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| Product NDC Code | 35000-731 | ||||||||||||
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| Drug Name | Colgate total 12 hr pro-shield spearmint surge |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | DENTAL | ||||||||||||
| Dosage Form | RINSE | ||||||||||||
| RxCUI drug identifier | 1599135, 1599137 |
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| Application Number | 505G(a)(3) | ||||||||||||
| Labeler Name | Colgate-Palmolive Company | ||||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Cetylpyridinium chloride 0.075%
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 vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. children 6 years to under 12 years of age supervise use children under 6 years of age do not use
| adults and children 12 years of age and older | vigorously swish 20 mL of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse. |
| children 6 years to under 12 years of age | supervise use |
| children under 6 years of age | do not use |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6
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 helps prevent and reduce plaque and gingivitis helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
Purpose
Information about the drug product’s indications for use.Purpose Antigingivitis/Antiplaque
Spl product data elements
Usually a list of ingredients in a drug product.Colgate Total 12 Hr Pro-Shield Spearmint Surge CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM CHLORIDE CETYLPYRIDINIUM WATER GLYCERIN PROPYLENE GLYCOL SORBITOL POLOXAMER 407 POTASSIUM SORBATE SACCHARIN SODIUM ANHYDROUS CITRIC ACID SUCRALOSE FD&C GREEN NO. 3 FD&C YELLOW NO. 6
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 - 500 mL Bottle Label ALCOHOL FREE Colgate ® Antigingivitis Antiplaque Mouthwash Total 12 HR PROTECTION* EVEN AFTER EATING AND DRINKING ANTIBACTERIAL Kills 99% of Germs on Contact Significantly Reduces Plaque Helps Prevent Gingivitis 10X LONGER LASTING COOL** SPEARMINT P80040924 16.9 FL OZ (1.05 PT) 500 mL PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
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 under 6 years of age. If more than used for rinsing 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 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 or symptoms of periodontitis, a serious form of gum disease.
Storage and handling
Information about safe storage and handling of the drug product.Other information this rinse is not intended to replace brushing or flossing store at 59°F to 77°F keep from freezing
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 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 or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children under 6 years of age. If more than used for rinsing 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