Save up to 80% by drug discount in your pharmacy with "Pharmacy Near Me - National Drug Discount Card"
You can scan QR Code(just open camera on your phone/scan by application) from the image on prescription drug discount card to save it to your mobile phone. Or just click on image if you're on mobile phone.
| Product NDC Code | 51206-302 | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Opalescence whitening |
||||||||||||||
| Type | Brand | ||||||||||||||
| Active Ingredients |
|
||||||||||||||
| Route | DENTAL | ||||||||||||||
| Dosage Form | GEL, DENTIFRICE | ||||||||||||||
| RxCUI drug identifier | 1044547 | ||||||||||||||
| Application Number | M021 | ||||||||||||||
| Labeler Name | Ultradent Products, Inc | ||||||||||||||
| Packages |
|
||||||||||||||
| 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 Sodium Fluoride 0.25% w/w
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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Glycerin, Water (Aqua), Silica, Sorbitol, Xylitol, Flavor (aroma), Poloxamer 407, Sodium Lauryl Sulfate, Carbomer, Sodium Benzoate, Sodium Hydroxide, Sucralose, Xanthan Gum, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140)
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 dental decay.
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.Opalescence Whitening Sodium Fluoride WATER SORBITOL SODIUM BENZOATE XYLITOL SILICON DIOXIDE METHYL SALICYLATE GLYCERIN SACCHARIN SODIUM FD&C BLUE NO. 1 FD&C YELLOW NO. 5 XANTHAN GUM SODIUM LAURYL SULFATE SODIUM FLUORIDE FLUORIDE ION
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 - 100 ml Tube Box Opalescence™ whitening toothpaste NET WT. 4.7 oz • 133 g • 100 ml FLUORIDE TOOTHPASTE Original Cool Mint Principal Display Panel - 100 ml Tube Box
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
Manufactured by: Ultradent Products, Inc., South Jordan, UT 84095, USA
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 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 or comments Call toll-free 1.800.552.5512
Storage and handling
Information about safe storage and handling of the drug product.Other Information Do not use if tamper-evident seal is broken Store at room temperature Contains FD&C Yellow No. 5 (tartrazine) as a color additive
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 under 6 years of age. 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