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| Product NDC Code | 35000-275 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Colgate total sf whitening |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||||
| Dosage Form | GEL, DENTIFRICE | ||||||||||
| RxCUI drug identifier | 416784 | ||||||||||
| Application Number | M021 | ||||||||||
| Labeler Name | Colgate-Palmolive 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% (0.15% 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 years of age and older: apply at least a 1-inch strip of the product onto a soft bristled 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 years of age: consult a dentist.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Sorbitol, Water, Hydrated Silica, Glycerin, Sodium Lauryl Sulfate, Flavor, Tetrasodium Pyrophosphate, Cellulose Gum, Potassium Nitrate, Sodium Saccharin, Xanthan Gum, Cocamidopropyl Betaine, 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 harmful effects of plaque associated with gingivitis 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, Antigingivitis, Antisensitivity
Spl product data elements
Usually a list of ingredients in a drug product.Colgate Total SF Whitening Stannous Fluoride STANNOUS FLUORIDE FLUORIDE ION SORBITOL WATER HYDRATED SILICA GLYCERIN SODIUM PYROPHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED POTASSIUM NITRATE SACCHARIN SODIUM XANTHAN GUM COCAMIDOPROPYL BETAINE FD&C BLUE NO. 1
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 - 170 g Tube Carton Colgate ® Anticavity, Antigingivitis and Antisensitivity Toothpaste Total ACTIVE PREVENTION Fight Root Cause † of: Gingivitis ✔ Plaque ✔ Tartar ✔ Cavities ✔ Sensitivity ✔ Bad Breath ✔ Enamel Erosion ✔ Stains ✔ WHITENING GEL CLINICALLY PROVEN ANTIBACTERIAL 24 HOUR 1 ADA Accepted American Dental Association ® NET WT 6.0 OZ (170 g) PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
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: COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A.
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? 1-800-468-6502
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 by a dentist.
Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
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 for sensitivity, do not use longer than 4 weeks unless recommended by a dentist.
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 Colgate product is specially formulated to help prevent staining.
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 When using this product for sensitivity, do not use longer than 4 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 by a dentist. 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. Stop use and ask a dentist if gingivitis, bleeding, or redness persists for more than 2 weeks you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs of periodontitis, a serious form of gum disease.
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