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Drug Facts
Opalescence Whitening Sensitivity Relief Gel, Dentifrice
FDA Label NDC 51206-315
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ultradent Products, Inc. for the product Opalescence Whitening Sensitivity Relief (NDC 51206-315). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Potassium Nitrate 5% w/w
Sodium Fluoride 0.24% w/w
Purpose
Antihypersensitivity
Anticavity
Uses
- Aids in the prevention of dental cavities
- Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact
Warnings
Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor
Otc - Keep Out Of Reach Of Children
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
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 doctor. Make sure to brush all sensitive areas of the teeth.
- Children under 12 yeasrs of age: Consult a dentist or doctor.
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
Inactive Ingredients
Aqua (Water), Silica, Xylitol, Glycerin, Sorbitol, Poloxamer 407, Methyl Salicylate, Sodium Lauryl Sulfate, Carbomer, FD&C Blue No. 1 (CI 42090), FD&C Yellow No. 5 (CI 19140), Flavor (Aroma), Sodium Benzoate, Sodium Hydroxide, Sucralose, Xantham Gum
Questions Or Comments
Call toll-free 1.800.552.5512
Principal Display Panel - 4.7 Oz Tube Carton
Opalescence Whitening Toothpaste
Sensitivity Relief
Cool Mint
NET WT. 4.7 oz * 133 g 8 100 ml
FLUORIDE TOOTHPASTE
FOR SENSITIVE TEETH
* Please review the disclaimer below.
