM NET WT 0.85 OZ (24g) Artwork Densify
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.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. 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? 1-800-594-4158
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist.
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.When using this product do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. Keep out of reach of children. 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