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Product NDC Code | 37000-489 | ||||
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Drug Name | Crest gum detoxify plus whitening |
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Type | Brand | ||||
Dosage Form | KIT | ||||
RxCUI drug identifier | 416784 | ||||
Application Number | M021 | ||||
Labeler Name | The Procter & Gamble Manufacturing Company | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.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. 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. 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, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, 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.Crest Gum Detoxify plus Whitening Stannous Fluoride Crest Gum Detoxifying Treatment Stannous Fluoride HYDRATED SILICA WATER ZINC LACTATE SODIUM LAURYL SULFATE SODIUM GLUCONATE GLYCERIN SACCHARIN SODIUM XANTHAN GUM CARBOXYMETHYLCELLULOSE SODIUM SODIUM HYDROXIDE MICA TITANIUM DIOXIDE FD&C BLUE NO. 1 SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS STANNOUS FLUORIDE FLUORIDE ION Crest Whitening Gel WATER GLYCERIN HYDROGEN PEROXIDE SODIUM ACID PYROPHOSPHATE SUCRALOSE SODIUM HYDROXIDE CARBOXYPOLYMETHYLENE
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 - Kit Carton CLINICALLY PROVEN RESULTS IN ONE WEEK Crest ® GUM DETOXIFY + WHITENING™ FLUORIDE TOOTHPASTE FOR ANTICAVITY AND ANTIGINGIVITIS/WHITENING GEL STEP 1 6X Gum health Improvement in one week* *gingivitis improvement vs. ordinary toothpaste STEP 2 Whiter teeth in 1 week** **improvement vs. ordinary toothpaste 1 TUBE NET WT 4.0 OZ (113 g) & 1 TUBE NET WT 2.3 OZ (65 g) 489
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
Dist. 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? (800) 492-7378
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 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.Warning 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. Directions adults and children 12 yrs. 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. do not swallow children under 12 yrs. of age: ask a dentist 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 see your dentist regularly Inactive ingredients glycerin, hydrated silica, water, zinc lactate, sodium lauryl sulfate, trisodium phosphate, flavor, sodium gluconate, sodium saccharin, xanthan gum, cellulose gum, sodium hydroxide, polyethylene, mica, titanium dioxide, blue 1
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