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| Product NDC Code | 0126-0034 | ||||
|---|---|---|---|---|---|
| Drug Name | Colgate phos-flur ortho defense alcohol free anticavity gushing grape fluoride |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | RINSE | ||||
| RxCUI drug identifier | 313029, 1721964 |
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| Application Number | M021 | ||||
| Labeler Name | Colgate Oral Pharmaceuticals, Inc. | ||||
| 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 Sodium fluoride 0.04% (0.02% 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 6 years of age and older use once a day after brushing your teeth with a toothpaste vigorously swish 10 milliliters (10 mL mark on cap or 2 teaspoonfuls) of rinse between your teeth for 1 minute then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of using without supervision children under 6 years of age ask a dentist or physician
| adults and children 6 years of age and older |
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| children under 6 years of age |
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Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sorbitol, sodium phosphate, flavor, potassium sorbate, phosphoric acid, polysorbate 20, FD&C blue no. 1, FD&C red no. 40
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 aids in the prevention of dental cavities
Purpose
Information about the drug product’s indications for use.Purpose Anticavity
Spl product data elements
Usually a list of ingredients in a drug product.Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL SODIUM PHOSPHATE POTASSIUM SORBATE PHOSPHORIC ACID POLYSORBATE 20 FD&C BLUE NO. 1 FD&C RED NO. 40
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 ® Phos•Flur ® Ortho Defense ® Anticavity Fluoride Rinse Sodium Fluoride Acidulated Phosphate Solution IDEAL PROTECTION WHILE WEARING BRACES ✓ ORTHODONTIST RECOMMENDED ✓ HELPS STRENGTHEN ENAMEL ✓ HELPS PREVENT CAVITIES GUSHING GRAPE 16.9 FL OZ (1.05 PT) 500 mL IMPORTANT: Read directions for proper use ADA Accepted American Dental Association ® P9910320 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 COMPANY New York, NY 10022
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 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
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at controlled room temperature 68 – 77° F (20 – 25°C)
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. 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