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Product NDC Code | 37000-989 | ||||||
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Drug Name | Crest 3d white brilliance charcoal |
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Type | Brand | ||||||
Active Ingredients |
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Route | DENTAL | ||||||
Dosage Form | PASTE, DENTIFRICE | ||||||
RxCUI drug identifier | 891775 | ||||||
Application Number | M021 | ||||||
Labeler Name | Procter & Gamble Manfuacturing Company | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Sodium fluoride 0.243% (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 yrs. & older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 yrs.: ask a dentist
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, hydrated silica, disodium pyrophosphate, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, sodium saccharin, carbomer, charcoal powder, sucralose, polysorbate 80, mica, 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.Use helps protect against cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity toothpaste
Spl product data elements
Usually a list of ingredients in a drug product.Crest 3D White Brilliance Charcoal Sodium Fluoride CARBOXYPOLYMETHYLENE SODIUM ACID PYROPHOSPHATE CARBOXYMETHYLCELLULOSE SODIUM ACTIVATED CHARCOAL POLYSORBATE 80 WATER SACCHARIN SODIUM HYDRATED SILICA SODIUM LAURYL SULFATE SUCRALOSE TITANIUM DIOXIDE SORBITOL SODIUM HYDROXIDE MICA SODIUM 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 - 110 g Carton ACTIVE STAIN PREVENTION* Crest ® 3D WHITE™ FLUORIDE ANTICAVITY TOOTHPASTE BRILLIANCE ADVANCED WHITENING UP TO 90% SURFACE STAIN REMOVAL CHARCOAL MINT NET WT 3.9 OZ (110 g) 989
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 6 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? 1-800-492-7378
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 6 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