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| Product NDC Code | 35000-998 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Colgate optic white stain fighter sens relief |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | DENTAL | ||||||
| Dosage Form | PASTE, DENTIFRICE | ||||||
| RxCUI drug identifier | 1038929 | ||||||
| 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 ingredients Purpose Potassium Nitrate 5% Antisenstivity Sodium Fluoride 0.24% (0.15% w/v fluoride ion) Anticavity
| Potassium Nitrate 5% | Antisenstivity |
| Sodium Fluoride 0.24% (0.15% w/v fluoride ion) | Anticavity |
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 bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth. children under 12 years consult a dentist or physician
| adults and children 12 years of age and 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 or physician. Make sure to brush all sensitive areas of the teeth. |
| children under 12 years | consult a dentist or physician |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Sorbitol, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Potassium Hydroxide, Tetrasodium Pyrophosphate, Phosphoric Acid, Cocamidopropyl Betaine, Sodium Saccharin, Benzyl Alcohol, 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 builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact helps protect against cavities
Purpose
Information about the drug product’s indications for use.Active ingredients Purpose Potassium Nitrate 5% Antisenstivity Sodium Fluoride 0.24% (0.15% w/v fluoride ion) Anticavity
| Potassium Nitrate 5% | Antisenstivity |
| Sodium Fluoride 0.24% (0.15% w/v fluoride ion) | Anticavity |
Spl product data elements
Usually a list of ingredients in a drug product.Colgate Optic White Stain Fighter Sens Relief SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION POTASSIUM NITRATE NITRATE ION WATER HYDRATED SILICA SORBITOL POLYETHYLENE GLYCOL 600 POTASSIUM PYROPHOSPHATE SODIUM LAURYL SULFATE CARBOXYMETHYLCELLULOSE COCAMIDOPROPYL BETAINE SACCHARIN SODIUM POTASSIUM HYDROXIDE TITANIUM DIOXIDE PHOSPHORIC ACID BENZYL ALCOHOL
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 - 119 g Tube Carton Colgate ® Anticavity Toothpaste for Sensitive Teeth OPTIC WHITE ® STAIN FIGHTER ® SENSITIVITY RELIEF REMOVES 5X MORE SURFACE STAINS* WITH MICRO-POLISHING ACTION ENAMEL SAFE NET WT 4.2 OZ (119 g) CLEAN MINT PASTE PRINCIPAL DISPLAY PANEL - 119 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 COMPANY 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 problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
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, if pain/sensitivity still persists after 4 weeks of use, please visit your 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.Warnings When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist. Stop use and ask a dentist if the 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.
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